Johnson & Johnson, Bayer, and Janssen Pharmaceuticals may be contributing to numerous injuries since introducing their blood thinner, Xarelto, to the public in 2011. They have aggressively marketed this drug, perhaps downplaying its risks in the process. These risks may include an increased danger of bleeding, and the fact that there is currently no known agent that can reverse the anticoagulant effects of the medication. Xarelto has no antidote.
People, who claim to have suffered severe injuries while taking Xarelto, have filed lawsuits, and more continue to do so. Patients claim that they suffered significant injuries from Xarelto, which were made worse because doctors could not control their bleeding. There are also claims that loved ones died because of this uncontrollable hemorrhaging. If you or a family member have experienced anything like this while taking Xarelto, Farris Riley & Pitt are available to assist you. Our Birmingham, Alabama attorneys can help determine if you are entitled to compensation for your injuries.
Xarelto Inadequate Warnings
Every single medication comes with warnings of some kind. We all hear the commercials for various drugs and the long list of possible side effects and complications that may occur. The Food and Drug Administration (FDA) closely regulates the content of these warnings and how manufacturers must share them with the public.
Xarelto is no different. It contains many warnings about the risks associated with taking the medication such as easy bruising or dizziness. Like all anticoagulant drugs, the warnings state that taking Xarelto may increase the risk of bleeding. At various times after its distribution and marketing, however, the FDA determined that Janssen did not provide adequate or proper warnings to its patients.
In response to adverse reports, the FDA ruled that Janssen must change the label to reflect the true dangers of Xarelto. In other words, they did not prominently or clearly display the risks on the warning label. The FDA required that Janssen make changes that would better disclose the serious risk of bleeding. They also demanded that Janssen warn patients, in an obvious manner, that there is no known way for medical professionals to reverse the bleeding effects of Xarelto. Janssen did not include this information on prior labels.
Xarelto was initially put on the market and prescribed with no “black box” warnings, which are which are those reserved for prescription drugs that pose the most life-threatening risks. The FDA eventually required that Janssen add several of these “black box” warnings. They ordered that Janssen include the risk of stroke or other bleed that can be caused by stopping Xarelto and the danger of suffering a spinal hematoma and paralysis.
Xarelto Bleeding Injuries and Death
Xarelto launched into the marketplace in 2011. Janssen pharmaceuticals, a subsidiary of Johnson & Johnson and Bayer worked together to create and market it. They touted the virtues of Xarelto and declared that it was a better anti-coagulant than warfarin, which has been the blood thinner of overwhelming choice for at least 50 years. Warfarin requires frequent monitoring and a strict dosing analysis. Xarelto, according to the manufacturer, requires neither of these.
The companies marketed Xarelto aggressively to both consumers and medical professionals. Perhaps in their attempts to quickly and effectively gain a larger share of the anticoagulant market and give warfarin some new competition, Janssen and Bayer ignored consumer safety. Some people claim that they purposefully withheld important information about the safety of Xarelto. Perhaps they wanted to be sure that doctors and patients would be willing to try the new drug. They did not highlight the fact that while taking Xarelto, unlike warfarin, there is no proven way to stop a hemorrhage or bleed.
Companies are working hard to develop an antidote to Xarelto. As of January 2015, there is still no approved reversal agent. It remains to be seen whether a court of law will determine that the manufacturers acted irresponsibly by releasing and aggressively marketing a drug that had no known antidote, without properly warning anyone. Certainly, the failure to adequately highlight the risks and dangers of Xarelto caused the FDA enough concern that they demanded label enhancements.
Perhaps some of the injuries caused by Xarelto could have been avoided if Janssen and Bayer provided from the start, a complete picture of its risks.
Cases are being filed by patients claiming to have suffered from a variety of bleeding injuries that may have been avoided had they or their doctors known the risks of Xarelto. Other cases claim that the inability for doctors to stop or reverse bleeding while on Xarelto caused injury that lead to death of a loved one. If you fall into either category, Farris Riley & Pitt may be of assistance to you. Our attorneys in Birmingham, Alabama understand the intricacies of pharmaceutical cases. We can help determine if you may be entitled to compensation for your injuries.