India bans import and sale of weight loss pill rimonabant

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.

Suicidal tendencies are a critical side-effect of the Rimonabant slimming drug. Taking note of the danger, India’s top drug advisory body, Drug Technical Advisory Board (DTAB), has reportedly recommended to the Health Ministry to initiate a ban on the production and selling of Rimonabant in India. The advisory board is believed to have recommended the ban as “a precautionary measure, after it was stopped in European nations.” DTAB provides guidelines to the drug regulator on the risk-benefit profiles of drugs to be sold in India.

The weight loss pill Rimonabant was originally developed by the European drug giant Sanofi-Aventis under the brand name Acomplia. Rimonabant is also sold under brand names Slimona, Monaslim, Bethin, Riobant, Rimoslim and Zimulti.

The pill has lately been found responsible for causing serious depression, anxiety and stress disorders in patients using it. An FDA meta-analysis of Rimonabant’s drug safety data has indicated an increased risk (side-effects) of suicidal ideation in patients on the highest 2 mg drug dose: two suicides were recorded across the Rimonabant clinical trial programme, one of which occurred in the RIO-North America trial.

On Rimonabant’s side-effects, the US drug regulator committee also expressed concerns about an increased risk of other psychiatric adverse events and adverse neurological events including seizure with Rimonabant 20mg, while noting the high numbers of patients who withdrew prematurely from the RIO trials during the first year of treatment. In Europe, the EMEA has now taken a similar view.

Sanofi-Aventis itself has stopped promoting the slimming pill Rimonabant to other countries after it failed to secure marketing approval from US FDA in 2007.

Rimonabant is a selective CB1 endocannabinoid receptor antagonist indicated for the treatment of obesity. It works by blocking endogenous cannabinoid binding to neuronal CB1 receptors. Activation of these receptors by endogenous cannabinoids, such as anadamide, increases appetite. Serotonin and noradrenaline reuptake inhibitors (anorectic agents),lipase inhibitors

ß 3-adrenoreceptor agonists, leptin agonists, melanocortin-3 agonists are some of the other therapeutic approaches to obesity. Rimonabant was developed differently from these known approaches, from the knowledge that cannabis smokers often experience extreme hunger pangs, and that if cannabinoids stimulate appetite, blocking cannabinoid receptors in the brain might reduce appetite.

Although available in Europe since 2006 for use as an adjunct to diet and exercise for obese or overweight patients with associated risk factors, concerns over the slimming pill Rimonabant have been growing that patients taking Acomplia were at increased risk of psychiatric adverse events, including suicidality.

Data had shown rimonabant doubles of the risk of psychiatric disorders in patients taking the drug. The European Medicines Agency, after its study, has also revealed that overweight or obese people who had been treated with slimming pill Acomplia were at double the risk of suffering from psychiatric problems than a group of patients who had been given a placebo instead for their condition in October 2008, following a review of post-marketing data, the EMEA recommended suspension of Rimonabant’s marketing authorisation on safety grounds.

Obesity, now the most common nutritional disorder in western industrialised countries, is increasingly emerging as a health problem in India too with the swell of the growing middle-class and urban rich. Obesity is defined as a body mass index of greater than 30, it arises from the accumulation of excess fat in the body from over consumption of fatty foods.

With the rise of obesity, a large number of online sellers of weight loss drugs have sprung up in the last few years, selling pills and medicines on the internet to lose weight. Several drugs and medications are available online, but it is strictly recommended that before buying and using online weight loss medication, one must consult a qualified physician.