PPH Legal Blog

An FDA official has called for higher standards for approval following the recent problems with Avandia and other drugs used to treat diabetes.

The problems and scandal involving Avandia stem from a May report by the New England Journal of Medicine that said that diabetes patients taking Avandia had a 43% higher risk of heart attack than those in the study that were taking a placebo.

Now, the FDA official that had a part in reviewing GlaxoSmithKline’s original application for approval of Avandia is calling for stricter testing of new, experimental diabetes drugs. This staffer wants experimental drugs tested against existing drugs as opposed to the current process of testing against a placebo. The researched says that testing drugs in a vacuum doesn’t accomplish much; they need to be tested against other drugs.

In addition to being linked to heart attacks and heart failure, Avandia has also been linked to the chronic disease primary pulmonary hypertension.

If you or someone you know has taken Avandia and been diagnosed with PPH, there may be legal options available. Contact the PPH Lawyers of Williams Kherker at 1-866-950-9000 to discuss these options and to schedule an initial consultation.