Letrozole, an anticancer drug being promoted in brand names including Letrox in India to treat infertility in women, could phase prohibition to the indication, reports said.
Letrozole is a drug generally used to treat breast cancer in various markets across the world, including India.
However, letrozole is not used as treatment for fertility problems in young women anywhere else in the world except India, reports said quoting experts.
Novartis, the original innovator of the letrozole and various leading regulatory agencies in the world including Canadian health regulator have issued warnings against the use of letrozole to treat infertility because it can cause serious and irreversible adverse effects in patients.
If used in pregnancy letrozole can cause serious side effects to an unborn child.
Novartis markets letrozole in the brand name Femara by Novartis. Letrozole is an oral, anti-estrogen drug that is used for treating postmenopausal women with breast cancer.
The growth of some breast cancers in postmenopausal women is promoted by estrogens that circulate in the blood, and the adrenal glands are the main source of these circulating estrogens.
Letrozole inhibits the enzyme in the adrenal glands (aromatase) that produces the estrogens, estradiol and estrone.
Letrozole (Femara) was approved by US FDA in 1997.
Letrox, promoted by Sun Pharma, is the only brand name drug to treat infertility in young women in India, according to the drug controller general of India (DCGI) Surinder Singh.
DCGI has recently stated that India’s top regulatory body will review the post-marketing surveillance data on letrozole (Letrox) from Sun Pharma as well as the clinical trials report of breast cancer medicine.
Letrox (chemical name letrozole) to decide whether the drug should be banned from being marketed, as an anti-infertility drug to induce ovulation among young women.
The post-marketing surveillance data is the information regarding the safety of a drug after it reached the markets for sale.
Drug Technical Advisory Board (DTAB), which advises the drug regulator on technical matters would examine the post-marketing surveillance data on letrozole (Letrox) soon.
IF DTAB finds a higher risk in the use of letrozole (Letrox) as an infertility medicine, the DCGI may ban the drug from being marketed as an infertility drug, the reports said.
Letrozole is being promoted as an infertility treatment by other companies including Fresenius Kabi and Dr Reddy’s, reports said.
In December, India imposed a ban on the sales of rimonabant, the controversial weight-loss drug in Acomplia implicated in several serious side-effects and psychiatric problems including suicide ideation, has been finally banned in India.
Department of Health under the Ministry of Health and Family Welfare, Government of India issued a notification dated 11th December announcing the official prohibition on manufacture sale and distribution of the drug in India. See our last story Weight loss drug Rimonabant faces ban in India
The Central government has also prohibited the import of rimonabant into India.
Rimonabant is likely to involve certain risk to human beings, the notification said.
The miracle weight loss drug Rimonabant is already banned in several developed countries. This slimming medicine is found to create side-effects of suicidal tendencies in those who consume it.
Rimonabant, sold under a dozen brand names in India, has already disappeared from chemist shops abroad. However, in India, it is still available at drug shops under different names, shapes and colours.
Indian drug manufacturers including Ranbaxy, Sun, Zydus and Torrent Pharma have been advertising and marketing the prescription weight loss drug Rimonabant in India. This is despite the fact being a prescription drug, Rimonabant is to be sold under only under a doctor’s prescription and not advertised in the media. Only OTC (over the counter) drugs are allowed to be advertised and promoted in India.