GlaxoSmithKline Identifies Significant Increase in Avandia Cardiovascular Risk
What’s the problem?
In August 2006, an analysis by GlaxoSmithKline identified a 31 percent increase in cardiovascular risk. Although the company apparently 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 close scrutiny 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.
Chairman of the House Energy and Commerce Committee John D. Dinglee noted that the FDA knew about the problems at least eight months prior. “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 of Medicine questioned why doctors would continue to prescribe Avandia, given the ability of alternative treatments with more favorable risk profiles.