Five years after suspending the manufacture, sale and distribution of controversial drug letrozole, citing side-effects, the Union Health Ministry’s highest decision-making technical body on drugs has recommended lifting the restrictions and allowing the medicine to be used for administering in young infertile women to help them conceive.
The move followed recommendation by a scientific panel of the Indian Council for Medical Research (ICMR), which after conducting a detailed science-based study found that the drug had more benefits for the infertile women than side-effects.
‘We have sent the recommendation of the Drugs Technical Advisory Board’s (DTAB) on letrozole to the Union Health Ministry to take a final call. Union law Ministry will also give its opinion,’ said Director General of Controller of India (DCGI) GN Singh, who was also part of the Board.
Currently, letrozole is used as a treatment for breast cancer in women who have gone through menopause. Till 2011, gynaecologists had been using it as a fertility drug too for infertile women to help them ovulate and conceive a child.
‘In view of the report of the expert committee of the ICMR expert committee forwarded by the Secretary, Department of Health Research, Ministry of Health and Family Welfare and Director General, ICMR, DTAB recommended that the notification under Section 26A for suspension of manufacture and sale of the drug letrozole for induction of ovulation in anovulatory infertility may be revoked,’ said the Board in a meeting held early this month.
Gynaecologists have welcomed the move calling the drug as a ‘boon’ for the infertile married women.
Dr Rita Bakshi, fertility expert, gynaecologist and Chairperson, International Fertility Centre in Delhi, welcomed the move saying that much before its ban, almost all gynaecologists had been using it in the cases where the routine drug Clomiphene failed to respond. She said that the drug helped reduce the estrogen level and boost egg growth. There were some cases of breast pain and backache following which its sale was suspended.
Echoing similar views, senior consultant and gynaecologist at Delhi-based Fortis la Femme, Dr Madhu Goel termed letrozole as a 'wonder drug' for infertile women. On the side-effects of the drugs which resulted its restricted sale in 2011, Dr Goel maintained that almost all allopathic drugs have side effects and it has to be seen how serious they are.
The experts said that some 10 per cent to 20 per cent of women taking Clomiphene or letrozole experience side effects. ‘By far, most of these are minor and temporary in nature. They include hot flashes, blurred vision, nausea, bloating sensation, and headache. Serious side effects are rarely seen with either medication,’ they added.
A large study from a research network supported by the National Institutes of Health said, the drug letrozole appears to be more effective than the standard drug Clomiphene for helping women with polycystic ovary syndrome (PCOS) to achieve pregnancy. The study appeared in the New England Journal of Medicine in 2014.