The makers of the controversial anticoagulant Xarelto are trying to get approval for several new uses of the drug, despite repeated Xarelto bleeding problems cited in Xarelto lawsuits.

Xarelto

Xarelto is an anticoagulant, a class of drugs designed to prevent blood clots. While blood clotting is a normal part of the healing process in healthy humans, this process can misfire and cause blood clots to form within a person’s blood vessels.

When this happens, the blood clot (or “thrombus” in medical terms) can get stuck in the arteries and capillaries that feed important organs like the brain and heart. Drugs like Xarelto and Pradaxa reduce this risk by making it harder for the body to form blood clots in the first place. But all anticoagulants carry the risk of completely shutting off the body’s ability to clot, making a person more likely to suffer from uncontrollable bleeding from minor internal or external injuries.

Alleged Xarelto Side Effects

One alleged problem with newer anticoagulants like Xarelto is that they do not have approved reversal agents. Older anticoagulants like Coumadin (generic Warfarin) can be “shut down” with a reversal agent if a patient has bleeding problems.

In the case of Warfarin, a very high dose of vitamin K overwhelms the drug, blocking its ability to interfere with clotting. Newer anticoagulants such as Xarelto or Pradaxa lack such an agent, potentially making an uncontrollable bleeding event even more serious.

Both the U.S. Food and Drug Administration (FDA) and the makers of Xarelto have received hundreds of reports of uncontrolled bleeding in Xarelto patients.

Seeking New Approval

Despite concerns of alleged Xarelto side effects, the makers of the drug are currently trying to expand the use of the drug. Under federal law, a drug manufacturer must submit a drug for FDA approval for each use of a drug.

In the case of Xarelto, the drug is currently approved for use in one group of patients at high risk for stroke and other thrombus-related problems. Specifically, it is approved for patients with atrial fibrillation, a type of abnormal heart rhythm that can promote clot formation. However, the drug’s makers are currently seeking approval for use in other populations at risk for clots, specifically patients with acute coronary syndrome.

This is the fourth attempt to expand the use of Xarelto to these populations. The FDA has rejected the three previous attempts over Xarelto side effect concerns, specifically uncontrollable bleeding incidents.

Xarelto lawsuits have stated that the drug’s manufacturer has pushed the drug to make a profit. In fact, despite safety concerns and the assertion that older drugs are safer, Xarelto is on track to break the billion dollar profit mark this year, the “blockbuster” milestone for pharmaceuticals.