FDA Wants Avandia Pulled from Market

The Wall St. Journal is reporting that the FDA has recommended to GlaxoSmithKline that it pull its diabetes drug Avandia from the market because of its association with heart attacks.
The studies are part of a report released by the Senate Finance Committee. Initial reports of an FDA market withdrawal were published in Saturday’s edition of the NY Times. Avandia’s difficulties began in 2007 when Cleveland Clinic cardiologist Steve Nissen published a study in the New England Journal of Medicine that found Avandia users were subject to a 43% higher risk of heart attacks than those who used other diabetes drugs. Glaxo added a “black box” warning to Avandia in November 2007.
According to the Wall St. Journal, the conclusions drawn by the Senate Finance Committee were critical of Avandia’s manufacturer.
“The Senate Finance Committee report concludes that Glaxo was aware of the possible cardiac risk years prior to Dr. Nissen’s study. The report says Glaxo had a duty to warn patients and the FDA about its concerns in a timely manner. “Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk,” the report says.