Archive for the ‘avandia’ Category

Avandia Back in the News

Tuesday, June 29th, 2010

CBS Evening News (6/28, story 10, 0:30, Smith) reported FDA experts meet in two weeks to decide whether or not to pull Avandia (GlaxoSmithKline) off the market, while Brian Williams of NBC News also reported yesterday (June 28,3010) , however, that the drug’s maker, GlaxoSmithKline, “said today the drug is effective and safe.” The drug (Rosiglitazone) is still used for millions of patients with type II diabetes, although several other drugs are available for treatment of the condition.The drug was linked to 304 deaths in the third quarter of last year.

Yet, three years ago in May 2007, and followed by many other reports, Avandia was linked to a 43 percent greater risk of heart attack and death in a study published by the New England Journal. See this link.The FDA is still in a bind despite a recommendation last February that the drug be taken off the market. (Supposedly) when a drug maker refuses to pull a potentially fatal medication off the market, the FDA, believe it or not, does not necessarily have the authority to force a recall. “In the interests of free commerce” (see link above), though The FDA has authority to force a black box warning be placed on the drug, the Agency does not have explicit power to force a company to remove the drug from the market. According to the above link “As long as the risks and benefits of a drug are fully disclosed to a patient and the patient voluntarily consents to its use, the FDA has no power to interfere in that patient’s treatment.”Stay tuned.