Approximately 1--3% of all couples experience recurrent pregnancy loss, and about 50-70% of all conceptions fail. The underlying molecular mechanisms causing these heartbreaking conditions, however, remain unknown.
Many cases of pregnancy loss are known to due to damage to the fetus through genetic, anatomic, endocrine, or Infectious means. When such causes are ruled out, the other source is thought to be caused by a maternal immune response.
Most of the research in this arena has focused on identifying reactions at the maternal-fetal interface in the placenta. Adrian Erlebacher and colleagues, from Harvard School of Public Health, have now, however, identified new means by which maternal immune activation can lead to pregnancy failure. Here, the authors provide a mouse model of early pregnancy loss and present data that unexpectedly links the reproductive hormone secretion system to the immune system.
The mouse model shows that when a specific immune cell receptor called CD40 is activated early in pregnancy the resulting inflammatory response caused embryo resorption. The researchers traced the molecular mechanisms underlying this process, and found that the loss of the embryo was not due to fetal damage or activity at the fetal-maternal interface, but rather because the inflammatory response ultimately caused a decrease in progesterone, the hormone responsible for preparing the body for pregnancy and maintaining it until birth.
These data make it clear that the immune system, by interfering with the reproductive hormones, may contribute to human infertility, especially in cases of recurrent pregnancy loss. Further the finding that there is a link between the immune system and the reproductive hormone secretion may provide a new means of therapy for women who suffer such repeated and early pregnancy loss by targeting the mediators of such inflammatory responses.
An accompanying commentary, by Jane Salmon at the Hospital for Special Surgery, provides an overview of the immune response system, the reproductive hormone system, and places the data from the paper by Erlebacher and colleagues in context with that and potential clinical treatments.
TITLE: Ovarian insufficiency and early pregnancy loss induced by activation of the innate immune system
AUTHOR CONTACT:
Adrian Erlebacher
Harvard School of Public Health, Boston, Massachusetts, USA.
Phone: 617-432-0924; Fax: 617-432-0084; Email: aerlebac@hsph.hardvard.edu
View the PDF of this article at:
https://www.the-jci.org/press/20645.pdf
ACCOMPANYING COMMENTARY: A noninflammatory pathway for pregnancy loss: innate immune activation?
AUTHOR CONTACT:
Jane E. Salmon
Hospital For Special Surgery, New York, New York, USA.
Phone: 212-606-1422; Fax: 212-717-1192; E-mail: salmonj@hss.edu
View the PDF of this article at:
https://www.the-jci.org/press/22258.pdf
Contact: Laurie Goodman
press_releases@the-jci.org
212-342-4159
Journal of Clinical Investigation
JCI table of contents, 1 July 2004
Pregnancy
All you need to know about pregnancy
1 to 3% of all couples experience recurrent pregnancy loss
Label:
Pregnancy Latest News
Single embryo transfer, a new understanding of factors for success
Transferring a single embryo to a woman can result in a similar number of pregnancies as double embryo transfer, while at the same time reducing the risk of multiple births and the complications due to twin pregnancies, a scientist said today at the 20th annual conference of the European Society of Human Reproduction and Embryology.
Dr. Ann Thurin, from Sahlgrenska University Hospital, Gteborg, Sweden, told the conference that her research had in a large study shown that single embryo transfer (SET) could produce an acceptable pregnancy rate while lowering the incidence of multiple pregnancies.
Dr.Thurin and her team undertook a randomised double-blind study in 11 centres - five in Sweden, two in Norway, and four in Denmark. 661 patients under 36 years of age, who were undergoing a first or second IVF cycle, and who had at least two good quality embryos available for transfer or freezing were included. The patients were randomised into two groups; the first to receive a fresh SET and if there was no live birth, a subsequent frozen SET, and the second to a double embryo transfer (DET)
"The concept of 1+1 compared with a 2-embryo transfer has not been tried before", said Dr. Thurin, "and we were pleased to see that the women who had SET had an ongoing pregnancy rate nearly as high as those who had DET (39.7% versus 43.5%)."
There were no significant differences for other variables - the average age of the women at fresh transfer was 30.9 in the SET group and 30.8 in the DET group, and the number of good quality embryos available 4.6 in both groups.
"The only problem is that SET patients might need to go through one additional frozen cycle in order to have the same chance of pregnancy, but that is offset by the lower risks for mothers and children by avoiding multiple births", said Dr. Thurin. "However, the selection of the right embryo for SET is essential and a careful assessment needs to be undertaken before a choice is made. It is also important to have a well organised and functioning freezing programme, so that embryos that are surplus after SET can be properly preserved", she said.
Abstract O-170
In another study presented at the conference, scientists said that they had identified factors which independently of other factors affected the success of IVF or ICSI. The number of blastomeres - the cells formed in the first stages of embryonic development, just after the splitting of the fertilised egg - have a clear impact on whether fertilisation will lead to 'ongoing implantation' - an implantation which is not directly aborted by the body, they said. It was found that 4-cells embryos on day 2 were superior to faster cleaved embryos.
Dr. Christina Bergh, also from the Sahlgrenska Hospital, Gteborg, told the conference that she and her team had looked at the same 661 patients studied by Dr. Thurin. They then analysed the IVF and ICSI cycles where implantation was either entirely successful or unsuccessful in its first stage i.e cycles where all transferred embryos implanted or did not implant.
Researchers had suspected for some time that the number of blastomeres could play a key role in the success of artificial reproduction techniques, said Dr. Bergh. "But until now, the only trials in this area were on a small scale and did not take confounding factors such as the age of the women and the number of good embryos into account."
Although the patients in the study were all under 36, researchers think the finding can be generalized to women of other ages. "This research is an important step towards understanding how and why implantation can be most successful, and therefore towards reducing multiple births by improving the effectiveness of single embryo transfer", said Dr. Bergh.
Abstract O-171
In a third presentation, Dr. Jan Olofsson, from the Fertility Centre Scandinavia, Gteborg, Sweden, told the conference that he believed that SET, properly carried out, was sufficiently successful for it to be introduced on a wide scale without compromising results. His team studied the outcomes of all stimulated fresh embryo IVF and ICSI cycles at the Fertility Centre in 2002, and compared them with outcomes of cycles performed in 2003, when a new Swedish law forbade the transfer of more than one embryo at a time, aside from exceptional cases where two embryos are transferred.
"In Sweden we estimate that about 70% of all stimulated IVF-treatment cycles are performed with single embryo transfer", said Dr. Olofsson, and our data show that their chances of success are almost as high as with multiple transfer, but without the additional cost, both physical and financial, of multiple pregnancies."
Dr. Olofsson's team found little difference between the number of pregnancies and implantation rate between the two years. But the number of multiple births declined considerably - by 29% in 2003. "We will follow these results by looking at all deliveries in 2003", he said, "and are optimistic that, when we add in the results from the frozen and thawed cycles, the pregnancy rate will rise yet higher. We have shown that SET works and believe that the Swedish model could be extrapolated to other countries with similar results."
Abstract O-169
Further information (media enquiries only):
Mary Rice, information officer
Tel: 32-2-289-0930
Fax: 32-2-513-0577
Mobile: 44-0-7803-048897
Email: mary.rice@blueprintpartners.be
Emma Mason, information officer
Tel: 44-0-1376-563090
Fax: 44-0-1376-563272
Mobile: 44-0-7711-296-986
Email: wordmason@aol.com
Press Office: (Sunday 27 June - Wednesday 30 June)
Mary Rice, Emma Mason, Janet Blmli
Tel: 49-0-30-3038-81002 or 49-0-30-3038-81003
Fax: 49-0-30-3038-81001
Contact: Mary Rice
mary.rice@blueprintpartners.be
32-0-2-289-0930
European Society for Human Reproduction and Embryology
Source: medicalnewstoday.com
Dr. Ann Thurin, from Sahlgrenska University Hospital, Gteborg, Sweden, told the conference that her research had in a large study shown that single embryo transfer (SET) could produce an acceptable pregnancy rate while lowering the incidence of multiple pregnancies.
Dr.Thurin and her team undertook a randomised double-blind study in 11 centres - five in Sweden, two in Norway, and four in Denmark. 661 patients under 36 years of age, who were undergoing a first or second IVF cycle, and who had at least two good quality embryos available for transfer or freezing were included. The patients were randomised into two groups; the first to receive a fresh SET and if there was no live birth, a subsequent frozen SET, and the second to a double embryo transfer (DET)
"The concept of 1+1 compared with a 2-embryo transfer has not been tried before", said Dr. Thurin, "and we were pleased to see that the women who had SET had an ongoing pregnancy rate nearly as high as those who had DET (39.7% versus 43.5%)."
There were no significant differences for other variables - the average age of the women at fresh transfer was 30.9 in the SET group and 30.8 in the DET group, and the number of good quality embryos available 4.6 in both groups.
"The only problem is that SET patients might need to go through one additional frozen cycle in order to have the same chance of pregnancy, but that is offset by the lower risks for mothers and children by avoiding multiple births", said Dr. Thurin. "However, the selection of the right embryo for SET is essential and a careful assessment needs to be undertaken before a choice is made. It is also important to have a well organised and functioning freezing programme, so that embryos that are surplus after SET can be properly preserved", she said.
Abstract O-170
In another study presented at the conference, scientists said that they had identified factors which independently of other factors affected the success of IVF or ICSI. The number of blastomeres - the cells formed in the first stages of embryonic development, just after the splitting of the fertilised egg - have a clear impact on whether fertilisation will lead to 'ongoing implantation' - an implantation which is not directly aborted by the body, they said. It was found that 4-cells embryos on day 2 were superior to faster cleaved embryos.
Dr. Christina Bergh, also from the Sahlgrenska Hospital, Gteborg, told the conference that she and her team had looked at the same 661 patients studied by Dr. Thurin. They then analysed the IVF and ICSI cycles where implantation was either entirely successful or unsuccessful in its first stage i.e cycles where all transferred embryos implanted or did not implant.
Researchers had suspected for some time that the number of blastomeres could play a key role in the success of artificial reproduction techniques, said Dr. Bergh. "But until now, the only trials in this area were on a small scale and did not take confounding factors such as the age of the women and the number of good embryos into account."
Although the patients in the study were all under 36, researchers think the finding can be generalized to women of other ages. "This research is an important step towards understanding how and why implantation can be most successful, and therefore towards reducing multiple births by improving the effectiveness of single embryo transfer", said Dr. Bergh.
Abstract O-171
In a third presentation, Dr. Jan Olofsson, from the Fertility Centre Scandinavia, Gteborg, Sweden, told the conference that he believed that SET, properly carried out, was sufficiently successful for it to be introduced on a wide scale without compromising results. His team studied the outcomes of all stimulated fresh embryo IVF and ICSI cycles at the Fertility Centre in 2002, and compared them with outcomes of cycles performed in 2003, when a new Swedish law forbade the transfer of more than one embryo at a time, aside from exceptional cases where two embryos are transferred.
"In Sweden we estimate that about 70% of all stimulated IVF-treatment cycles are performed with single embryo transfer", said Dr. Olofsson, and our data show that their chances of success are almost as high as with multiple transfer, but without the additional cost, both physical and financial, of multiple pregnancies."
Dr. Olofsson's team found little difference between the number of pregnancies and implantation rate between the two years. But the number of multiple births declined considerably - by 29% in 2003. "We will follow these results by looking at all deliveries in 2003", he said, "and are optimistic that, when we add in the results from the frozen and thawed cycles, the pregnancy rate will rise yet higher. We have shown that SET works and believe that the Swedish model could be extrapolated to other countries with similar results."
Abstract O-169
Further information (media enquiries only):
Mary Rice, information officer
Tel: 32-2-289-0930
Fax: 32-2-513-0577
Mobile: 44-0-7803-048897
Email: mary.rice@blueprintpartners.be
Emma Mason, information officer
Tel: 44-0-1376-563090
Fax: 44-0-1376-563272
Mobile: 44-0-7711-296-986
Email: wordmason@aol.com
Press Office: (Sunday 27 June - Wednesday 30 June)
Mary Rice, Emma Mason, Janet Blmli
Tel: 49-0-30-3038-81002 or 49-0-30-3038-81003
Fax: 49-0-30-3038-81001
Contact: Mary Rice
mary.rice@blueprintpartners.be
32-0-2-289-0930
European Society for Human Reproduction and Embryology
Source: medicalnewstoday.com
Label:
Pregnancy Latest News
Trends in smoking in Great Britain
Smoking prevalence in the UK has fallen steadily over the last two decades. In 2000, 27% of adults aged 16 and over in Great Britain smoked cigarettes compared with 40% in 1978. However, most of this decline occurred in the 1970s and 1980s. In the 1990s the decline in smoking prevalence among adults levelled off (Office for National Statistics, 2001).
The prevalence of smoking is higher among people in manual than non-manual social classes (31% compared with 23% in England in 2000). The widening of this gap over the past 20 years reflects a steeper decline in smoking prevalence among non-manual classes compared with manual classes.
However, between 1998 and 2000, overall prevalence of cigarette smoking among those in manual groups in England fell by two percentage points. Although this is a statistically significant fall, the Office for National Statistics advises caution about a year on year comparison because the data may have been affected by recent changes in assessing socio-economic groups (Office for National Statistics, 2001).
The social class differentials in smoking are reflected in the social gradients of deaths caused by smoking. Among men, smoking accounts for over half of the difference in risk of premature death between social classes (Jarvis and Wardle, 1999). Premature deaths from lung cancer are five times higher among men in unskilled manual work compared to those in professional occupations (DH, 1998a).
Pregnant women
Two data sources are available to estimate smoking among pregnant women in England. The Infant Feeding Survey, which is the main source of information used by the Department of Health to monitor progress towards the tobacco white paper target on smoking in pregnancy, is conducted every five years among women who have recently given birth. The data on smoking are both retrospective and unvalidated by biochemical measures.
The 2000 survey gives prevalence figures for England of 23% for 1995 (the figure used for the baseline of the tobacco white paper target) and 18% for 2000 (DH, 2001c).
From 1992 to 2000, the former Health Education Authority (HEA) conducted annual surveys among pregnant women in England. The proportion of pregnant smokers fluctuated over that time (Owen et al.,1998; Owen and Penn, 1999). In 1999 nearly a third of women (31.5%) smoked during pregnancy compared to 27% in 1992. Smoking was especially prevalent among women who were single, separated or divorced (55.5%), in social groups DE (52.2%), living in rented local authority accommodation (57.3%), or who had left full-time education at 15 and 16 years old (52.9% and 42.7% respectively) (Owen and McNeill, 2001).
When a sample of responses was validated by biochemical measure (saliva cotinine) it revealed an under-reporting of the current smoking status among pregnant women of about 3%. This suggests that government estimates of smoking in pregnancy may be underestimates (Owen and McNeill, 2001).
Young people
In 2000, an estimated 10% of children aged 11-15 were regular smokers, an increase from 9% in 1999 (DH, 2001a). Smoking behaviour in this group has fluctuated considerably over time, showing a low of 8% in 1988 and a high of 13% in 1996 (DH, 2000c). As the majority of smokers take up the habit in their teens, any increases in the rates of young smokers will eventually feed through into adult smoking rates.
Black and minority ethnic groups
Cigarette smoking among minority ethnic groups is generally less than among the UK population as a whole (27%), but a more detailed examination reveals important differences between and within groups. The smoking rate among Bangladeshi men is particularly high (44%). Smoking rates are even higher among middle-aged and older Bangladeshi men (50% and 54% for men aged between 35-54 and 55+ years respectively). This same group of men also has high rates of chewing tobacco products.
Tobacco chewing is particularly high among older Bangladeshi women: 43% of women aged 35-54 years and 56% of women aged over 55 years chew tobacco (DH, 1999a).
Poverty and smoking
Traditional measures of social class tend to underplay the extent to which high smoking rates have not decreased in the poorest sections of society. Recent studies have shown that smoking levels have remained virtually unchanged among those in the poorest groups, and among lone mothers smoking levels have risen (Marsh and McKay, 1994; Dorsett and Marsh 1998; Jarvis, 1998). In a detailed study, lone parents living in rented accommodation and relying on social security benefits were found to have smoking levels in excess of 75% (Dorsett and Marsh, 1998).
HEALTH DEVELOPMENT AGENCY, UK
Source: medicalnewstoday.com
The prevalence of smoking is higher among people in manual than non-manual social classes (31% compared with 23% in England in 2000). The widening of this gap over the past 20 years reflects a steeper decline in smoking prevalence among non-manual classes compared with manual classes.
However, between 1998 and 2000, overall prevalence of cigarette smoking among those in manual groups in England fell by two percentage points. Although this is a statistically significant fall, the Office for National Statistics advises caution about a year on year comparison because the data may have been affected by recent changes in assessing socio-economic groups (Office for National Statistics, 2001).
The social class differentials in smoking are reflected in the social gradients of deaths caused by smoking. Among men, smoking accounts for over half of the difference in risk of premature death between social classes (Jarvis and Wardle, 1999). Premature deaths from lung cancer are five times higher among men in unskilled manual work compared to those in professional occupations (DH, 1998a).
Pregnant women
Two data sources are available to estimate smoking among pregnant women in England. The Infant Feeding Survey, which is the main source of information used by the Department of Health to monitor progress towards the tobacco white paper target on smoking in pregnancy, is conducted every five years among women who have recently given birth. The data on smoking are both retrospective and unvalidated by biochemical measures.
The 2000 survey gives prevalence figures for England of 23% for 1995 (the figure used for the baseline of the tobacco white paper target) and 18% for 2000 (DH, 2001c).
From 1992 to 2000, the former Health Education Authority (HEA) conducted annual surveys among pregnant women in England. The proportion of pregnant smokers fluctuated over that time (Owen et al.,1998; Owen and Penn, 1999). In 1999 nearly a third of women (31.5%) smoked during pregnancy compared to 27% in 1992. Smoking was especially prevalent among women who were single, separated or divorced (55.5%), in social groups DE (52.2%), living in rented local authority accommodation (57.3%), or who had left full-time education at 15 and 16 years old (52.9% and 42.7% respectively) (Owen and McNeill, 2001).
When a sample of responses was validated by biochemical measure (saliva cotinine) it revealed an under-reporting of the current smoking status among pregnant women of about 3%. This suggests that government estimates of smoking in pregnancy may be underestimates (Owen and McNeill, 2001).
Young people
In 2000, an estimated 10% of children aged 11-15 were regular smokers, an increase from 9% in 1999 (DH, 2001a). Smoking behaviour in this group has fluctuated considerably over time, showing a low of 8% in 1988 and a high of 13% in 1996 (DH, 2000c). As the majority of smokers take up the habit in their teens, any increases in the rates of young smokers will eventually feed through into adult smoking rates.
Black and minority ethnic groups
Cigarette smoking among minority ethnic groups is generally less than among the UK population as a whole (27%), but a more detailed examination reveals important differences between and within groups. The smoking rate among Bangladeshi men is particularly high (44%). Smoking rates are even higher among middle-aged and older Bangladeshi men (50% and 54% for men aged between 35-54 and 55+ years respectively). This same group of men also has high rates of chewing tobacco products.
Tobacco chewing is particularly high among older Bangladeshi women: 43% of women aged 35-54 years and 56% of women aged over 55 years chew tobacco (DH, 1999a).
Poverty and smoking
Traditional measures of social class tend to underplay the extent to which high smoking rates have not decreased in the poorest sections of society. Recent studies have shown that smoking levels have remained virtually unchanged among those in the poorest groups, and among lone mothers smoking levels have risen (Marsh and McKay, 1994; Dorsett and Marsh 1998; Jarvis, 1998). In a detailed study, lone parents living in rented accommodation and relying on social security benefits were found to have smoking levels in excess of 75% (Dorsett and Marsh, 1998).
HEALTH DEVELOPMENT AGENCY, UK
Source: medicalnewstoday.com
Label:
Pregnancy Latest News
European regulators extend missed pill window for Cerazette, Contraceptive without estrogen
The 'missed pill window' for Cerazette, the estrogen-free contraceptive pill, has been extended from 3 to 12 hours, following an agreement reached by MRFG, the responsible European regulatory body and Organon.(1)
This means that for the first time women can choose an oral contraceptive that is free of estrogen and its associated side effects, but with comparable reliability and margin of error as the combined pill.(2) Cerazette is the first and only estrogen-free pill that offers consistent ovulation inhibition.
Current prescribing information for "progestogen-only" pills rules that women should take their pill within a three-hour window each day, leaving little room for error. This reflects the fact that such products do not consistently prevent ovulation. Now, based on evidence of Cerazette's consistent inhibition of ovulation, its window will be extended to 12 hours. This will further widen the appeal of this estrogen-free pill.(3)
"A significant number of women - who cannot or do not want to take estrogen - stand to benefit from an oral contraceptive that does not contain estrogen. However, the appeal of traditional progestogen-only pills has always been limited by their lower reliability and more stringent pill-taking regimen compared to the combined pill. Cerazette has overturned that," said Dr Ulrich Karck, director of Stuttgart's Women's Hospital in Germany. "Cerazette has already proved tremendously popular since its introduction in Germany. The extension of its missed pill window will no doubt increase its appeal to an even greater extent."(4)
New study findings confirm prevention of ovulation
The new evidence was presented today at the 8th Congress of the European Society of Contraception. Dr Tjeerd Korver from the clinical development group of Organon presented study results showing that Cerazette consistently inhibits ovulation even when tablets are taken 12 hours late. More than 100 women took part in the study.
"The study shows that Cerazette inhibits ovulation to the extent known from the conventional combined pill," says Dr Korver. "It means women can take an estrogen-free pill just as conveniently as a combined pill and with the same confidence."
Convenience and reliability without estrogen
Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
However, Cerazette's benefits do not just lie in its estrogen-free composition. With its new wider window of confidence for missed pills, Cerazette's margin for user error will be extended.
Cerazette may initially cause irregular bleeding. Some women may also have amenorrhea. However, after a few months most women will have less frequent bleeding episodes.
MRFG's approval underlines Cerazette's consistent effect on ovulation, and will increase user confidence in this estrogen-free product. This, alongside Cerazette's continuous 28-day regimen, results in an easy-to-take pill that is free of estrogen-related side effects but without any compromise of high contraceptive efficacy.(5)
About Organon
Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia.
Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
1. The change to the official European prescribing information for Cerazette was agreed by the Mutual Recognition Facilitation Group (MRFG) on 27th May 2004. The MRFG was established by the Member states in March 1995 and held its first meeting in June of that year. Next step is to implement the new prescribing information by national regulatory authorities before being applicable in individual countries.
2. Traditional contraceptive pills without estrogen are known as "progestogen-only" pills (POPs), or "mini pills". The progestogen causes mucus in the cervix to thicken, which thereby prevents the penetration of sperm into the uterus and the tubes. This is a primary mode of action for conventional POP's. This effect on cervical mucus has been found to last no more than 27 hours - hence the short margin for error (3 hours) traditionally applied to POPs. However, Cerazette has a different mechanism of action from conventional POPs. Because Cerazette works by consistently preventing ovulation (as well thickening cervical mucus), studies have shown that its contraceptive efficacy is maintained for up to 36 hours after taking a tablet - hence the extension of the missed pill window from 3 to 12 hours. This is similar to that applied to combined pills (which contain both estrogen and progestogen).
3. Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
4. Karck U. XVII World Congress of Gynecology and Obstetrics, Santiago,Chile, 2003.
5. Each tablet of Cerazette contains 75 micrograms of the progestogen hormone desogestrel. Tablets are taken each day for a cycle of 28 days. A recent study to assess the efficacy of Cerazette found pregnancy rates were much lower than with a conventional POP (a Cerazette Pearl Index of 0.4 versus a POP Pearl Index of 1.6). (Rice CF, Killick SR, Dieben T, Coelingh Bennink H. A comparison of the inhibition of ovulation achieved by desogestrel 75 mcg and levonorgestrel 30 mcg daily. Hum Reprod 1999; 14: 982-5).
The pregnancy rates found with Cerazette were in the range associated with traditional combined pills. The study reported by Dr Korver at the ESC congress showed that ovulation was prevented in 99% of cases, even when tablets were taken 12 hours late. Thus, accidental delays in tablet taking of up to 12 hours do not jeopardize the ovulation inhibition and contraceptive efficacy of Cerazette.
N.V. Organon (Communications)
Visiting address:
Molenstraat 110
5342 CC Oss
The Netherlands
Mailing address:
P.O. Box 20
5340 BH Oss
The Netherlands
Phone
+31.412.66.54.40
Fax:
+31.412.66.25.68
Email address:
monique.mols@organon.com
This means that for the first time women can choose an oral contraceptive that is free of estrogen and its associated side effects, but with comparable reliability and margin of error as the combined pill.(2) Cerazette is the first and only estrogen-free pill that offers consistent ovulation inhibition.
Current prescribing information for "progestogen-only" pills rules that women should take their pill within a three-hour window each day, leaving little room for error. This reflects the fact that such products do not consistently prevent ovulation. Now, based on evidence of Cerazette's consistent inhibition of ovulation, its window will be extended to 12 hours. This will further widen the appeal of this estrogen-free pill.(3)
"A significant number of women - who cannot or do not want to take estrogen - stand to benefit from an oral contraceptive that does not contain estrogen. However, the appeal of traditional progestogen-only pills has always been limited by their lower reliability and more stringent pill-taking regimen compared to the combined pill. Cerazette has overturned that," said Dr Ulrich Karck, director of Stuttgart's Women's Hospital in Germany. "Cerazette has already proved tremendously popular since its introduction in Germany. The extension of its missed pill window will no doubt increase its appeal to an even greater extent."(4)
New study findings confirm prevention of ovulation
The new evidence was presented today at the 8th Congress of the European Society of Contraception. Dr Tjeerd Korver from the clinical development group of Organon presented study results showing that Cerazette consistently inhibits ovulation even when tablets are taken 12 hours late. More than 100 women took part in the study.
"The study shows that Cerazette inhibits ovulation to the extent known from the conventional combined pill," says Dr Korver. "It means women can take an estrogen-free pill just as conveniently as a combined pill and with the same confidence."
Convenience and reliability without estrogen
Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
However, Cerazette's benefits do not just lie in its estrogen-free composition. With its new wider window of confidence for missed pills, Cerazette's margin for user error will be extended.
Cerazette may initially cause irregular bleeding. Some women may also have amenorrhea. However, after a few months most women will have less frequent bleeding episodes.
MRFG's approval underlines Cerazette's consistent effect on ovulation, and will increase user confidence in this estrogen-free product. This, alongside Cerazette's continuous 28-day regimen, results in an easy-to-take pill that is free of estrogen-related side effects but without any compromise of high contraceptive efficacy.(5)
About Organon
Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia.
Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
1. The change to the official European prescribing information for Cerazette was agreed by the Mutual Recognition Facilitation Group (MRFG) on 27th May 2004. The MRFG was established by the Member states in March 1995 and held its first meeting in June of that year. Next step is to implement the new prescribing information by national regulatory authorities before being applicable in individual countries.
2. Traditional contraceptive pills without estrogen are known as "progestogen-only" pills (POPs), or "mini pills". The progestogen causes mucus in the cervix to thicken, which thereby prevents the penetration of sperm into the uterus and the tubes. This is a primary mode of action for conventional POP's. This effect on cervical mucus has been found to last no more than 27 hours - hence the short margin for error (3 hours) traditionally applied to POPs. However, Cerazette has a different mechanism of action from conventional POPs. Because Cerazette works by consistently preventing ovulation (as well thickening cervical mucus), studies have shown that its contraceptive efficacy is maintained for up to 36 hours after taking a tablet - hence the extension of the missed pill window from 3 to 12 hours. This is similar to that applied to combined pills (which contain both estrogen and progestogen).
3. Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
4. Karck U. XVII World Congress of Gynecology and Obstetrics, Santiago,Chile, 2003.
5. Each tablet of Cerazette contains 75 micrograms of the progestogen hormone desogestrel. Tablets are taken each day for a cycle of 28 days. A recent study to assess the efficacy of Cerazette found pregnancy rates were much lower than with a conventional POP (a Cerazette Pearl Index of 0.4 versus a POP Pearl Index of 1.6). (Rice CF, Killick SR, Dieben T, Coelingh Bennink H. A comparison of the inhibition of ovulation achieved by desogestrel 75 mcg and levonorgestrel 30 mcg daily. Hum Reprod 1999; 14: 982-5).
The pregnancy rates found with Cerazette were in the range associated with traditional combined pills. The study reported by Dr Korver at the ESC congress showed that ovulation was prevented in 99% of cases, even when tablets were taken 12 hours late. Thus, accidental delays in tablet taking of up to 12 hours do not jeopardize the ovulation inhibition and contraceptive efficacy of Cerazette.
N.V. Organon (Communications)
Visiting address:
Molenstraat 110
5342 CC Oss
The Netherlands
Mailing address:
P.O. Box 20
5340 BH Oss
The Netherlands
Phone
+31.412.66.54.40
Fax:
+31.412.66.25.68
Email address:
monique.mols@organon.com
Label:
Pregnancy Latest News
Doctors urged to keep check on daughters of women who used pregnancy drug three decades ago Australia
Women whose mothers took a synthetic oestrogen called Stilboestrol, known also as Diethylstilboestrol (DES) during pregnancy some three or four decades ago would not be in fear of contracting a rare vaginal cancer but they may have other vaginal abnormalities which should be checked out by a gynaecologist, if they have not already done so, Australia's medicines watchdog, the Therapeutic Goods Administration (TGA), announced today.
Principal Medical Adviser with the TGA, Dr John McEwen, said that the Adverse Drug Reactions Advisory Committee (ADRAC) has reminded doctors in its latest Bulletin that daughters of women who took the drug in the 1950s and 1960s to prevent miscarriages should ensure that they follow the current national cervical and breast screening recommendations and should be reviewed by a gynaecologist, if they have not been previously.
Dr McEwen said in that in1971, an association was demonstrated between exposure in the womb to DES, and the development of the rare vaginal cancer CCAC in exposed daughters who were diagnosed at ages up to 22 years.
"In Australia there have only been 15 reported cases of the development of a rare cancer, clear cell adenocarcinoma (CCAC) of the vagina in women whose mothers had taken diethystilboestrol but it is considered that since the use of the drug for this purpose stopped in about 1972, all cancers should have been detected by now," Dr McEwen said.
He said, however that since the 1971 study other adverse effects associated with DES have been identified in DES daughters including:
-- vaginal and cervical adenosis is very common, with reported incidence as high as 90%
-- other histological and structural reproductive tract abnormalities have been reported (incidences range from 18% - 58%)
-- occurrence of cervical and vaginal dysplasia, squamous cell carcinoma-in-situ, and high grade squamous intraepithelial lesions is about doubled
-- infertility rates are slightly increased
-- pregnancy complication rates, such as premature deliveries, miscarriages, ectopic pregnancies and pre-eclampsia are increased
Dr McEwen said for the women who took DES ('DES mothers'), a small increase in the rate of breast cancer has been reported. The sons exposed to DES in utero ('DES sons') have an increased occurrence of epididymal cysts. Careful surveillance on the next generation is being maintained ('DES grandchildren'), but there is no clear evidence to date of adverse effects in the children of DES daughters or sons.
Therapeutic Goods Administration, Australia
Source: medicalnewstoday.com
Principal Medical Adviser with the TGA, Dr John McEwen, said that the Adverse Drug Reactions Advisory Committee (ADRAC) has reminded doctors in its latest Bulletin that daughters of women who took the drug in the 1950s and 1960s to prevent miscarriages should ensure that they follow the current national cervical and breast screening recommendations and should be reviewed by a gynaecologist, if they have not been previously.
Dr McEwen said in that in1971, an association was demonstrated between exposure in the womb to DES, and the development of the rare vaginal cancer CCAC in exposed daughters who were diagnosed at ages up to 22 years.
"In Australia there have only been 15 reported cases of the development of a rare cancer, clear cell adenocarcinoma (CCAC) of the vagina in women whose mothers had taken diethystilboestrol but it is considered that since the use of the drug for this purpose stopped in about 1972, all cancers should have been detected by now," Dr McEwen said.
He said, however that since the 1971 study other adverse effects associated with DES have been identified in DES daughters including:
-- vaginal and cervical adenosis is very common, with reported incidence as high as 90%
-- other histological and structural reproductive tract abnormalities have been reported (incidences range from 18% - 58%)
-- occurrence of cervical and vaginal dysplasia, squamous cell carcinoma-in-situ, and high grade squamous intraepithelial lesions is about doubled
-- infertility rates are slightly increased
-- pregnancy complication rates, such as premature deliveries, miscarriages, ectopic pregnancies and pre-eclampsia are increased
Dr McEwen said for the women who took DES ('DES mothers'), a small increase in the rate of breast cancer has been reported. The sons exposed to DES in utero ('DES sons') have an increased occurrence of epididymal cysts. Careful surveillance on the next generation is being maintained ('DES grandchildren'), but there is no clear evidence to date of adverse effects in the children of DES daughters or sons.
Therapeutic Goods Administration, Australia
Source: medicalnewstoday.com
Label:
Pregnancy Latest News
Protecting women against rubella: Guidance on the use of MMR vaccine
Rubella (German measles) is a mild illness in most people but if caught in the early stages of pregnancy, it can severely damage the unborn child. If a pregnant woman catches it early in her pregnancy, it can seriously harm her unborn baby's sight, hearing, heart and brain. This condition is called congenital rubella syndrome (CRS).
WHO NEEDS TO BE PROTECTED AGAINST RUBELLA?
Children are recommended to have measles-mumps-rubella (MMR) vaccine around 13 months of age and again before starting school. The reason rubella is included in the childhood immunisation programme is to prevent children passing rubella virus to their pregnant mothers or mothers' pregnant friends.
It is also important to immunise women of childbearing age who have either not been immunised with a rubella-containing vaccine or who have been found to be rubella seronegative (not having protective antibodies to rubella) either through pre-conception screening, or antenatal screening.
Those found to be unprotected should be immunised with MMR vaccine to avoid the risk of transmitting rubella to pregnant patients. All health professionals, both male and female, should be screened.
WHY HAVE WE SWITCHED FROM USING SINGLE RUBELLA VACCINE TO MMR VACCINE?
Demand for single rubella vaccine has declined around the world as other countries use MMR vaccine as the internationally recognised vaccine to protect women of childbearing age not previously protected against rubella.
WHAT HAPPENS IN OTHER COUNTRIES?
Other countries use MMR as the internationally recognised vaccine against measles, mumps and rubella diseases as a two-dose schedule in childhood and as protection for women of childbearing age not previously protected against rubella.
The WHO strongly supports the use of MMR vaccine on the grounds of its convincing record of safety and efficacy. Using MMR to protect women of childbearing age is in line with WHO recommendations
BUT I HAVE ALREADY HAD MEASLES AND MUMPS DISEASES SO I DON'T NEED TO BE IMMUNISED AGAINST THEM.
If you have already had measles or mumps, you will not have a problem with being exposed to those viruses again. It's like any one of us who is immune meeting someone with the disease - the infection can't get established. If by chance you are not immune to measles or mumps, then you will benefit from MMR vaccination. Once immune to these diseases, you are no longer able to catch and pass these infections to your baby.
SHOULD WOMEN WHO ARE FOUND TO BE RUBELLA SERONEGATIVE RECEIVE ONE OR TWO DOSES OF MMR VACCINE?
97-99% of people will be immune to rubella after one dose of MMR vaccine so only one dose of MMR vaccine is necessary to give good protection against rubella 1, 2.
Two doses of MMR vaccine are required to give good protection against measles and mumps and can be given 3 months apart 3, 4, 5.
HOW LONG SHOULD A WOMAN AVOID BECOMING PREGNANT AFTER RECEIVING MMR VACCINE?
Because of the known association between wild rubella virus and congenital rubella syndrome (CRS), there is a theoretical risk that rubella vaccine could cause CRS. The possibility that rubella vaccine could cause CRS has been carefully studied and the results are very reassuring that nobody has found any evidence that MMR vaccine can cause congenital rubella syndrome.
Nevertheless, women are advised to avoid pregnancy for one month after receiving a rubella-containing vaccine. This advice is the same in the UK and the US.
BUT I HAVE BEEN TOLD I SHOULD WAIT FOR 3 MONTHS BEFORE GETTING PREGNANT.
The US Advisory Committee on Immunization Practices (ACIP) carried out a review recently of data from the US, UK, Sweden and Germany on 680 live births to susceptible women who were inadvertently vaccinated either 3 months before or during the early weeks of pregnancy with rubella vaccine. They found that none of the infants were born with congenital rubella syndrome (CRS). Following this review, ACIP changed their guidance of avoiding pregnancy following MMR vaccine from 3 months to 28 days in 2001 , 6. The UK has recommended a one-month interval since 1996. The Summary of Product Characteristics (SPC) for some MMR vaccines may still recommend that a 3 month gap be left between MMR vaccine and becoming pregnant but the UK and US advice is the most up to date and should be followed.
I AM TRYING FOR A BABY AND I DON'T KNOW IF I HAVE BEEN VACCINATED FOR RUBELLA. CAN I ASK MY GP OR CLINIC FOR A TEST?
Yes, you can ask your GP or clinic for a test to check your rubella antibodies before becoming pregnant. This is a wise move particularly if you can't remember if you've been vaccinated. But if you don't have rubella antibodies and need a dose of MMR, make sure that you avoid getting pregnant for one month after the jab.
I AM PREGNANT - IF MY 13 MONTH OLD CHILD HAS THE MMR VACCINE, AM I PUTTING MY BABY AT RISK FROM THE DISEASES FROM THE LIVE VACCINES?
It is not possible for anyone to catch any of the diseases that the vaccine protects against from a child recently immunised with MMR. So both you and your unborn baby are quite safe.
CAN BREAST-FEEDING WOMEN BE GIVEN MMR VACCINE?
MMR vaccine can be given to breast-feeding mothers without any risk to their baby. Very occasionally rubella vaccine virus has been found in breast milk but this has not caused any symptoms in the baby 7, 8, 9. The vaccine does not work when taken orally. There is no evidence of mumps and measles vaccine viruses being found in breast milk.
DOESN'T MMR VACCINATION CAUSE AUTISM?
There is no credible evidence of a link between MMR and autism - and there is an ever-increasing body of research which shows no evidence of a link.
The World Health Organisation describes MMR as a "highly effective vaccine which has an outstanding safety record".
CAN MMR VACCINE BE ADMINISTERED SIMULTANEOUSLY WITH ANTI-RHO (D) (ANTIBODY THAT IS GIVEN TO RHESUS NEGATIVE WOMEN) AFTER GIVING BIRTH?
Yes. It may be administered at the same time as rubella vaccine provided that separate syringes are used. The low dose of anti-Rho (D) globulin has been shown not to interfere with rubella vaccine, 10. Similarly as MMR is now the recommended vaccine the same advice applies, as issued by the Center for Disease Control (CDC) in February 2002, 11. If not given simultaneously, it should be given 3 months after anti-Rho (D).
HOW IS MMR VACCINE MADE?
MMR vaccine is made from live, but weakened measles, mumps and rubella viruses. The weakened viruses are grown either in chick embryo tissue cultures (mumps and measles) or in the human diploid cell line MRC-5 before being extensively purified, removing all traces of the cells. The viruses are then dried to a powder. The final product, in addition to the viruses, contains amino acids, human albumin, lactose, mannitol and sorbitol. It may also contain trace amounts of neomycin. The vaccine is suspended in sterile water before injection.
This article comes from the UK Department of Health
References
1 - Chu SY et al. Rubella antibody persistence after immunisation. JAVA 1988: 259; 3133-6
2 - O'Shea et al. Persistence of rubella antibody 8-18 years after vaccination. BMJ 1984:288; 1043
3 - Morse D et al. Outbreak of measles in a teenage school population: the need to immunise susceptible adolescents. Epidemiol Infect. 1994 Oct;113(2):355-65 Epidemiol Infect. 1994 ;113:355-65
4 - Fescharek R et al. Measles-mumps vaccination in the FRG: an empirical analysis after 14 years of use. Efficacy and analysis of vaccine failure. Vaccine 1990: 8; 333-6.
5 - Calvert et al. Commun Dis Rep CDR Rev. 1994 27;4(6):R70-3
6 - MMWR weekly December 14,2001/50(49); 1117
7 - Buimovici-Klein E et al, Isolation of rubella virus in milk after postpartum immunization. J Pediatr 91:939-943, 1977.
8 - Landes RD et al. Neonatal rubella following postpartum maternal immunisation. J Pediatr 97:465-467, 1980.
9 - Losonsky GA et al. Effect of immunization against rubella on lactation products. Development and characterization of specific immunologic reactivity in breast-milk J Infect Dis 145:654-660, 1982.
10 - Black et al. 1983. Post-partum rubella immunisation: a controlled trial of two vaccines. Lancet 29;2(8357);990-2). 11 - www.cdc.gov/nip/publications/pink/genrec.rtf
WHO NEEDS TO BE PROTECTED AGAINST RUBELLA?
Children are recommended to have measles-mumps-rubella (MMR) vaccine around 13 months of age and again before starting school. The reason rubella is included in the childhood immunisation programme is to prevent children passing rubella virus to their pregnant mothers or mothers' pregnant friends.
It is also important to immunise women of childbearing age who have either not been immunised with a rubella-containing vaccine or who have been found to be rubella seronegative (not having protective antibodies to rubella) either through pre-conception screening, or antenatal screening.
Those found to be unprotected should be immunised with MMR vaccine to avoid the risk of transmitting rubella to pregnant patients. All health professionals, both male and female, should be screened.
WHY HAVE WE SWITCHED FROM USING SINGLE RUBELLA VACCINE TO MMR VACCINE?
Demand for single rubella vaccine has declined around the world as other countries use MMR vaccine as the internationally recognised vaccine to protect women of childbearing age not previously protected against rubella.
WHAT HAPPENS IN OTHER COUNTRIES?
Other countries use MMR as the internationally recognised vaccine against measles, mumps and rubella diseases as a two-dose schedule in childhood and as protection for women of childbearing age not previously protected against rubella.
The WHO strongly supports the use of MMR vaccine on the grounds of its convincing record of safety and efficacy. Using MMR to protect women of childbearing age is in line with WHO recommendations
BUT I HAVE ALREADY HAD MEASLES AND MUMPS DISEASES SO I DON'T NEED TO BE IMMUNISED AGAINST THEM.
If you have already had measles or mumps, you will not have a problem with being exposed to those viruses again. It's like any one of us who is immune meeting someone with the disease - the infection can't get established. If by chance you are not immune to measles or mumps, then you will benefit from MMR vaccination. Once immune to these diseases, you are no longer able to catch and pass these infections to your baby.
SHOULD WOMEN WHO ARE FOUND TO BE RUBELLA SERONEGATIVE RECEIVE ONE OR TWO DOSES OF MMR VACCINE?
97-99% of people will be immune to rubella after one dose of MMR vaccine so only one dose of MMR vaccine is necessary to give good protection against rubella 1, 2.
Two doses of MMR vaccine are required to give good protection against measles and mumps and can be given 3 months apart 3, 4, 5.
HOW LONG SHOULD A WOMAN AVOID BECOMING PREGNANT AFTER RECEIVING MMR VACCINE?
Because of the known association between wild rubella virus and congenital rubella syndrome (CRS), there is a theoretical risk that rubella vaccine could cause CRS. The possibility that rubella vaccine could cause CRS has been carefully studied and the results are very reassuring that nobody has found any evidence that MMR vaccine can cause congenital rubella syndrome.
Nevertheless, women are advised to avoid pregnancy for one month after receiving a rubella-containing vaccine. This advice is the same in the UK and the US.
BUT I HAVE BEEN TOLD I SHOULD WAIT FOR 3 MONTHS BEFORE GETTING PREGNANT.
The US Advisory Committee on Immunization Practices (ACIP) carried out a review recently of data from the US, UK, Sweden and Germany on 680 live births to susceptible women who were inadvertently vaccinated either 3 months before or during the early weeks of pregnancy with rubella vaccine. They found that none of the infants were born with congenital rubella syndrome (CRS). Following this review, ACIP changed their guidance of avoiding pregnancy following MMR vaccine from 3 months to 28 days in 2001 , 6. The UK has recommended a one-month interval since 1996. The Summary of Product Characteristics (SPC) for some MMR vaccines may still recommend that a 3 month gap be left between MMR vaccine and becoming pregnant but the UK and US advice is the most up to date and should be followed.
I AM TRYING FOR A BABY AND I DON'T KNOW IF I HAVE BEEN VACCINATED FOR RUBELLA. CAN I ASK MY GP OR CLINIC FOR A TEST?
Yes, you can ask your GP or clinic for a test to check your rubella antibodies before becoming pregnant. This is a wise move particularly if you can't remember if you've been vaccinated. But if you don't have rubella antibodies and need a dose of MMR, make sure that you avoid getting pregnant for one month after the jab.
I AM PREGNANT - IF MY 13 MONTH OLD CHILD HAS THE MMR VACCINE, AM I PUTTING MY BABY AT RISK FROM THE DISEASES FROM THE LIVE VACCINES?
It is not possible for anyone to catch any of the diseases that the vaccine protects against from a child recently immunised with MMR. So both you and your unborn baby are quite safe.
CAN BREAST-FEEDING WOMEN BE GIVEN MMR VACCINE?
MMR vaccine can be given to breast-feeding mothers without any risk to their baby. Very occasionally rubella vaccine virus has been found in breast milk but this has not caused any symptoms in the baby 7, 8, 9. The vaccine does not work when taken orally. There is no evidence of mumps and measles vaccine viruses being found in breast milk.
DOESN'T MMR VACCINATION CAUSE AUTISM?
There is no credible evidence of a link between MMR and autism - and there is an ever-increasing body of research which shows no evidence of a link.
The World Health Organisation describes MMR as a "highly effective vaccine which has an outstanding safety record".
CAN MMR VACCINE BE ADMINISTERED SIMULTANEOUSLY WITH ANTI-RHO (D) (ANTIBODY THAT IS GIVEN TO RHESUS NEGATIVE WOMEN) AFTER GIVING BIRTH?
Yes. It may be administered at the same time as rubella vaccine provided that separate syringes are used. The low dose of anti-Rho (D) globulin has been shown not to interfere with rubella vaccine, 10. Similarly as MMR is now the recommended vaccine the same advice applies, as issued by the Center for Disease Control (CDC) in February 2002, 11. If not given simultaneously, it should be given 3 months after anti-Rho (D).
HOW IS MMR VACCINE MADE?
MMR vaccine is made from live, but weakened measles, mumps and rubella viruses. The weakened viruses are grown either in chick embryo tissue cultures (mumps and measles) or in the human diploid cell line MRC-5 before being extensively purified, removing all traces of the cells. The viruses are then dried to a powder. The final product, in addition to the viruses, contains amino acids, human albumin, lactose, mannitol and sorbitol. It may also contain trace amounts of neomycin. The vaccine is suspended in sterile water before injection.
This article comes from the UK Department of Health
References
1 - Chu SY et al. Rubella antibody persistence after immunisation. JAVA 1988: 259; 3133-6
2 - O'Shea et al. Persistence of rubella antibody 8-18 years after vaccination. BMJ 1984:288; 1043
3 - Morse D et al. Outbreak of measles in a teenage school population: the need to immunise susceptible adolescents. Epidemiol Infect. 1994 Oct;113(2):355-65 Epidemiol Infect. 1994 ;113:355-65
4 - Fescharek R et al. Measles-mumps vaccination in the FRG: an empirical analysis after 14 years of use. Efficacy and analysis of vaccine failure. Vaccine 1990: 8; 333-6.
5 - Calvert et al. Commun Dis Rep CDR Rev. 1994 27;4(6):R70-3
6 - MMWR weekly December 14,2001/50(49); 1117
7 - Buimovici-Klein E et al, Isolation of rubella virus in milk after postpartum immunization. J Pediatr 91:939-943, 1977.
8 - Landes RD et al. Neonatal rubella following postpartum maternal immunisation. J Pediatr 97:465-467, 1980.
9 - Losonsky GA et al. Effect of immunization against rubella on lactation products. Development and characterization of specific immunologic reactivity in breast-milk J Infect Dis 145:654-660, 1982.
10 - Black et al. 1983. Post-partum rubella immunisation: a controlled trial of two vaccines. Lancet 29;2(8357);990-2). 11 - www.cdc.gov/nip/publications/pink/genrec.rtf
Label:
Pregnancy Latest News
Serono receives FDA approval for Gonal-f RFF Pen to treat infertility
First and only prefilled device with new liquid formulation developed to make infertility treatment more convenient for patients.
Serono, Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today that the United States Food and Drug Administration (FDA) has approved a prefilled device that delivers a new liquid formulation of the most prescribed gonadotropin in the world: Gonal-f RFF Pen (follitropin alfa injection).
Gonal-f RFF Pen is the first and only prefilled and ready-to-use multi-dose FSH (follicle stimulating hormone) in the US. It will be available in three sizes that deliver either 300 IU, 450 IU or 900 IU of liquid Gonal-f filled-by-mass, which can be administered in multiple doses. Developed to make infertility treatment easier, it provides patients with a new way to administer Gonal-f by simply dialing the correct dose without the need to mix medication or load cartridges. It was designed specifically for the treatment of infertility to allow patients to easily and accurately deliver a precise daily dose of medication.
"We are proud to be the first company to offer a prefilled and ready-to-use pen, providing a new option for infertility patients that is easy and simple to use, " said Bharat Tewarie, MD, Executive Vice President, Reproductive Health, Serono, Inc. "Serono is the world leader in reproductive health, and we are again demonstrating our commitment to continually improve the patient experience. Gonal-f RFF Pen, in addition to our multi-dose and single-dose vial presentations, gives us the most extensive and complete portfolio of infertility products to allow for enhanced dosing flexibility and individualized treatment." Serono expects Gonal-f RFF Pen to be available in the US in Q3 of this year.
Gonal-f RFF Pen is indicated for induction of ovulation and pregnancy in anovuluatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. It is also indicated for the development of multiple follicles in ovulatory women participating in an Assisted Reproductive Technology (ART) program.
Gonal-f is a highly consistent, filled-by-mass recombinant human follicle stimulating hormone (r-hFSH) prescribed to supplement or replace naturally occurring FSH, which stimulates the development of follicles in the ovaries. The Gonal-f prefilled pen was previously approved by the European Commission, the Swiss and the Australian Regulatory Authorities and launch is underway.
Infertility is defined as the inability to achieve pregnancy after one year of regular, unprotected intercourse (six months if the woman is over 35). It affects about 6.1 million Americans, which represents about 10 percent of couples in their childbearing years. About 70% of patients who are treated succeed in having children.
Additional Information
Side effects may occur with the use of infertility medications and, therefore, they should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Ovarian hyperstimulation syndrome (OHSS) with or without vascular and pulmonary complications, can occur with the use of infertility drugs. Reports of multiple births have been associated with gonadotropin treatment. Side effects in women using Gonal-f RFF Pen for infertility treatment may include headache, stomach pain, bloating, nausea and injection site bruising.
About Serono, Inc. and Infertility
Serono, Inc. is dedicated to providing patient-friendly, innovative products to help couples build families. It is the only company to offer a full portfolio of infertility medications for every stage of the reproductive cycle and recombinant versions of two hormones needed to treat infertility.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global biotechnology leader, headquartered in Geneva, Switzerland. Serono has seven recombinant products, Rebif (interferon beta-1a), Gonal-f (follitropin alfa for injection), Luveris (lutropin alfa), Ovidrel PreFilled Syringe/Ovitrelle (choriogonadotropin alfa injection), Serostim [somatropin (rDNA origin) for injection], Saizen [somatropin (rDNA origin) for injection] and Zorbtive? [somatropin (rDNA origin) for injection]. (Luveris is not approved in the USA.) In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. Serono's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net income of US$390.0 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2004. These factors include any failure or delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. Serono has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
Contact: Aimee White
aimee.white@edelman.com
212-642-7767
Edelman Public Relations
View drug information on Ovidrel.
Source: medicalnewstoday.com
Serono, Inc., the US affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today that the United States Food and Drug Administration (FDA) has approved a prefilled device that delivers a new liquid formulation of the most prescribed gonadotropin in the world: Gonal-f RFF Pen (follitropin alfa injection).
Gonal-f RFF Pen is the first and only prefilled and ready-to-use multi-dose FSH (follicle stimulating hormone) in the US. It will be available in three sizes that deliver either 300 IU, 450 IU or 900 IU of liquid Gonal-f filled-by-mass, which can be administered in multiple doses. Developed to make infertility treatment easier, it provides patients with a new way to administer Gonal-f by simply dialing the correct dose without the need to mix medication or load cartridges. It was designed specifically for the treatment of infertility to allow patients to easily and accurately deliver a precise daily dose of medication.
"We are proud to be the first company to offer a prefilled and ready-to-use pen, providing a new option for infertility patients that is easy and simple to use, " said Bharat Tewarie, MD, Executive Vice President, Reproductive Health, Serono, Inc. "Serono is the world leader in reproductive health, and we are again demonstrating our commitment to continually improve the patient experience. Gonal-f RFF Pen, in addition to our multi-dose and single-dose vial presentations, gives us the most extensive and complete portfolio of infertility products to allow for enhanced dosing flexibility and individualized treatment." Serono expects Gonal-f RFF Pen to be available in the US in Q3 of this year.
Gonal-f RFF Pen is indicated for induction of ovulation and pregnancy in anovuluatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. It is also indicated for the development of multiple follicles in ovulatory women participating in an Assisted Reproductive Technology (ART) program.
Gonal-f is a highly consistent, filled-by-mass recombinant human follicle stimulating hormone (r-hFSH) prescribed to supplement or replace naturally occurring FSH, which stimulates the development of follicles in the ovaries. The Gonal-f prefilled pen was previously approved by the European Commission, the Swiss and the Australian Regulatory Authorities and launch is underway.
Infertility is defined as the inability to achieve pregnancy after one year of regular, unprotected intercourse (six months if the woman is over 35). It affects about 6.1 million Americans, which represents about 10 percent of couples in their childbearing years. About 70% of patients who are treated succeed in having children.
Additional Information
Side effects may occur with the use of infertility medications and, therefore, they should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Ovarian hyperstimulation syndrome (OHSS) with or without vascular and pulmonary complications, can occur with the use of infertility drugs. Reports of multiple births have been associated with gonadotropin treatment. Side effects in women using Gonal-f RFF Pen for infertility treatment may include headache, stomach pain, bloating, nausea and injection site bruising.
About Serono, Inc. and Infertility
Serono, Inc. is dedicated to providing patient-friendly, innovative products to help couples build families. It is the only company to offer a full portfolio of infertility medications for every stage of the reproductive cycle and recombinant versions of two hormones needed to treat infertility.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global biotechnology leader, headquartered in Geneva, Switzerland. Serono has seven recombinant products, Rebif (interferon beta-1a), Gonal-f (follitropin alfa for injection), Luveris (lutropin alfa), Ovidrel PreFilled Syringe/Ovitrelle (choriogonadotropin alfa injection), Serostim [somatropin (rDNA origin) for injection], Saizen [somatropin (rDNA origin) for injection] and Zorbtive? [somatropin (rDNA origin) for injection]. (Luveris is not approved in the USA.) In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. Serono's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net income of US$390.0 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2004. These factors include any failure or delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. Serono has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
Contact: Aimee White
aimee.white@edelman.com
212-642-7767
Edelman Public Relations
View drug information on Ovidrel.
Source: medicalnewstoday.com
Label:
Pregnancy Latest News
Subscribe to:
Posts (Atom)