Side Effects Xarelto – A History Told Through FDA Warnings

Side Effects Xarelto

The side effects Xarelto story starts with initial approval in 2011, and the blood thinner has had an eventful journey, receiving several warnings from the U.S. Food and Drug Administration (FDA), as well as required labeling and advertising changes.

July 2011 – June 28, 2013

Xarelto is approved by the FDA for the treatment of deep vein thrombosis in patients undergoing knee replacement and hip replacement surgery, to reduce the risk of stroke in people with abnormal heart rhythm, and to treat and reduce the risk of deep vein thrombosis or pulmonary embolism.

August 2013

Xarelto makers Janssen Pharmaceuticals (Johnson & Johnson subsidiary) and Bayer AG were required to make changes to their advertisements after the FDA claimed that the companies downplayed the possible side effects associated with the drug.

Xarelto was also required by the FDA to carry a boxed warning advising consumers and the medical community that premature discontinuation of the drug would increase the risk of thrombotic events and spinal/epidural hematoma.

January 2014

The FDA issued five warnings and precautions regarding side effects Xarelto:

  • Physicians were advised to promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement in Xarelto patients.
  • A warning was issued advising that no specific antidote is currently available to counteract the anticoagulant effects of Xarelto.
  • Practitioners were warned to avoid combining Xarelto with P-gp and strong CYP3A4 inhibitors and inducers.
  • Because the safety and efficacy of Xarelto had not been studied in people with prosthetic heart valves, the medication was not recommended for those patients.
  • Xarelto was not recommended as an alternative to heparin in patients with pulmonary embolism.

February – March 2014

A side effects Xarelto boxed warning was issued by the FDA advising users of the dangerous side effects of Xarelto, including the lack of an antidote, and the risks associated with using the medication with epidural anesthesia and spinal puncture.

December 2014

More label changes: the adverse reaction thrombocytopenia was added to the Xarelto label, and the adverse reaction term “cytolytic hepatitis” was replaced with “hepatitis.”

Side effects Xarelto moves from regulatory actions to lawsuits.  Since Xarelto’s approval five years ago, Xarelto Lawsuits have been filed against Johnson & Johnson and Bayer AG alleging Xarelto side effects including gastrointestinal bleeding, rectal bleeding, internal bleeding, stroke, heart attack, pulmonary embolism, epidural hematoma, and brain hemorrhages. Some 2,800 cases have been consolidated into multidistrict litigation (MDL) in Eastern Louisiana and nearly 700 have been combined into a mass tort program in the state of Pennsylvania.