Press Release, April 5, 2013
Coalition against BAYER Dangers (Germany)
Bayer Annual Stockholders' Meeting on April 26
Anticoagulant Xarelto under fire
Concerns regarding the safety of the anticoagulant Xarelto have not been dispelled. Trials carried out with the drug have resulted in a number of fatalities. Dubious practices are also being used to market the product. There are justified fears that a high-risk, over-expensive product with no additional therapeutic benefit is being forced onto the market.
There are considerable doubts about the safety of the new anticoagulant Xarelto, which BAYER is doing all it can to push onto the market. Data from the German Federal Institute for Drugs and Medical Devices (BfArM), which the Coalition against BAYER Dangers obtained on request, reveal that last year in Germany alone there were 58 deaths following the use of this drug and 750 cases of serious side effects.
In the US, registration of this product to treat blood clots in the coronary arteries has been delayed. In view of the high risk of bleeding, the FDA recently asked BAYER to submit further data on the risks of Xarelto. In February 2012 the FDA had already criticized BAYER because three deaths had not been documented in the dossiers submitted.
Previously BAYER encountered problems in the US authorization processes for the indications “prevention of thrombosis in knee and hip surgery and “prevention of stroke and embolism in patients with atrial fibrillation. The FDA asserted, among other things, that BAYER did not correctly set the dosages for study participants in the control group treated with Warfarin (related to Marcumar).
Experts advise against the use of Xarelto and advocate continued use of the established medications Marcumar or Warfarin. For example, the Drug Commission of the German Medical Association stated: “Overall, in the Commissions view, where cardioembolism in patients with atrial fibrillation can be effectively prevented through treatment with vitamin K antagonists such as Phenprocoumon, there are no advantages in treatment with dabigatran or rivaroxaban (Xarelto). Their use should be confined to patients for whom vitamin K antagonists are not a treatment option. Alongside price considerations – it is 15 times cheaper than Xarelto – the main argument in favour of Marcumar/Warfarin is that an antidote exists that can halt severe bleeding. This is not the case with Xarelto.
The approval process for Xarelto was difficult from the very beginning due to the many side effects and unclarified long-term effects. In India, at least four people taking part in the Xarelto trials have died. In each case, BAYER paid the surviving dependents a mere USD 5,250 as compensation. In the United States, therefore, Xarelto will be marketed with a warning that patients should not stop taking the drug without consulting a physician, as there is otherwise an increased risk of strokes occurring.
Axel Koehler-Schnura from the Coalition against BAYER Dangers stated: “It is wrong for BAYER to press ahead with the marketing of a medication simply for profit reasons in the face of considerable doubts about its safety. The company should have learned from the LIPOBAY, TRASYLOL and YASMIN scandals. On principle, preparations that do not offer any benefit compared with older products should not receive marketing authorization.
The Coalition against Bayer-Dangers has been monitoring BAYER for more than 30 years. The Coalition introduced countermotions to the upcoming Bayer shareholder meeting that the company has published on their website: http://www.bayer.com/en/stockholder-counter-motions.aspx.