FDA Restrictions on Avandia Due to Heart Complications

In September of 2010, the Food and Drug Administration (FDA) announced that the sale of Avandia, a drug used for the treatment of type 2 diabetes, would hereafter be severely restricted in the United States. The FDA Avandia restriction was announced as similar agencies in Europe called for an all-out ban on the product.

Avandia is the brand name of the drug rosiglitazone, manufactured by GlaxoSmithKline. Over the years, it has proven effective at increasing type 2 diabetics’ sensitivity to insulin, allowing greater control over their blood sugar levels. Unfortunately, along with this greater control have come unfortunate side effects, the most serious of which is fluid retention.

Excess fluid in patients’ bodies may have caused heart failure, stroke, heart attacks, and death in over 47,000 Avandia users since 1999, according to the New York Times. The new FDA Avandia restrictions are aimed at lowering those numbers.

These Avandia FDA restrictions are a relatively extreme measure for the agency, which speaks to the seriousness of the Avandia issue. From now on, only patients who, along with their doctors, can insist that they have exhausted all other pharmaceutical options for their type 2 diabetes may be sold Avandia. Additionally, those who are currently taking the drug may continue to do so.

The FDA looked into the Avandia issue in 2007, as more and more Avandia lawsuits were being filed for adverse reactions to the dangerous drug. If you or a loved one has suffered injury from using Avandia, talk to an Avandia lawsuit attorney today.

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