Conclusion: There was no difference in the overall rates of major and minor congenital malformations among newborns from mothers who conceived after letrozole or CC treatments. However, it appears that congenital cardiac anomaly is less frequent in the letrozole group. The concern that letrozole use for ovulation induction could be teratogenic is unfounded based on our data. (Fertil Steril 2006;85:1761–5. ©2006 by American Society for Reproductive Medicine.)
Finally, expert panel bans fertility drug Letrozole
NEW DELHI: India has banned manufacture, sale and distribution of controversial drug Letrozole.
Though globally the drug is used for treatment of breast cancer, in India it was being administered to young infertile women to help them conceive.
A 16-member committee, under special director general of health services Dr D C Jain, decided to ban the drug.
The Union health ministry's notification on Monday said, "In exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940, the Central government has suspended the manufacture for sale, sale and distribution of Letrozole for induction of ovulation in anovulatory infertility with immediate effect. The Central government is satisfied that it is necessary and expedient to regulate by way of suspension of manufacture, sale and distribution of the drug for the said indication in the public interest."
It added, "The Central government is satisfied that the use of the drug for induction of ovulation in an ovulatory infertility is likely to involve risk to human beings and safer alternatives to the said drugs are available."
Over the years, there has been a growing suspicion that the drug's side-effects have led to severe genetic abnormalities among babies born to infertile women.
Dr Chandra M Gulhati, editor of Monthly Index of Medical Specialties, India, a journal on drugs, said, "Letrozole sold under various brand names in India such as Letroz and Letoval is internationally approved for treatment of breast cancer in post-menopausal women. Both, the Canadian drug regulator and the innovator company Novartis have warned gynecologists not to misuse it for female infertility. Research on 150 pregnancies has shown that babies born to mothers who had consumed Letrozole to increase fertility have suffered from bone malformations, cardiac stenosis and cancers."
Dr Gulhati added that Letrozole has a Rs-37 crore market in India, which is growing at 35% annually. Brands like Letroz and Letoval, made by Sun Pharma, are in great demand. While, minor players are Oreta (Dr Reddys), Letz (Chemech) and Shantroz (Shantha Biotech).
Ministry sources said the committee that took the decision included gynecologists, reproductive biologists, pharmacologists and research experts.
Dr Gulhati said "It is no more the first drug of choice for breast cancer as several new ones are now available. But, it still has a big market. This clearly shows how Letrozole's use for inducing ovulation is still rampant in India."
Though globally the drug is used for treatment of breast cancer, in India it was being administered to young infertile women to help them conceive.
A 16-member committee, under special director general of health services Dr D C Jain, decided to ban the drug.
The Union health ministry's notification on Monday said, "In exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940, the Central government has suspended the manufacture for sale, sale and distribution of Letrozole for induction of ovulation in anovulatory infertility with immediate effect. The Central government is satisfied that it is necessary and expedient to regulate by way of suspension of manufacture, sale and distribution of the drug for the said indication in the public interest."
It added, "The Central government is satisfied that the use of the drug for induction of ovulation in an ovulatory infertility is likely to involve risk to human beings and safer alternatives to the said drugs are available."
Over the years, there has been a growing suspicion that the drug's side-effects have led to severe genetic abnormalities among babies born to infertile women.
Dr Chandra M Gulhati, editor of Monthly Index of Medical Specialties, India, a journal on drugs, said, "Letrozole sold under various brand names in India such as Letroz and Letoval is internationally approved for treatment of breast cancer in post-menopausal women. Both, the Canadian drug regulator and the innovator company Novartis have warned gynecologists not to misuse it for female infertility. Research on 150 pregnancies has shown that babies born to mothers who had consumed Letrozole to increase fertility have suffered from bone malformations, cardiac stenosis and cancers."
Dr Gulhati added that Letrozole has a Rs-37 crore market in India, which is growing at 35% annually. Brands like Letroz and Letoval, made by Sun Pharma, are in great demand. While, minor players are Oreta (Dr Reddys), Letz (Chemech) and Shantroz (Shantha Biotech).
Ministry sources said the committee that took the decision included gynecologists, reproductive biologists, pharmacologists and research experts.
Dr Gulhati said "It is no more the first drug of choice for breast cancer as several new ones are now available. But, it still has a big market. This clearly shows how Letrozole's use for inducing ovulation is still rampant in India."
Edmonton Journal (Alberta)
November 30, 2005 Wednesday
Final Edition
Cancer drug linked to birth defects: Doctors warned to stop using Femara for infertility
BYLINE: Sharon Kirkey, CanWest News Service
SECTION: BODZ & HEALTH; Pg. A17
LENGTH: 510 words
Canadian doctors are being told to stop using a breast-cancer drug to help infertile women get pregnant because it could cause birth defects.
Femara is being used to induce ovulation in infertile women, even though the labelling and prescribing information clearly shows it should not be used in women who may become pregnant because of the potential risk to the mother and fetus.
But the pills were rushed to infertility clinics two years ago after reports showed Femara was better than some older fertility drugs at stimulating a woman's body to release eggs.
A study of 150 babies born to women who were treated with Femara at a Montreal fertility centre found a higher incidence of loco-motor malformations -- such as problems crawling or walking -- and heart anomolies compared to "normal" deliveries.
The study, which involved babies born at Montreal's St. Mary's Hospital between 1995 and 2004, was presented at a recent meeting of American and Canadian fertility specialists. The Montreal doctors concluded use of Femara to treat infertility "should be controlled until more data on the outcomes of pregnancies is obtained."
A leading Canadian fertility doctor said it's not clear if Femara caused the birth defects, or whether they were due to the underlying condition.
The drug has never been properly tested for wide-scale use as a fertility drug, said Dr. Roger Pierson, past president of the Canadian Fertility and Andrology Society and chair of its communications committee.
"What you don't want is everybody and their fellow doctor running out and doing this in an uncontrolled fashion."
In the 12-month period ending Oct. 31, 85,733 prescriptions for Femara were filled in Canadian retail drugs stores, according to IMS Health, which tracks prescription drug sales in Canada.
The drug's manufacturer and Health Canada have issued a "dear health care professional" letter reminding doctors Femara has not been approved for ovulation induction. The drug has been approved to treat advanced breast cancer in postmenopausal women.
"Novartis is aware that Femara (chemical name, letrozole) has been or is being used to treat infertility even though statements in the Canadian Product Monographs warn physicians about potential embryo- and fetotoxicity with or without teratogenicity" -- meaning the ability to cause birth defects, Novartis Pharmaceuticals Canada Inc. said in the letter sent to Canadian gynecologists, obstetricians and infertility specialists.
According to Health Canada, there have been international reports of 13 women exposed to the drug while pregnant. Four involved "adverse outcomes" for the babies.
Three of the cases involved the "off label" use of Femara for infertility. Two of the women had spontaneous abortions and the third woman's baby was diagnosed with a type of cancer at one year of age.
In the fourth case, a baby girl of a woman who was treated with Femara for breast cancer while she was pregnant was born with a genital abnormality.
Novartis says any woman who becomes pregnant after taking the drug should contact her doctor.
LANGUAGE: ENGLISH
- A randomized single-blind controlled trial of letrozole as a low-cost IVF protocol in women with poor ovarian response: a preliminary report
- Hum Reprod, 19 (2004), pp. 2031–2035
Abstract
Background: Use of letrozole, a selective inhibitor of aromatase, reduces the gonadotrophin dose required to induce follicular maturation. We evaluated whether incorporation of letrozole could be an effective low-cost IVF protocol for poor responders. Methods: A randomized, controlled, single-blind trial was conducted in the Assisted Reproduction Unit, Institute of Reproductive Medicine, Kolkata, India. Thirty-eight women with a history of poor ovarian response to gonadotrophins were recruited. Thirteen women (Let-FSH group) received letrozole 2.5 mg daily from day 3-7, and recombinant FSH (rFSH) 75 IU/day on days 3 and 8; and 25 women (GnRH-ag-FSH group) underwent long GnRH agonist protocol and stimulated with rFSH (300-450 IU/day). Ovulation was triggered by 10 000 IU of HCG followed by IVF-embryo transfer. The main outcome measures were total dose of rFSH (IU/cycle), terminal estradiol (E2) (pg/ml), numbers of follicles, oocytes retrieved and transferable embryo, endometrial thickness (mm), and pregnancy rate. Results: Compared with the GnRH-ag-FSH group (2865 ± 228 IU), the Let-FSH group (150 ± 0 IU) received a significantly (P < 0.001) lower total dose of FSH. Except for terminal E2, which was significantly higher (P < 0.001) in the GnRH-ag-FSH group (380 ± 46 pg/ml) than the Let-FSH group (227 ± 45 pg/ml), the treatment outcomes in all other respects, including pregnancy rate, were statistically comparable. Conclusions: Adjunctive use of letrozole may form an effective means of low-cost IVF protocol in poorly responding women. © European Society of Human Reproduction and Embryology 2004; all rights reserved.
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