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Justifying the use of letrozole for inducing ovulation

Letrozole used for the treatment of advanced/metastatic breast cancer in postmenopausal women is also being used by // infertility specialists as a second line of treatment for infertility for inducing ovulation. Studies indicate that letrozole was used not on an experimental basis, but as an accepted safe drug for inducing ovulation.

However some feel that without clinical trials to ascertain any possible side effect, prescribing the drug Letrozole for infertility is unethical and illegal. Another argument is that, since the drug is used for a short duration of 5 days its effect is short acting and the side effects would be minimum or practically nil. It is also said that since the drug is administered before ovulation and fertilization, there is no question of teratogenicity (malformation of the fetus) when compared to injectible gonado tropins used for treating infertility which are associated with a higher incidence of multiple pregnancies.

It is argued that the practice of medicine is regulated by Medical Council of India, and not by the Drugs Controller hence they feel that drug controller can introduce a new drug for marketing, or ban a particular drug from being sold but should not be given the right to designate a particular drug for a particular disease, to be prescribed by a particular section of doctors.

Letrozole could be prescribed only for treating breast cancer and not for inducing ovulation as per the permission given by the Drugs Controller General of India (DCGI). However it is said that doctors cannot be asked not to prescribe it , instead ask the drug store owners not to honor any prescriptions violating existing norms stipulated by the Drugs Controller's office.

A doctor specializing in oncology and women's diseases from a city based hospital 'A cure for incurable ‘, says that the use of letrozole in a healthy women if used for ovulation may lead to developing cancer of ovary, breast or any other
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