Despite several lawsuits being filed against the makers of the anticoagulant Xarleto, the makers of the drug are planning on testing it for other uses. The push for additional FDA approvals come as several people have died as a result of taking the medication.
Xarelto took the majority of the marketshare from other blood thinning medication because of its several already-approved uses. The popularity of the drug is also a result of fact that it was seen as an easier to use blood thinner. Other drugs can require strict nutrition planning and regular blood testing.
The companies behind the drug – Bayer and Johnson and Johnson’s Janssen Pharmaceuticals – are seeking approval from the FDA for Xarelto’s use for stroke patients. A new trial consisting of 7000 patients will look at the differences in how effective Xarelto is in preventing potential future strokes compared to the current mainstay aspirin. Xarelto has already been denied approval for use in Acute Coronary Syndrome.
It has been stated that the drug enjoys approximately 33% of the previous leading blood thinner’s market share. This number may rise to 66% if additional approvals for use are granted. There is, however, always the possibility that the pending Xarelto litigation will impact the drug’s popularity, use and sales.
Both J&J and Bayer are under fire for their alleged negligence in properly warning patients and healthcare workers about the dangerous side effects associated with taking Xarelto. Several patients that used the drug have suffered from serious and uncontrollable internal bleeding – some of whom have died. There are hundreds of individual cases in the Xarelto mass tort, which were consolidated by a federal judge.