Pills you pop in in the hope of slimming down might just force you into depression. Worse, they might even lead you to commit suicide.
MUMBAI: Pills you pop in in the hope of slimming down might just force you into depression. Worse, they might even lead you to commit suicide.
A recent study in UK’s premier medical journal, The Lancet, says four slimming drugs sold in the market put patients at risk of severe psychiatric side effects. The drug, known as Rimonabant, is branded and sold as Acomplia by its inventor Sanofi-Aventis.
In India, copycat versions of the drug are made by Torrent Pharmaceuticals (called Remoslim), Zydus Cadila (Slimona) and Sun Pharmaceuticals (Riocity and Riobec). Rimonabant is approved in 52 countries and sold in 21. But the US Food and Drug Administration has rejected it on concerns it could increase suicidal thinking and depression.
Torrent and Zydus Cadila did not reply to an email sent by DNA seeking clarity on why the drug was being sold despite its known side effects.
Sun Pharmaceuticals countered that the drug has received approvals and is sold by its innovator, Sanofi Aventis, in most of Europe. “Also, we have conducted the safety trials that regulator requires for registering a product in the country under the drug laws. The results were submitted to the regulatory authority and then we got an approval,” Sun said. The company, though, declined to share any data.
Shashank R Joshi, endocrinologist at the Lilavati Hospital, said the biggest problem is that pharmaceutical companies promote the drug through general physicians. “Any doctor can prescribe this. Individuals can easily buy it from any medical store. This is a specialised drug and needs to be recommended by an endocrinologist.”
Lancet says such drugs put patients at risk of severe psychiatric side effects. Indian pharma firms sell four such brands...
Joshi says all patients cannot take the drug. “Patients need to undergo psychiatric tests first to determine whether they could be put on the medication. It also requires a good deal of pharmacovigilance.”
Joshi was involved in the safety tests of a slimming drug for a domestic pharmaceutical company, details of which he did not reveal citing confidentiality clauses.
Sanofi-Aventis issued a statement following The Lancet study. It said: “The company has learned about the content of meta-analyses published in The Lancet and the British Medical Journal on November 16, 2007. The clinical data resulting from these meta-analyses do not add any new information and are in line with the clinical trials on efficacy and safety known with rimonabant today.”
Meanwhile, domestic drugmakers have set ambitious sales targets for the drug. Torrent Pharma reportedly aims to sell 1.25 crore strips this year. It has priced the drug at Rs 8 per strip and expects to clock Rs 10 crore in sales. Zydus Cadila, on the other hand, plans to launch it in other countries where the laws or patent regulations permit.
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