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Kevin Duffan
Kevin Duffan
Attorney • (800) 752-0042

FDA Loosens Restrictions on Avandia

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In November 2011, the Federal Food and Drug Administration (FDA) tightened restrictions on the prescription drug Avandia. The diabetic medication was pulled from pharmacy shelves. Only certified physicians have been allowed to prescribe it. And for those patients who are prescribed the drug, they are required to be fully informed of all the risks linked to Avanida and can only fill their prescriptions by mail order through specific pharmacies.

The drug, used to treat Type 2 diabetes, had an extensive list of dangerous side effects, including liver toxicity, severe chest pains, congestive heart failure, stroke, vision changes, trouble breathing, head ache, back ache, anemia, respiratory infections, and brittle bones in women.

Last month, thirteen members of a 26-member FDA advisory committee voted to soften those restrictions. The restrictions were lifted not because the drug manufacturer has developed a safer version of the product with fewer side effects, but because the panel felt that doctors should have the freedom to prescribe it to their patients.

Before the dangers of the drug were discovered, Avandia earned its manufacturer, GlaxoSmithKline, more than $3 billion in sales. But sales plummeted after a Cleveland Clinic cardiologist publicized an analysis of all the research that demonstrated how Avandia increased the risk of heart attacks by more than 40 percent.

Glaxo’s Avandia’s patent expired in 2011. Another drug company has approval to sell a generic version of the drug, but has not introduced one to the market, presumably because of the restrictions and small amount of patients who currently take the drug. Glaxo puts that number at only 3,400.

Last year, in one of the largest healthcare fraud cases in the country, Glaxo agreed to pay $3 billion and plead guilty to marketing products for unapproved uses, including the antidepressant Paxil to underage patients. Also included in the settlement were charges of failing to provide the FDA with Avandia safety data.

Just this past week, the company agreed to pay $229 million to settle lawsuits with the eight states that declined to be included in last year’s settlement. Those states are Kentucky, Louisiana, Mississippi, Maryland, South Carolina, New Mexico, West Virginia and Utah. The news of the settlement comes as news of a major investigation by Chinese authorities over allegations that Glaxo has engaged in widespread bribery to help sell its medicines in China.