Diabetes drug increases heart attack risk?

Diabetes drug increases heart attack risk? Will the Avandia product be taken from the drug market in Germany, too??

(08.09.2010) Drug „Avandia“ of the pharmaceutical company "GlaxoSmithKline" is still in the criticism, as with the use of the diabetes drug, the risk of heart attack significantly increases according to media reports. The British health authority has now ordered a stop of sales of the drug and doctors are also increasingly critical. They also complain about their own failure in the context of the admission procedure.

While the British pharmaceutical company "GlaxoSmithKline" (GSK) was already expecting growing revenue from the Avandia business, a current article in the renowned medical journal "British Medical Journal" and a message from the British Medicines Regulatory Commission (MHRA) are now beating the group made. In July of this year, the US Food and Drug Administration (FDA) had not been able to decide on a ban recommendation and only criticized the significant side effects of the drug. It has long been known that rosiglitazone therapies with Avandia can increase the risk of heart attack. So some doctors complain now in the „According to the British Medical Journal, "there were indications that the evidence for the benefit of the drug was insufficient in 1999, as European Medicines Agency members said Silvio Garattini, then a member of the Ema Committee and director of the Mario Negri Institute for Pharmacological Research in Bergamo, complains that the information available to him is very poor, and Garattini admitted to the "British Medical Journal" that the research was back then was very poor and the committee originally wanted to reject your.

Avandia was launched in 2000 and was valued at $ 3 billion a year by 2007, making it one of the biggest sellers of UK-based GSK ($ 1.2 billion in 2009). In 2007, the drug was then for the first time massively in the criticism, as a review study came to the conclusion that the drug can cause heart problems. Avandia was actually developed to prevent heart problems in Type II diabetes patients. "Ten years after the release of rosiglitazone, we still can not predict exactly what risks we expose our patients to," says John Yudkin of Universitiy College in London. For example, at the time, research had shown that rosiglitazone can reduce the level of diabetes (glycohemoglobin HbA1c), which is important for diabetics, by about one percent, but the long-term effects of such diabetes therapy have been neglected, according to Yudkin. However, according to Yudkin, it is clear that rosiglitazone therapy with Avandia significantly increases the risk of heart attack.

On Wednesday, Ema wants to re-examine the safety of the drug on the basis of the new findings with various medical experts in order to present its final position until the next meeting of the Committee for Medicinal Products for Human Use on 20 to 23 September in London. However, the UK drug regulatory authority has already made its decision and announced that Avandia "no longer has room in the UK market".

However, the German Federal Institute for Drugs and Medical Devices (BfArM) stated in a statement somewhat more moderately and emphasized that they would continue to participate in the technical discussion on the benefit-risk ratio and inform on the homepage of the BfArM about the state of science , However, the Federal Institute also refers to the "strict observance of the long-standing restrictions on the use of rosiglitazone-containing medicinal products", which are listed in the package leaflets in Germany. The security concerns mentioned here are fully confirmed by Ulrich Hagemann, Head of the Department for Monitoring Authorized Medicines. "The BfArM believes that the existing safety concerns are increasingly justified," the expert explained to Spiegel Online, adding that the BfArM therefore supports all steps in the EU that are pursuing a holistic benefit-harm assessment of rosiglitazone-containing drugs , However, from the perspective of the expert, alarmism is not appropriate since „Patients who are currently taking rosiglitazone-containing medicines are unsettled by the published media reports“ and in no case would it be expedient for them to discontinue the drug treatment on their own initiative. patients „should not stop the intake uncontrolled and without advice from the attending physician, "said Hagemann. (fp)

Also read:
Payments for diabetes drug Avandia
Diabetes is not a fate
Diabetes agent Avandia under infarction suspicion

Picture: Rainer Sturm