Despite Potentially Deadly Side Effects, Manufacturers Seek to Expand Xarelto Use

The manufacturers of the blood-thinning drug Xarelto are seeking to expand the approved uses of the drug despite documented dangers. Bayer and Janssen-a subsidiary of Johnson & Johnson-were denied approval earlier in 2014 when they applied to expand the use of Xarelto to include patients with acute coronary syndrome and clogging of heart stents. This was the third rejection by the FDA for an expanded use of Xarelto. Xarelto is currently approved by the FDA only for use in preventing or treating deep vein thrombosis or pulmonary embolism. Patients undergoing a knee or hip replacement may also be prescribed Xarelto as a means of preventing blood clots.

Financial Greed Trumps Patient Safety

The aggressive push to expand the use of Xarelto despite the growing number of lawsuits being filed across the nation has to do with nothing more than financial greed. While Xarelto has been on the market for a relatively short period of time (the drug was introduced in late 2011), it has closed in on blockbuster status. Sales of Xarelto are expected to top $1 billion by the end of 2014, and FDA approval for expanded uses of the drug could only boost sales further.

What's the Problem with Xarelto?

Xarelto has been identified as the cause in a number of fatal and near-fatal bleeding incidents. Older blood thinning drugs like Warfarin and Coumadin have been prescribed since the mid- 1950's, yet because the patients taking those drugs must be monitored regularly and because the drugs have certain food and drug interactions, many doctors are prescribing Xarelto and similar drugs (Pradaxa) as an alternative. Xarelto can be prescribed in a more standardized dose which is not dependent on the patient's age or weight, requires no regular blood monitoring and has no known food or drug interactions.

While this all sounds great, Xarelto has one very serious side effect the older drugs do not. If a patient suffers an uncontrollable bleed while taking Warfarin, doctors can administer a shot of Vitamin K, which reverse the effects of the drug. Xarelto has no such reversing agent; when a patient suffers an uncontrollable bleed, doctors can do nothing other than transfusing blood to the patient and hoping the bleeding will stop on its own.

Black Box Warnings on Xarelto

The Xarelto labeling does include two black box warnings although neither are related to uncontrollable bleeding. In 2012, fifty-eight deaths were attributed to Xarelto use and in 2013, another 72. Current lawsuits claim Xarelto is unreasonably dangerous and that the manufacturers have failed to adequately warn patients of the potential risks of gastrointestinal bleeding, rectal bleeding, brain hemorrhage, and other uncontrollable bleeds. Further, the FDA has cited Xarelto manufacturers for distributing promotional materials which were misleading or completely false.

It is not clear just how many lawsuits have been filed against the manufacturers of Xarelto, although less than two weeks ago a group of 21 consumers petitioned the U.S. Judicial Panel on Multidistrict Litigation to combine their lawsuits into a single case. MDL status is often granted when the facts of the individual cases are very similar. Despite the last three FDA rejections, Bayer, Janssen and Johnson & Johnson intend to continue to push for expanded uses of Xarelto, and have announced three new clinical trials to prove the drug can be used to combat ACS and other problems. Those harmed by Xarelto could benefit from speaking to a knowledgeable product liability attorney.

National Dangerous Drug Lawyers

If you have suffered medical complications, pain, or excessive bleeding after using Xarelto, your injuries may be the result of a drug manufacturer’s negligence. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.