Diabetes drug Avandia to be banned amid heart attack fears
The Local · 25 Sep 2010, 10:40
Published: 25 Sep 2010 10:40 GMT+02:00
The Federal Institute for Medicines and Medicinal Products (BfArM) in Bonn said the next month should be used for patients to consult their doctors and change to a different medication.
German authorities say around 86,000 people in the country were taking the drug, used to treat Type 2 diabetes, last year.
Avandia has been controversial since a connection with an increased risk of heart attacks and strokes was established three years ago.
Yet the European Medicines Agency only ruled this week that it should be removed from the European Union market. It said on Thursday that the benefits of Avandia’s active substance rosiglitazone did not outweigh the risks.
The American medicines regulatory agency the FDA has said it will severely limit access to the drug but it will still be available in the US.
Avandia received European license in 2000 and became GSK’s second best selling drug, with global sales of $3 billion in 2006 until health concerns emerged in 2007 when figures plummeted.
Total sales of Avandia are expected to be between $157 million and $235 million in the second half of this year.