FDA to Revisit Restrictions on Diabetes Drug Avandia
NOVEMBER 25, 2013 UPDATE—In June, a Food and Drug Administration (FDA) advisory panel voted to recommend looser restrictions on the diabetes drug Avandia, although a final decision concerning the extent of those restrictions had not been made, until now. The FDA recently announced that after considering new information regarding the cardiovascular risk linked to Avandia, the agency will remove some of the controversial drug's prescribing restrictions.
One loosened restriction, introduced in 2010, limited Avandia use to patients with type 2 diabetes who could not control their illness using other medications, thus significantly reducing the number of patients taking the drug. That decision was largely based on a study that showed a 43% increase in heart attacks in patients taking Avandia. However, new results from a study conducted by GlaxoSmithKline, the drug's manufacturer, show no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs.
The FDA claims that the loosened restrictions reflect the most current scientific knowledge about the risks and benefits of the drug, yet one FDA scientist asserts that GlaxoSmithKline's findings ignored several cases of patients who suffered adverse side effects. Overall, the majority of FDA panelists felt that some of Avandia's harsh prescribing restrictions were more severe than necessary, but should not be removed entirely.
JUNE 11, 2013 UPDATE—A panel of 26 Food and Drug Administration (FDA) officials voted to recommend looser restrictions on the diabetes drug Avandia. The voting came after the drug's manufacturer, GlaxoSmithKline, requested a reconsultation of the drug, which they claim is safe if taken by proper patients according to labeling. A research institution independent of both the FDA and GlaxoSmithKline found results that supported GlaxoSmithKline's initial claim that the drug is safe.
The FDA commissioner will make the final decision to modify or eliminate restrictions on Avandia, based on the advisory panel's voted recommendations. If the commissioner allows looser restrictions, there could be an increase from the approximate 3,000 patients that currently take Avandia. Before the drug's heavy restrictions, about 120,000 patients were taking it.
JUNE 4, 2013 ORIGINAL STORY—Just when medical officials and consumer groups thought the controversies surrounding the dangerous drug Avandia were over, the Food and Drug Administration (FDA) decided to reopen the case against the drug manufactured by GlaxoSmithKline.
The FDA approved Avandia in 1999 to treat type II diabetes, but it took about seven years to discover that the drug causes critical heart-related side effects. Clinical tests found that patients taking Avandia have a 43 percent higher rate of heart attack and 64 percent higher risk of death than those not taking the drug. Over a 10-year period, the drug was linked to at least 47,000 cases of heart attack, stroke, and heart failure. But it wasn't until 2010 that the FDA heavily restricted use of the drug, limiting it to patients with diabetes so severe that Avandia might be worth the risk of heart failure.
Now, the FDA is reevaluating GlaxoSmithKline's clinical trial and plans to discuss Avandia's restrictions. Because Avandia's earliest studies proving its risks were potentially less reliable than the GlaxoSmithKline trial being reevaluated, revisiting the early studies might be valuable. Avandia was once a top-selling diabetes drug, and if the FDA reconsiders its restrictions, it could mean a more effective treatment for diabetes patients, who often must try several prescriptions before having reliable results.
Many medical officials say that fewer restrictions are unlikely, given the overwhelming evidence of heart-related risk.
Did You Suffer from Heart Problems After Taking Avandia?
If you, or someone you love, suffered from a heart attack, stroke, or other heart-related injury after taking Avandia, you may have a case. At Edgar Snyder & Associates, we have experience going up against prescription drug manufacturers, and we'll fight to get you the compensation you deserve for your medical bills, time off work, and pain and suffering.
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