Xarelto and the FDA

By Andrew Sullo


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Xarelto FDA Approval

Xarelto (Rivaroxaban), manufactured by Janssen Pharmaceuticals and Bayer, was first approved by the FDA in July, 2011 as a treatment in the prevention of deep vein thrombosis for those undergoing hip or knee replacement surgery. Just four months later, Xarelto FDA approval was received for the prevention of stroke in those with abnormal heart rhythm, and in November, 2012, Xarelto FDA approval was received for treatment and reducing recurrence of blood clots. The first bid for Xarelto FDA approval was rejected due to missing data.

Blood clots occur when blood thickens and clumps together; deep vein thrombosis is a blood clot which forms in a vein, deep in the body, most often in the lower leg or thigh. When such a blood clot breaks and travels to a lung artery, a potentially deadly condition known as PE occurs. In February, 2014, the FDA rejected the use of Xarelto as an oral anticoagulant to treat those with acute coronary syndrome. This rejection was the third for Bayer and Janssen regarding Xarelto FDA approval. In denying this latest request, the Cardiovascular and Renal Drugs Advisory Committee voted 10-1 against recommending approval for Xarelto to treat acute coronary syndrome. Xarelto FDA approval was also denied for use in reduction of stent thrombosis.



Why Was Xarelto FDA Approval Denied for Treatment of ACS?

Acute coronary syndrome (ACS) is an umbrella term which covers conditions brought on by a sudden reduced blood flow to the heart and can include chest pain and actual heart attack. The current primary Xarelto FDA approval is to prevent blood clots and strokes in those with atrial fibrillation—a condition which occurs most often in the elderly. In this latest FDA rejection, the safety and effectiveness of Xarelto for acute coronary syndrome and stent thrombosis was evaluated in three clinical studies, with a total of 9,478 patients. The study was intended to measure how many patients experienced recurrent symptoms of DVT, PE or death, following treatment with Xarelto, a combination of Warfarin and a vitamin K antagonist, or a placebo. A slightly higher number of those treated with Xarelto as compared to Warfarin and vitamin K experienced a recurrence of DVT and PE.

XSerious Side Effects Associated With Xarelto

The primary serious side effect connected with Xarelto is uncontrolled bleeding. In a 2012 Coalition Against Bayer Dangers held in Germany, concerns regarding the safety of 2012 were not dispelled, and during a number of clinical trials, the drug resulted in fatalities. In fact, over seventy deaths were associated with Xarelto in 2013, and over fifty in 2012. At the Coalition, many voiced concerns that dubious practices were being used to market Xarelto. Christiane Schnura from the Coalition stated “The numerous reports of vascular occlusion, bleeding, cardiovascular problems and liver damage make it inadvisable to use Xarelto on a wide scale for the prevention of stroke.” Regarding Xarelto and the FDA, the Coalition claims that advisers from that agency recently came to the conclusion that “Xarelto offers no additional therapeutic benefit compared with Warfarin…”

Xarelto FDA Warnings

Xarelto FDA warnings resulted in the requirement that the literature with Xarelto state premature discontinuation of the drug can increase the risk of thrombotic events and that if Xarelto is discontinued for any reason other than pathological bleeding, coverage with another anticoagulant should be considered. The second warning relates to epidural or spinal hematomas which can occur in those treated with Xarelto when they undergo spinal procedures or neuraxial anesthesia. These hematomas can result in long-term or permanent paralysis. A higher risk of spinal paralysis can occur in those with a history of epidural or spinal punctures, spinal surgeries or use of other anticoagulant drugs, platelet inhibitors and NSAIDs.

Other Xarelto FDA Issues

In March, 2014, a Xarelto FDA Safety Communications was issued to the public. The Xarelto Safety Communication warned that the optimal timing between the administration of Xarelto and spinal procedures was not known. The Safety Communication also stated that:

  • To reduce the potential risk of bleeding associated with Xarelto used at the same time an epidural or spinal anesthesia or spinal puncture occurs, the anticoagulant effect of Xarelto should be considered low.
  • Patients receiving an epidural or spinal anesthesia or lumbar puncture should be monitored frequently to detect any signs or symptoms of neurological impairment when taking Xarelto.
  • If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression.

The Xarelto FDA Safety Communication also warns that the safety and efficacy of Xarelto has not been studied in patients with prosthetic heart valves. Initiation of Xarelto is also not recommended as an alternative to heparin in patients with pulmonary embolism who present with hemodynamic instability. The FDA also issued Safety Communications for a similar drug, Pradaxa, following notification by patients and physicians of serious bleeding events. In Safety Communications regarding Pradaxa, patients are warned to call their healthcare provider if they experience any of the following:

  • Frequent or unusual nose bleeds
  • Bleeding from the gums
  • Unusually heavy menstrual bleeding
  • Pink or brown urine
  • Red or black stools
  • Bruises than continue to enlarge with no known cause
  • Coughing up blood
  • Vomiting blood

It is expected that if more people develop issues associated with Xarelto, more Xarelto issues will arise, and that the number of Xarelto lawsuits may also increase. If you have suffered adverse health problems after taking Xarelto, you are encouraged to speak to a knowledgeable Xarelto attorney at the earliest possible time.

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