Diabetes Drug to Carry 'black Box' Warning of Congestive Heart Failure Risk

by VR Sreeraman on  June 18, 2007 at 4:39 PM Drug News   - G J E 4
Diabetes Drug to Carry 'black Box' Warning of Congestive Heart Failure Risk
The US Food and Drug Administration has announced that the wrappers of the diabetes drug Avandia will soon start carrying a prominent "black box" warning about the risk of congestive heart failure.

Some of the experts, who have been reviewing the drug for the FDA, feel that the delay in implementation is an example of industry versus science, where the latter has been a loser.

GlaxoSmithKline's Avandia has been in use since 1999. The concerns over its possible heart-related side effects have been raised by diabetes specialists.

FDA reviewer Rosemary Johann-Liang says that she had proposed for a stronger warning, but the agency ignored her proposal. According to the New Scientist, the FDA is now investigating her claims.

Francesca Grifo, Director of the Scientific Integrity Program at the Union of Concerned Scientists in Washington DC, says that science is often sacrificed and reviewers' opinion stifled in favour of drug makers, who push for speedy approvals.

The US House of Representatives is mooting the legislation to boost the evaluation of drugs' safety after they go on sale.

Source: ANI

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