Prescription Drugs

Next year, the first of more than 800 lawsuits against the manufacturers of the blood thinner Xarelto is expected to begin in Philadelphia, Pennsylvania. The plaintiffs and their attorneys claim that the injuries suffered from taking the drug are due to Janssen Pharmaceuticals and Bayer failing to warn them of the increased risks when the drug is only taken once a day.

Gastrointestinal and Cranial Bleeding

The litigants in the Xarelto federal multi-district litigation alleged that there is an increased risk for gastrointestinal and cranial bleeding when the drug is only taken once a day –- something that manufacturers marketed heavily.

According to one of the MDL attorneys, two of the Phase II studies showed that when Xarelto was only taken once a day, there were “higher maximum plasma concentrations and lower trough plasma concentration.” The attorney also said, “It’s not hard to see how those kinds of fluctuations can both increase the risk of bleeding when concentrations are high and make the drug less effective for preventing clots when the concentrations are low.”

In a Phase III study, there was a comparison of taking the drug once a day and twice a day. The same attorney referred to the results of that trial as “a total mess” and “an elementary school science fair project.” The Food and Drug Administration also inquired about those issues during the drug’s approval process.

Manufacturers Stand by Xarelto Clinical Study Results

A Janssen Pharmaceuticals’ spokesman provided a statement on behalf of the company, which was in sharp contrast to the attorney’s remarks. The statement said, “Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots. After more than four years on the U.S. market, and more than 3 million patients prescribed in the U.S. to date, the benefit-risk profile of Xarelto remains favorable and consistent with clinic trials.” In addition, he said that Janssen has “always” warned of the risks of bleeding with Xarelto. The spokesman said that when both dosages were studied, the once-daily dosing was shown to be appropriate for most patients.

What You Can Do if You Have Suffered Harm as a Result of Xarelto

If you or a loved one have suffered because of the drug Xarelto, you may be able to seek compensation. To learn more about your legal options, contact a local Xarelto attorney.