A widely used anti-obesity drug, Sibutramine, has come under the US regulatory body Food and Drug Administration (FDA) scanner while the European Medicines Evaluation Agency (EMEA) has already barred its usage with recommendations that doctors stop prescribing the drug and pharmacists told not to dispense it.
The FDA has suggested that patients with a history of high-risk diseases should avoid its use.
The drug has been in wide use in India since 1999 and after the warning, the Drug Controller General of India (DCGI) has decided to refer the matter to an expert group.
The DCGI, Surinder Singh told the Indian Express that if experts see a problem in the drug, the manufacturers would immediately told to stop its production.
According to the FDA the warning is based on the results of a study conducted on 10,000 patients. According to a preliminary analysis, patients using sibutramine experience a higher number of cardiovascular events.
Source : http://www.domain-b.com/industry/pharma/20100125_obesity_drug.html
The FDA has suggested that patients with a history of high-risk diseases should avoid its use.
The drug has been in wide use in India since 1999 and after the warning, the Drug Controller General of India (DCGI) has decided to refer the matter to an expert group.
The DCGI, Surinder Singh told the Indian Express that if experts see a problem in the drug, the manufacturers would immediately told to stop its production.
According to the FDA the warning is based on the results of a study conducted on 10,000 patients. According to a preliminary analysis, patients using sibutramine experience a higher number of cardiovascular events.
Source : http://www.domain-b.com/industry/pharma/20100125_obesity_drug.html
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