MUMBAI: The Food and Drug Administration (FDA) has banned the use of weight-loss pill “rimonabant” after research showed that the drug caused serious psychiatric side-effects, including suicidal tendencies among users. About 12 generic companies in India manufacture the anti-obesity drug, which had a tiny, Rs 13-crore market.

The office of the Central Drugs Standard Control Organisation of the ministry of health and family welfare asked the companies to stop manufacturing the drug and recall the available products in the market. The need to ban the drug was also raised at a recent meeting of the Drug Coordination Committee and the Drug Technical Advisory Body, though no drastic side-effects of the drug were reported in the country. (more…)

The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CMHP) has today recommended the suspension of the Marketing Authorisation for Acomplia because the benefits no longer outweigh the risks.

The most recent assessment by the CHMP looked at the available data for the benefits and risks associated with Acomplia (rimonabant), including studies that have been completed since its approval. The analysis showed that there was approximately a doubling of the risk of psychiatric disorders in obese or overweight patients taking Acomplia compared to those taking a placebo (a dummy pill). (more…)