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Blood thinner drug Xarelto Bigger lawsuit because of side effects
The controversial drug Xarelto continues to make headlines. As the "Handelsblatt" and the "WDR" report, in the US, the number of complaints from users of the anticoagulant has risen to more 14,000. The charge: Xarelto is said to be responsible for serious damage to health and even deaths. The pharmaceutical company has now taken a stand and dismisses the allegations.
More than 14,000 complaints from users
The scandal surrounding the factor Xa inhibitor Xarelto is expanding: According to recent reports by the two media, thousands of lawsuits have been filed in the US against the pharmaceutical manufacturer Bayer. Xarelto contains rivaroxaban and is used to inhibit blood clotting in adults. It is used to treat deep vein thrombosis and pulmonary embolism, as well as to prevent stroke.
Thousands of users of the anticoagulant Xarelto have filed suit against Bayer. (Image: grthirteen / fotolia.com) The allegations against the company sound alarming, as the drug is associated with heavy bleeding and even deaths. According to the Bayer announcement, the number of complaints from users had increased to 13,800 by October this year. There are now more than 14,000 patient complaints, according to the reports of Handelsblatt and WDR.
Reference to assessment by regulatory authorities
However, the Group dismisses the allegations and points to the assessment of the new anticoagulants (NOAK) as well as Xarelto by reputable drug agencies: "Regulatory authorities worldwide granted approval based on clinical studies that demonstrate a positive benefit-risk profile for the NOAK," said the group in a recent statement. Accordingly, Bayer is investigating "the efficacy and safety profile of its anticoagulant continuously".
This corresponds to the introduction of the drug "the results from the clinical studies, in which already more than 85,000 patients have participated," explains the Group. Studies on use in everyday practice have confirmed "the positive benefit-risk profile in all indications," according to the information.
Billions in compensation for anti-baby pill
Nevertheless, the flood of lawsuits in the US could cost the company dearly. That happened at least in the course of the dispute over the contraceptive pill Yasmin or Yaz. By the end of January 2016, according to Bayer's own statements, Bayer had paid settlement payments to about 10,300 claimants without recognition of any liability. Around $ 2.04 billion was paid for diseases caused by venous blood clots such as deep vein thrombosis or pulmonary embolism. 7,200 claimants received around 21.5 million dollars for damage to the gallbladder.
Another lawsuit affected the pharmaceutical company Boehringer Ingelheim for years. He had received approximately 4,000 complaints for his stroke drug Pradaxa. In 2014 it was announced that the company had made a comprehensive settlement and would pay a total of 650 million US dollars (about 470 million euros) to the plaintiffs.
Defective devices kept secret?
In addition to the discussion of possible side effects of the drug, the research of the two media produced additional information that attracted attention. According to this, Bayer's US distributor Janssen should have kept secret from the authorities for years that various test devices were not fully functional during the registration study "ROCKET AF". From a critical point of view, this could mean that Xarelto's blood clotting scores and side effects profiles may have been miscalculated.
However, the group also rejects this accusation. Accordingly, after examining all information in its assessment report in February 2016, the European Regulatory Authority concluded that Bayer and Janssen "had no knowledge of the impact of the potential malfunction of the INR measuring device in the ROCKET AF study until 9 September 2015" so the message. Furthermore, both companies would have "ensured at all times that the regulatory authorities were provided with all the information they needed on past and ongoing clinical trials." (Nr)