Trials of 'unsafe' drug for diabetes stopped
DELHI: 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.
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
development is significant in the wake of the fact that a total of around
2,000 diabetics were to be enrolled from India.
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.
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.
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."
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.