The Food and Drug Administration (FDA) is responsible for assessing and approving new drugs that are being proposed to be marketed in the US as well as for deciding if the conditions for which an existing drug is already approved for can be expanded. This is a long, complicated process, requiring extensive preparations including properly designed clinical trials, and even then there is no guarantee that the FDA will give its blessing.
A good example for this is the oral anticoagulant drug Xarelto (rivaroxaban), which was first approved by the FDA in July 2011 for distribution the US, initially for the treatment of atrial fibrillation (irregular heartbeat). Currently, Janssen Pharmaceutical can market Xarelto as a treatment for six conditions, namely:
- Atrial fibrillation
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Recurrent DVT or PE post acute venous thromboembolism treatment
- Post-surgical prophylaxis following knee replacement procedures
- Post-surgical prophylaxis following hip replacement procedures
This puts Xarelto on the top of other anticoagulants in terms of broadness in its indication profile, and J&J together with the drug’s manufacturer Bayer are making significant efforts to broaden it even more by including acute coronary syndrome (ACS), peripheral artery disease, and embolic stroke. So far, though, the FDA has withheld approval for these latest applications.
Different anticoagulants target specific factors in the coagulation cascade, and may have varying degrees of risk of side effects. Xarelto is a direct factor Xa (10-a) inhibitor, a class of drugs known as “xabans.” According to an article on the website of lawyers Williams Kherkher, serious side effects can happen with Xarelto which include uncontrollable bleeding in the brain and liver failure. Even worse, there is no known way to reverse its effects, which can lead to potentially fatal complications.
If you have been prescribed with Xarelto and suffered serious injuries because of it, you need to get legal representation to help you get compensation. Make an initial consultation with a Xarelto lawyer as soon as possible to find out how to get started.