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This is an archive article published on January 25, 2010

FDA warning on widely used drug against obesity

A widely known anti-obesity drug,Sibutramine,has come under the scanner of the US regulatory body,Food and Drug Administration....

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A widely known anti-obesity drug,Sibutramine,has come under the scanner of the US regulatory body,Food and Drug Administration (FDA),which has suggested that patients with a history of high-risk diseases should avoid it.

The European Medicines Evaluation Agency (EMEA) has already suspended its usage,recommending that doctors no longer prescribe and pharmacists no longer dispense the drug,which is marketed in Australia as Ectiva or Reductil.

While the drug has been widely used in India since 1999,after the warning,the Drug Controller General of India (DCGI) has decided to take the matter to an expert group. “If experts see a problem in the drug,the manufacturers would be asked to immediately stop its production,” DCGI Surinder Singh told The Indian Express.

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According to the FDA,the warnings are based on the results of a study done on 10,000 patients. A preliminary analysis suggests patients using sibutramine experience a higher number of cardiovascular events. The drug is widely recommended for patients who do not respond to a strict diet regime.

The FDA has suggested that sibutramine be avoided in patients with a history of coronary artery disease (heart disease),congestive heart failure (CHF),arrhythmias,or stroke. The FDA has also asked healthcare professionals to continue evaluating the benefits and risks of weigh loss pills,taking into account individual patient medical histories.

Doctors say there is need to be cautious. “According to national guidelines of treatment of obesity,the drug is number 1,” Dr Anoop Misra,Director and Head,Department of Diabetes & Metabolic Diseases,Fortis Hospitals,said.

“The average weight loss with sibutramine over six months is 7-8 kg. There is need to keep an eye as we recommend it all the time even to young obese,” Dr Mishra added. However,he added,while the warning should be kept in mind,“I don’t think we should relinquish using this drug.”

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Till date no adverse effects have been seen in patients taking the drug in India,according to doctors.

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