In August 2006, a similar analysis by GlaxoSmithKline identified a 31 percent increase in cardiovascular risk. Although the company alerted the FDA to the safety concerns, it did not notify doctors or patients of the heart problems associated with the drug.
The FDA has come under fire in recent years for its failures in protecting the public from dangerous drugs. Lawmakers quickly reacted to the news, questioning whether Avandia further evidenced a breakdown at the FDA.
Representative John D. Dinglee, chairman of the House Energy and Commerce Committee, noted that the FDA has known about the problem for at least eight months. "What we don't know is why diabetics and their doctors haven't been notified of the substantial risk to the heart from a drug prescribed to protect the cardiovascular system.
An editorial that accompanied the May 2007 study in The New England Journal Medicine questioned why doctors would continue to prescribe Avandia given the availability of alternative treatments with more favorable risk profiles.
Avandia has been on the market since 1999 and is approved for the treatment of Type 2 diabetes. It is sold alone as Avandia and in combination with other drugs, including Avandamet and Avandryl. |