Taking any drug comes with the risk of side effects, and Xarelto, approved in 2011, is no exception. Xarelto is a blood thinner manufactured by Bayer and marketed in the United States by Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals. Its purpose was to prevent dangerous blood clots that can obstruct blood flow to vital organs, and its original benefit was that it was able to be prescribed in one uniform dose (as opposed to older anticoagulants that required specific doses for each individual). Soon after its introduction, however, reports emerged regarding sometimes-fatal outcomes associated with uncontrollable bleeding among its users.
Many patients became aware of the bleeding in a very disconcerting way: they began coughing up or vomiting blood, suffering from headaches, passing red or black stool, or experiencing spinal or epidural blood clots after a spinal tap or epidural. Unfortunately, no antidote or reversal agent exists, and to date, the U.S. Food and Drug Administration (the FDA) is not requiring the manufacturer to remove the drug from the marketplace. The FDA did find that the company did not sufficiently warn consumers about Xarelto’s side effects, but that finding hasn’t stopped Johnson & Johnson and Janssen Pharmaceuticals from continuing to promote the drug as safe.
While the FDA failed to act, however, the judicial system has reacted with gusto. In fact, many lawsuits have been filed both in state and federal courts throughout the U.S. alleging that Bayer and Johnson & Johnson failed to properly warn customers about the potential side effects of the drug. Some lawsuits also allege that the company should have thoroughly investigated potential Xarelto antidotes, which may have allowed doctors to reverse the blood thinning effects of the medication. Many call for a Xarelto recall until that antidote is developed.
Indeed, had Xarelto adequately informed consumers and doctors about the lack of an antidote and the risk of developing hemorrhages, doctors could have prescribed the medication more discriminately and could have monitored patients more intently to evaluate their hemorrhage risk. Xarelto also has a number of additional side effects, including abdominal bleeding, brain hemorrhage, abnormal liver function and reduced platelet levels.
Janssen Pharmaceuticals did issue a voluntary recall of 13,500 bottles of Xarelto last October due to a microbial contamination discovered in a sample. However, the recall appears to have been just due to the contamination issue, and not due to any concerns regarding the drug’s side effects or lack of antidote. In fact, the drugmaker reported that Xarelto sales were $414 million in the third quarter of 2014, up 68% from the same quarter one year ago.
If you have been injured or a loved one has died as a result of using Xarelto, don’t delay. Hold the manufacturer of this drug accountable. Call the skilled attorneys at Brooks Law Group today. We can help determine whether you are entitled to any compensation.