Avandia Associated to Serious Heart Complications

Avandia Associated With Heart Complications

If you are a diabetic who has been prescribed Avandia to control your symptoms, take note – you may be at an increased risk for a heart attack or other heart ailments. Used to treat type 2, non-insulin dependent diabetes, and approved by the U.S. Food and Drug Administration (FDA) in 1999, Avandia has been linked to serious and potentially fatal injuries since hitting the market.

Avandia’s Controversial History

In September 2010, the FDA announced that it was restricting Avandia’s use to type 2 diabetics who cannot control their illness with other medications.

The European Medicines Agency, however, went a step further. It suspended approval for the marketing of Avandia in Europe, which could lead to the product being banned in that region along with two medications that combine Avandia’s active ingredient with other drugs: Avandaryl and Avandamet.

Avandia has been controversial since 2000, when consumer advocacy groups raised concern over the increased risk of both cardiovascular and liver complications, sometimes leading to death.

Avandia, generically known as rosiglitazone, carries an FDA required "Black Box" warning, which is required when a drug carries a risk of severe injury or death. The drug's manufacturer, GlaxoSmithKline (GSK), has issued an estimated 60 million prescriptions for the medication.

In 2006, GlaxoSmithKline changed the label to show an increased risk of heart problems for patients taking the drug in combination with insulin. A 2007 New England Journal of Medicine study reported that users of Avandia had a 43 percent increase in the risk of suffering a heart attack and a 64 percent increase in the risk of a heart-related death when compared to those taking another drug or a placebo.

Avandia conducted its own study of the medication, called the RECORD study, but it was blasted by an FDA advisory committee in July 2010, saying the company had ignored several cases of patients who suffered severe adverse effects.

Although the FDA has decided to keep the drug on the market in the U.S., it has ordered GSK to develop a program that makes sure Avandia’s marketing and use is tightly controlled, to pay for an independent review of the RECORD study and to cease any more work on a study that would have compared Avandia to a competitor’s drug, Actos.

If you are currently using Avandia, the FDA says you should talk to your doctor about its risks.

While cardiovascular-related issues are the most common reported with Avandia the use of the drug has also been linked to liver toxicity, increased risk of bone fractures, anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. In addition, users of Avandia could face an increased risk of osteoporosis and bone fractures.

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