US FDA to remove certain restrictions on GSK’s diabetes drug

The US Food and Drug Administration is to remove certain restrictions on prescribing and use of GlaxoSmithKline’s diabetes drug, Avandia (rosiglitazone).

This decision was made to reflect new information regarding the cardiovascular risk of the medicine – clinical trials showed no elevated risk of heart attack or death patients being treated with Avandia when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007.

“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug. Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.”

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Once the changes are final, rosiglitazone’s indication for use will no longer be limited to certain patients. The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available.

 

 

 

Related news:

FDA Lifts Restrictions On GlaxoSmithKline’s Diabetes Drug Avandia, After New Study Showed No Elevated Risk Of Heart Attack (International Business Times)

Reference links:

FDA press release

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