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Monday, October 24, 2011

Letrozole banned in India for its use to treat infertility as ovulation inducer.

Why and for which indication drug letrozole is bannned in India

The drug letrozole is now banned in India by Indian ministry of health and family welfare for its use to treat infertility in women as it may cause teratogenic effects like defective bone formations, cardiac stenosis and even cancer too, to babies born to mothers who used drug letrozole .

Drug letrozole was approved in India for use as ovulation inducer in women with anovulatory infertility and it is now banned for manufacture for sale, or sale or distribution for indication anovulatory infertility. An official notification with this regard was published in The Gazette of India on 12th of oct 20011

The drug letrozole is banned for its use as ovulation inducer as the drug letrozole has teratogenic effect and may cause defects in babies born to mothers taking drug letrozole. In a clinical trial it was found that the baby born to mothers who had consumed letrozole for treating their infertility have developed bone malformation, cancer and cardiac stenosis.

Letrozole’s use in treatment of breast cancer:
In US the drug letrozole is approved only to treat non metastatic as well as metastatic breast cancer. Breast cancer cells when dislodge form the its origin and when mobilize or spread to other tissue is called as metastatic, and these cancer cells growth is fasten or depends on stimulation from hormone estrogens the female sex hormones.

Estrogens are synthesized in human body from androgens after action of enzyme aromatase.The drug Letrozole competitively blocks enzyme aromatase, thereby blocking the symntesis of estrogens which prevent breast cancer cell from multiplication and further growth.

Though the drug Letrozole is a choice of drug for the indication for breast cancer it has some serious side effects like osteoporosis (loss of bone mass because of which bones become fragile and get fractured more often) and hypoestrogenism, therefore to counter act osteoporosis after use of Letrozole drug like Bisphosphonates are always priscribe along with Letrozole. The drug letrozole is also used off the label by some to counteract gynecomastia induced by anabolic steroids. Now letrozole is banned in India for use as ovulation inducer in women with anovulatory infertility.


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