FDA panel to revisit restrictions on GSK’s Avandia
An US Food and Drug Administration panel of medical advisors is expected to begin a two-day meeting today to revisit the six-year-old debate regarding the safety of GSK's diabetes drug, Avandia.
In 2010, the FDA heavily restricted the use of Avandia in the United States following controversy over a possible increased risk in heart attacks and strokes seen in a large clinical trial known as RECORD. The drug was withdrawn from the European market the same year and its US patent ended in 2011. No generic versions of the diabetes drug were created and today only approximately 3000 Americans take Avandia, according to Reuters UK. Since then, independent researchers have concluded that the drug doesn't increase the risk of cardiovascular death, but critics continue to question the drug's safety.
However, despite the possibility that the FDA panel could recommend to lift the sales restrictions, GSK has said it has no plans to promote Avandia again. But a positive recommendation from the FDA panel could protect the company for liability.
Related news:
FDA panel revisits Avandia; likely too late for diabetes drug (Reuters UK)
FDA to consider lifting safety warnings on Avandia, but is it too little, too late? (Market place)
