FDA Xarelto Internal Bleeding Warning
On June 6, 2013, Johnson & Johnson received an FDA warning letter related to the prescription drug Xarelto. The FDA warning cited a J&J subsidiary, Janssen Pharmaceuticals, Inc., for misbranding of Xarelto in violation of the Federal Food, Drug, and Cosmetic Act. Specifically, the company was cited for engaging in false or misleading advertising for Xarelto, by minimizing the risks associated with the drug and making false claims.
The Xarelto FDA letter notes that the company’s advertising material “misleadingly minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims”. In other words, the company highlights statements about the effectiveness of Xarelto – some statements of which are debatable – and downplays the known serious risks of extreme bleeding.
The FDA Xarelto letter goes on to state that the company may not claim that Xarelto requires no dosage adjustments. Persons who suffer from renal problems have been found to require careful Xarelto dosage adjustment to prevent further kidney damage. However, the risk of Xarelto bleeding is by far the most common and severe side effect of the drug. Understating this risk or failing to warn consumer adequately constitutes misbranding, and prevents patients from making an informed choice about the drug’s risks.
FDA Records Cases of Xarelto Thromboembolism
Similar to Pradaxa, another new oral anticoagulant, an increasing number of adverse events have been reported through FAERS, the FDA’s Adverse Event Reporting System. But unlike other oral anti-coagulants, which are having the most profound negative impact on high risk elderly patients with preexisting heart conditions, Xarelto is most often causing severe bleeding in younger, healthier patients (median age 66) who are in recovery from hip or knee replacement surgery. Pulmonary, venous, and other forms of thromboembolism are among the serious adverse events reported in patients taking Xarelto. Each of these conditions is related to blood clots becoming lodged in a part of the body and cutting off vital blood flow to the organs.
FDA Rejects Wider Uses of Xarelto
In February of 2014, the FDA rejected a proposal by Bayer AG and Janssen Pharmaceutica to expand the uses of Xarelto. Currently approved to treat patients suffering from atrial fibrillation and recovering from major joint replacement surgery, the drug makers proposed Xarelto uses be expanded to include patients with heart problems including a history of heart attacks or chest pains, and to prevent the clogging of heart stents.
FDA panelists rejected this proposal for the second time in 2014; the companies had previously applied to expand Xarelto’s indications to include heart problems known as acute coronary syndrome (ACS) in 2011. Each time, the FDA panel determined that there was not enough data to show the benefits of the drug were strong enough to outweigh the risks of Xarelto bleeding and hemorrhagic stroke. Thrombin inhibiting anticoagulants are approved for treatment of acute coronary syndrome, for patients who have already sustained a heart attack or stroke, or who suffer from chest pain.
Xarelto was designed and marketed as an alternative to warfarin, another blood thinner. After a fast-track regulatory review, Xarelto was embraced by many doctors and prescribed to a large number of patients. Today, many doctors are skeptical about the drug’s safety and benefits, based on the large number of Xarelto internal bleeding incidents recorded by the FDA. It is evident the debatable benefits of Xarelto may not warrant its serious bleeding risks, but at this time drug is still in wide use in the United States.
National Xarelto Lawyers Offer Free Case Review
Our attorneys handling Xarelto bleeding lawsuits on behalf of individuals and their family members who suffered from severe internal bleeding or hemorrhaging while taking Xarelto. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or a loved one suffered from severe internal bleeding or hemorrhagic stroke while taking Xarelto, a Xarelto bleeding attorney can help by answering your questions and giving you a sense of your legal options.
Persons who suffered from or died as a result of severe bleeding or hemorrhagic stroke while taking Xarelto may have grounds for a Xarelto bleeding lawsuit. We provide legal representation for Xarelto lawsuits on a contingency basis, meaning that we never charge a fee unless we win compensation on your behalf.