23 July 2010
By Rupali Mukherjee
New Delhi, India
The US Food and Drug Administration (FDA) has directed pharma biggie GlaxoSmithKline to stop enrolling new subjects worldwide for conducting safety studies of controversial diabetes pill, Rosiglitazone (Avandia) till regulators decide whether the drug will be banned.
In India, at least 20 cities including Mumbai, Bangalore, Chennai and Hyderabad had enrolled over 150–200 subjects earlier this year for conducting these clinical trials, which are part of the global post–marketing studies to asses its safety risks.
This development is significant in the wake of the fact that a total of around 2,000 diabetics were to be enrolled from India. A debate has been raging on the blockbuster drug, Avandia since studies reported serious side–effects like heart attacks and strokes associated with its use, in 2007. It is widely–prescribed by doctors here in India, with 9–10 companies marketing it.
It is understood that country’s drug controller general recently halted the trials, for which subjects were being enrolled since February, across various hospitals and clinics all over.
Dr Anoop Misra, director and head diabetes, Fortis Hospitals in New Delhi said: “This step taken by FDA of stopping this unethical trial is welcome, though belated. I hope further step of banning this drug is taken soon. I am also happy to note that DCGI (India) stopped this trial in India before FDA decision, and such efficient steps and regulations are required in India.”
Doctors whom TOI spoke to said they welcomed the move of halting trials on new patients. With this development, the drugs use should be restricted, and only prescribed if absolutely essential.
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