03 July 2010
By Eena Thacker
New Delhi, India
Following a recent study by the Journal of American Medical Association (JAMA), stating that anti–diabetic drug Rosiglitazone may be associated with an increased risk of life–threatening diseases, the Drug Controller General of India (DCGI) on Friday put on hold the clinical trails of the drug going on at 10 centres in the country.
According to the JAMA article, Rosilitazone was found to be associated with an increased risk of stroke and heart failure in patients 65 years and older.
Known to be providing effective blood glucose control, the drug has come under the scanner many a times earlier.
The American Diabetes Association and the European Diabetes Association had, in fact, jointly advised against the use of Rosiglitazone.
The DCGI is waiting for the US FDA report on the drug, slated to come out this month. "While the drug has been in the market since 2000, apprehensions of it causing life–threatening diseases have always been expressed. The recent issue of JAMA was an eye opener. It's the reason why clinical trials of the drug have been put on hold for sometime," sources in the Health Ministry said.
Though the drug is sold in themarketwithaprecautionary warning, DCGI wants to be double sure. The Drug TechnicalAdvisoryBoard will now review and decide whether the clinical trials should be conducted or not.
"Innext10–15days,thingswill becomeclearer,"saidsources.
According to Dr Anoop Misra, Director and Head of Department of Diabetes and Metabolic Diseases, Fortis Hospitals, the drug should be banned completely. "In view ofrepeatedanddecisivedata, most clearly shown by this study, Rosiglitazone has no place in management of diabetes.InIndia,morethanany other country, this drug should be banned due to less than adequate knowledge of its adverse effects," he said.
Supported by pharmaceuticalcompanyGlaxoSmithKline, India is a part of an internationalgroup examining the risk factors involved in using Rosiglitazone. Clinical trials of the drug were last year approved by a number of developed countries, including the US, Canada, Denmark, Germany and Sweden and developing countries, including India, Chile, Columbia, Mexico and Pakistan.
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