FDA Warning: 600,000 Avandia Users in the US Risk Heart Attacks, Stroke or Heart Failure

About 600,000 users of the controversial diabetes drug Avandia (rosiglitazone) are exposing themselves to possible heart attacks, strokes or heart failures. The US Food and Drug Administration (US FDA) has issued severe restrictions on the use of the drug manufactured by GlaxoSmithKline (GSK) because of the heart health risks.

Rosiglitazone is currently being taken by patients with Type 2 diabetes. Avandia is taken as a stand-alone medication or in combination with metformin (Avandamet) or with glimepiride (Avandaryl). It was the research of Cleveland cardiologist Dr. Steven Nissen which established a strong linkage between heart ailments and the use of the drug.

The US FDA’s restrictions on Avandia are as follows:

* GlaxoSmithKline (NYSE:GSK), the drug’s manufacturer, is restricted from promoting the drug. Individuals currently taking the drug will be advised to transfer to another similar medication
* Doctors cannot prescribe the diabetes drug to new patients without giving them detailed explanation on the risks involved.

GlaxoSmithKline (GSK) was also advised by the US FDA to to convene an independent group of scientists to re-check data on the drug’s clinical trials, USA Today reported earlier.

While Avandia is still available in the US, the European Union’s European Medicines Agency has altogether banned the sale of the GSK diabetes drug because of its record in clinical trials.

It is estimated that in the US more than 47,000 Avandia users suffered from a heart attack, stroke or heart failure during the period 1999 to 2009. Dr. Nissen said the FDA’s decision brought an end to “one of the worst drug safety tragedies in our lifetime.” He added that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”

Avandia was once the best selling diabetes drug in the market. In 2009 its sales went down to $1.2 billion from $3.2 billion in 2006 because of its risks to heart attacks and other heart ailments.

source: all247news