Deaths from stroke drug Pradaxa?

The Japanese Ministry of Health reports deaths from preventive stroke medication

21/08/2011

The Japanese Ministry of Health accuses the pharmaceutical manufacturer Boehringer Ingelheim of not having sufficiently informed about the risks of a drug for the preventive treatment of strokes. According to the ministry, 81 patients had severe bleeding. At least five people reportedly died of bleeding.

On its website, the Japanese Ministry of Health reports on some significant risks of a drug for oral preventive treatment of strokes of the drug „Prazaxa“ (in Germany Pradaxa) of the manufacturer Boehringer Ingelheim. According to the ministry, severe bleeding occurred in 81 cases in older patients. Five patients could not save the doctors and died. For this reason, the Ministry of Health is calling on the pharmaceutical company to provide further safety information. The funds were used to treat a total of 64,000 people in the period from mid-March to 11 August. The drug with the active ingredient „dabigatran etexilate“ has been approved for the prevention of stroke in patients with cardiac arrhythmias in the Japanese drug market since the beginning of this year.

In case of bleeding, no adequate antidote
Some time ago, scientists in the prestigious journal New England Journal of Medicine said in an editorial that there is no antidote to this type of thrombosis drug that can quickly reverse the effects of life-threatening bleeding. In the previous standard means for the preventive treatment of strokes with the drug warfarin, could be administered with high success rate vitamin K to stop bleeding. Other remedies also lack antidotes. These include, according to articles such drugs as Xarelto by Bayer and Johnson & Johnson, Eliquis by Pfizer and Bristol Myers Squibbsowie Lixiana by Daiichi Sankyo.

The development of preventive medicines before strokes is regarded as a steadily rising market in the pharmaceutical industry and thus also as a „big business“. For the past and older drug warfarin is considered difficult to dose in medical circles. In addition, patients need to work hard and comply with strict diets. Especially older people find it harder to comply with the tedious dietary requirements. In addition to other pharmaceutical companies, the manufacturer Boehriner Ingelheim hopes to replace the previous standard drug with its own funds. Some economists estimate the drug worth up to $ 20 billion.

Drug Pradaxa planned for Germany
In Germany, the drug will soon be available. In this country, it does not mean, however „Prazaxa“ rather „Pradaxa“. The preventive drug should be approved on the drug market from September 2011. Authorization for the EU market was approved by the European Medicines Agency in August this year. The patient target group are people with heart rhythm disorders atrial fibrillation. The drug should also be used here for the prevention of strokes. Germany is thus the first EU country to allow the use of preventive brain apoptic therapy for atrial fibrillation. On the world's largest drug market, the US, the Boehriner product has been available since November last year.

The group has meanwhile responded to the request of the Ministry of Health. So it is said in a statement of the press department Boehringer, the company is „The manufacturer is now urged to point out that the drug can lead to death in some patients due to heavy bleeding and the company should also point out that it is not an appropriate antidote to Abolition of the anticoagulant effect exists.

Doctors should therefore make an accurate diagnosis before a prescription so that the risk of an undesirable consequence can be accurately determined. Among other things, there is an increased risk in patients with renal impairment and concomitant use of other anticoagulants. If taken concomitantly, anticoagulant effects may add up, increasing the risk of bleeding. (Sb)

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Picture: Tommy S.