Posted by Neharika Sabharwal on November 28, 2010

The decision to pull sibutramine off the shelves was taken by India’s top drug regulator, Drugs Controller General of India (DCGI) following a safety review which concluded that the risk of heart attacks, strokes and even death arising from the use of the popular weight-loss pill was far greater than its potential benefits.

Dr YK Gupta, head of the department, pharmacology, AIIMS, who's a member of Indian Pharmacovigilance Committee stated, "There is a need to evaluate the benefit-risk ratio. Since it is not a life-saving drug, it can be banned.

"In the presence of several other effective and safer methods of weight loss, the risk posed by this drug cannot be ignored for its benefits.”

Pharmacists unaware of the ban
Sibutramine, introduced to the Indian market in 1999 was sold in the country by a dozen companies under brand names such as Reductil, Meridia, and Sibutrex.

The sale of the sibutramine was sharp till January this year but after the European Medicines Agency (EMEA) suggested that doctors cease recommending the anti-obesity drug Sibutramine and pharmacists refrain from selling it, the sales dropped.

The drug is popular amidst youngsters, housewives who are more open to diet suppressants without even consulting the doctors.

The urge to lose weight instantaneously has prompted many to look for such drugs online and buy them from their local drugstore.

While the ban seems to be in place, many pharmacies in Yusuf Sarai market in Delhi are still marketing the pill.

Rippon Nath, owner of Nath Brothers chemist store stated, "Since January, its sales have gone down. It is widely prescribed by doctors. It is one of the fastest selling anti-obesity pill in the city.

He added, "We are not aware about the ban. There is huge demand for the drug. The drug is very effective. Instead of banning the drug, the government should put it in the special category so that it can be given to those who really need it."

Concerns of serious health risks prompts ban
Following an assessment of the safety and efficacy of sibutramine, the DCGI on November 12 suspended the manufacturing and imports of the drug due to its associated risk of cardiovascular events such as heart attacks and stroke.

Dr Anoop Misra, director and head of the department diabetes and metabolic diseases, Fortis healthcare stated, "It is very effective in reducing weight. But we have to see the side effects.

"Several trials have indicated that it results in increased heart problems. One of the biggest trials on the drug in Europe showed that sibutramine increased the risk of heart problems by 16%.”




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