Pharmaceutical company Bayer rejects allegations
The controversial drug Xarelto continues to make headlines. As reported by the "Handelsblatt" and the "WDR", the number of lawsuits by users of the anticoagulant in the United States has risen to more than 14,000. The accusation: Xarelto is said to be responsible for serious damage to health and even death. The pharmaceutical company has now taken a stand and denies the allegations.
More than 14,000 lawsuits from users
The scandal surrounding the Xarelto factor Xa inhibitor is widening: According to current reports by the two media, thousands of lawsuits have been filed against the pharmaceutical manufacturer Bayer in the United States. Xarelto contains the active substance rivaroxaban and is used in adults to inhibit blood clotting. It is used to treat deep vein thrombosis and pulmonary embolism and to protect against a stroke.
The allegations against the company sound worrying because the drug is associated with heavy bleeding and even death. According to the Bayer announcement, the number of lawsuits filed by users rose to 13,800 by October this year. In the meantime, there would be more than 14,000 patient complaints, according to reports from Handelsblatt and WDR.
Reference to assessment by regulatory authorities
However, the group rejects the allegations and refers to the assessment of the new anticoagulants (NOAK) such as Xarelto by renowned pharmaceutical authorities: "Regulatory authorities worldwide granted approval on the basis of clinical studies that prove a positive benefit-risk profile for NOAK" the group in a current statement. Accordingly, Bayer is "continuously examining the efficacy and safety profile of its anticoagulant".
Since the introduction of the product, this has corresponded to "the results from the clinical studies in which more than 85,000 patients have already participated," explains the company. Studies on use in everyday practice have confirmed "the positive benefit-risk profile in all indications", according to the information.
Billions of compensations for birth control pills
Nevertheless, the flood of lawsuits in the United States could cost the company dearly. This happened at least in the course of the legal dispute over the birth control pill Yasmin or Yaz. Bayer stated that it had paid comparative payments to around 10,300 claimants in the United States until the end of January 2016, without accepting 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 approximately $ 21.5 million in total due to gallbladder damage.
Another legal dispute concerned the pharmaceutical company Boehringer Ingelheim for years. He had received around 4,000 lawsuits 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 to the plaintiffs.
Defective devices concealed?
In addition to the discussion of possible side effects of the drug, research by the two media produced additional information that attracted attention. According to this, Bayer's US sales partner Janssen has kept secret from the authorities for years that various test devices were not fully functional during the "ROCKET AF" approval study. From a critical point of view, this could mean that Xarelto's blood coagulation values and side effect profiles may have been incorrectly recorded.
However, the group also rejects this accusation. Accordingly, the European approval authority, after checking all the information in its evaluation report in February 2016, came to the conclusion that Bayer and Janssen "had no knowledge of the influence of the potential malfunction of the INR measuring device in the ROCKET AF study until September 9, 2015" , the message. Furthermore, both companies "always ensured that the regulatory authorities receive all the information they need regarding past and ongoing clinical studies." (No)