FDA reviews Pradaxa anticoagulant

FDA inspects Pradaxa anticoagulant

08/12/2011

The US Food and Drug Administration (FDA) is testing the anticoagulant Pradaxa of the German drug manufacturer Boehringer Ingelheim. The drug is suspected of causing severe internal bleeding in kidney disease. While reports of drug-related deaths are increasingly unsettling patients, Pradaxa's investors are delighted. Bayer stock is currently one of the most sought after commercial paper on the German stock market.

The US Food and Drug Administration (FDA) is investigating the Pradaxa drug approved in 2010 for potential side effects. According to the FDA, there are reports that the drug could cause severe internal bleeding in patients. Currently, according to the FDA, Pradaxa, when used properly, offers good benefits for patients with cardiac arrhythmias „atrial fibrillation“. For this reason, the medicine should not be discontinued without consultation of the attending physician.

Since the market launch in 2008, according to press reports, at least 260 people worldwide have died after taking the drug. Previously, only 50 deaths were confirmed by pharmaceuticals. Meanwhile, the Boehringer Ingelheim Group has confirmed the probable death toll. So it was said from the side of the group, although there are these suspected cases, the drug as such is effective and does not jeopardize the health of patients when used properly. Most affected were patients whose kidney functions were severely impaired.

Laughing third is the pharmaceutical giant „Bavarian“. Its drug Xarelto also belongs to the new class of anticoagulants. Bayer, too, expects a billion-dollar business in the future, because people in the western industrialized nations are getting older and therefore suffer more frequently from cardiac arrhythmias. The company has received approval for the new stroke prevention drug for patients with atrial fibrillation in early November. Due to the negative headlines of the competition and the introduction of its own drug, the share recorded a price premium of 1.7 percent to 47.98 euros, making it one of the most coveted stocks in the German market.

The FDA has announced that it will work closely with the pharmaceutical company Boehringer to analyze the reported cases. Although the FDA notes that there is currently still a safe drug, the test is a signal for the markets.

But is the competitor Bayer looking too early? Today, the FDA also wants Bayer-produced hormonal contraceptive pills „Yasmin“ and „Yaz“ examine more closely. Some recent studies indicated an increased risk of thrombosis formation in both pills. In negative reports Bayer could also come in Schlingern, because the contraceptives are the second-strongest product group from Bayer. (Sb)

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Picture: Gerd Altmann