Sales of weight loss pill sibutramine could be prohibited in India

The controversial anti-obesity drug sibutramine could be banned in India, reports said. Studies have found that sibutramine increase the risk of heart attack, stroke and death, in patients consuming the drug as an aid to shed their excess flab. European Medicine Agency (EMA) has been recommended complete withdrawal of sibutramine from European markets.

Sibutramine which is being sold under the brand name Meridia by Abbott is being used by roughly a quarter million people to lose weight in US. Sibutramine, available in India since 1999, is one of the most commonly prescribed medicines sold in the Rs 200-crore (Rs 2 billion) anti-obesity market of the country. In India sibutramine is manufactured and marketed by nearly two dozen generic companies under various brand names.

Apart from Abbot, Cipla (brand name Obestat), Sun, Glenmark, Torrent, Mankind, Micro Labs sell their own versions of sibutramine in India.

In view of latest studies suggesting higher risk of heart diseases, India’s top drug regulator, Drugs Controller General of India has already alerted the members of its pharmacovigilance committee to independendly assess the safety profile of sibutramine in Indian population.

Indian Pharmacovigilance Committee would submit thier find-making body on drug safety to the Drugs Technical Advisory Board -the committee that advises DCGI on technical matters. Ban would be brought into effect if DTAB recommends it. Preliminary results from a recent study involving 10,000 patients showed a slightly higher risk of heart-related problems in patients taking Meridia compared with a dummy pill.

The study group consisted patients older than 55, overweight with a history of heart disease or diabetes. On the basis of this study, a consumer advocacy group Public Citizen has petitioned the government and the US Food and Drug Administration to ban the weight loss pill Meridia.

The only appropriate US FDA action to protect the public health was to immediate remove Meridia from the market since the science behind the results seen in this study would mandate nothing less than that, the petition said. A total of 84 deaths were associated with Meridia as of June since US FDA approved the drug in 1997 as a weight loss aid together with diet and exercise. However, US FDA was making no conclusions about the preliminary findings, the agancy clarified on release of the data last month. US FDA’s panel of outside specialists voted out 5 to 4 for sibutramine (Meridia) as they found the drug’s risks outweighed its benefits, the Public Citizen group’s petition pointed out. US FDA had rejected a similar petition from Public Citizen in 2005 seeking withdrawal of  Meridia, suggesting that wanted to wait for the findings of the 10,000-patient study.

Abbott lauched a study to analyze the risk of cardiovascular-related problems of Meridia (sibutramine hydrochloride monohydrate) in 2003 at the request of European regulators. Abbott’s Meridia (sibutramine hydrochloride monohydrate), study involved high-risk patients with a history of cardiovascular problems. In December last year, DCGI banned rimonabant, a controversial weight-loss drug in Acomplia implicated in several serious side-effects and psychiatric problems including suicide ideation. 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. 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.

What is sibutramine?

Sibutramine is a centrally acting stimulant chemically related to amphetamines. Sibutramine is classified as a Schedule IV controlled substance in the United States. Sibutramine acts by increasing serotonin and norepinephrine levels in the brain. Sibutramine’s serotonergic action is thought to influence appetite.

Sibutramine is a neurotransmitter reuptake inhibitor that helps enhance satiety by inhibiting the reuptake of serotonin (by 53%), norepinephrine (by 54%), and dopamine (by 16%). Sibutramine may cause side effects including: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, anorgasmia and delayed ejaculation, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.