Avandia: Does it Have Risks for Your Heart?

The diabetes drug Avandia was thought to be potentially damaging to the heart and was restricted severely in 2010. The FDA is now going to have a meeting in June to discuss the re-evaluation of the safety of this drug by GlaxoSmithKline. Outside experts will be engaged to give their opinion on the safety of this drug.

The drug company themselves undertook a study over five years in which diabetes patients on Avandia were monitored. They found that the heart health of their patients was not that much different from patients on other diabetes drugs. However, the results of this study were questioned by the FDA as some of their scientists said that the study under-reported heart problems.

This resulted in a restriction being placed on the diabetes patients that could take Avandia. It is usually considered as a last resort drug. Patients can only take Avandia now after signing a waiver stating that they know the risks of taking it, and that they have tried other drugs first. These restrictions could possibly loosen if the re-evaluation finds that Avandia is not as harmful to the heart as was previously thought.

Avandia was first approved in 1999 and was the most popular diabetes pill globally by 2006. The drug reached sales of $3.4 billion at its peak. However, sales began to decline rapidly after scientists began to question the safety of Avandia. It was banned in Europe and subsequently severely restricted in the U.S.A.

GlaxoSmithKline was accused of not reporting safety problems with Avandia to officials over a seven-year period. Overall, there was a $3 million settlement with the Department of Justice after GlaxoSmithKline plead guilty to failing to report the problems. This settlement involved ten different drugs from GlaxoSmithKline and various civil and criminal violations.

The FDA’s re-evaluation of this drug could result in the restrictions on Avandia being lifted somewhat, if it is found that Avandia is not actually as damaging to the heart as was previously thought. This could mean that many more diabetes patients could be able to take Avandia to help their condition without having to sign a waiver with their doctor.

Dangerous drugs can bring harm to you or your loved one. If this is the casefor you or a loved one, call Goldberg & Osborne at 1-800-THE-EAGLE (1-800-843-3245) for a free evaluation of your claim. You can also contact us through our simple case form to see if you have a case. Click here now

Related Resources: