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FDA Warns Against Avandia

Avandia, a popular but controversial diabetes medication, is facing new government scrutiny, putting manufacturer GlaxoSmithKline at risk of potentially costly new lawsuits.

In February, the New York Times obtained a confidential Food and Drug Administration report that linked more than 300 deaths to Avandia within a three-month period. The report recommended pulling the drug from the market.

The new FDA data follows a U.S. Senate Finance Committee report released in February. The Senate report alleges that GSK knew of the health risks prior to 2007 but concealed them. Avandia could quite possibly be a dangerous and defective drug.

Avandia first hit the market in 1999 and sales peaked at more than $3 billion in 2006. In 2007, doctors and federal officials began raising health concerns over the drug. The FDA first issued a warning after the Cleveland Clinic released a study linking the drug to heart problems. Hundreds of thousands of diabetes patients still use the drug, though many doctors no longer prescribe it.

Meanwhile, GSK faces mounting legal pressure that could cost the British-based pharmaceutical company billions of dollars. This month, the FDA report prompted the largest county in northern California to sue the drug giant. The Santa Clara County suit accuses the company of suppressing evidence of health concerns and seeks restitution for all Avandia users in the state. The county is seeking triple damages because Avandia advertising was aimed at diabetics, who are considered disabled under state law.

A UBS financial analysis this month estimated that GSK could be liable for up to $6 billion if personal-injury lawsuits over Avandia are successful.