Diabetes drug increases risk of heart attack? Will the Avandia product be withdrawn from the drug market in Germany?
(08.09.2010) The drug "Avandia" from the pharmaceutical company "GlaxoSmithKline" continues to be criticized, since taking the diabetes medicine increases the risk of heart attack according to media reports. The British health authority has now ordered a stop to sales of the drug and doctors are also increasingly critical. They also criticize their own failure in the course of the approval process.
While the British pharmaceutical company "GlaxoSmithKline" (GSK) was already expecting growing income from the Avandia business, a current article in the renowned medical journal "British Medical Journal" and a message from the British Medicines Supervision (MHRA) have put a spanner in the works made. As recently as July of this year, the US Food and Drug Administration (FDA) was unable to make a recommendation to ban the drug and only complained about the significant side effects of the preparation. It has long been known that rosiglitazone therapies with Avandia can increase the risk of heart attack. Some doctors now complain in the "British Medical Journal" that in the course of the approval process for the European market in 1999 there were indications that the evidence for the benefits of the drug was insufficient. According to the members of the European approval authority Ema (" European Medicines Agency ") granted approval for the drug based on very poor information, also criticized Silvio Garattini, then a member of the Ema Committee and director of the Mario Negri Institute for Pharmacological Research in Bergamo. Garattini told the" British Medical Journal "that the study situation at the time was very poor and the committee originally wanted to refuse your admission.
Avandia came onto the market in 2000 and, until 2007, was one of the largest sources of revenue for the British company GSK with an estimated $ 3 billion a year (2009: sales of 1.2 billion). In 2007, the drug was heavily criticized for the first time, as a review study came to the conclusion that the preparation can cause heart problems. Avandia was actually developed to avoid heart problems in type II diabetes patients. "Ten years after the release of rosiglitazone, we still cannot estimate exactly what risks we are exposing our patients to," says John Yudkin of University College London. Studies at the time could have shown that rosiglitazone could reduce an important blood sugar level (glycohemoglobin HbA1c) by around one percent for diabetics, but the long-term consequences of such diabetes therapy were neglected, according to Yudkin. However, according to Yudkin, it is now clear that rosiglitazone therapy with Avandia significantly increases the risk of heart attack.
On Wednesday, based on the new findings, the Ema wants to take a closer look at the safety of the drug with various medical experts in order to present its final position until the next meeting of the Committee for Medicinal Products for Human Use in London on September 20-23. However, the UK drug regulator has already made its decision and has announced that Avandia "has no place in the UK market".
However, the German Federal Institute for Drugs and Medical Devices (BfArM) is somewhat more moderate in a statement and emphasized that it will continue to take part in the technical discussion on the benefit-risk ratio and that it will provide information on the state of the art on the BfArM website . However, the Federal Institute also refers to the "strict observance of the long-standing restrictions on the use of medicines containing rosiglitazone", which are listed on the package inserts in Germany. The head of the department for the supervision of approved medicines, Ulrich Hagemann, sees the safety concerns mentioned here fully confirmed. "After evaluating the previous studies, the BfArM sees the existing safety concerns increasingly well founded," the specialist told Spiegel Online and further emphasized that the BfArM therefore supports all steps in the EU that pursue an overall benefit-harm assessment of medicines containing rosiglitazone . However, from the experts' point of view, there is no need to panic, since "patients who are currently taking a drug containing rosiglitazone will be unsettled by the media reports that have just been published" and it would under no circumstances be expedient if they stopped taking the medication themselves. Patients "should never stop taking it uncontrolled and without advice from the doctor treating them," explained Hagemann. (Fp)
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