Xarelto & Dangerous Internal Bleeding
Xarelto was introduced to the United States in 2011 as a blood-thinning medication to prevent clots from forming in people who have atrial fibrillation and to reduce the risk of clots following hip or knee replacement surgery. While it’s been promoted as safe and effective, a growing number of reports show that the side effects of Xarelto can lead to serious bleeding, hemorrhages and even death.
The generic name of the drug is rivaroxaban, but it is marketed as Xarelto in several countries including the United States. The drug was developed by Bayer and Johnson & Johnson’s Janssen Pharmaceutica subsidiary as a replacement to warfarin with a differentiation that unlike its predecessors, Xarelto requires no blood monitoring and is the first to offer once-daily dosing.
Xarelto works by inhibiting an enzyme in the blood that causes clotting. However, there’s no way to reverse the blood thinning effects, so stopping, controlling or reversing a user’s bleeding is not possible.
Because Xarelto is an anticoagulant, the side effects of the drug include easy bruising, minor bleeding and a longer time needed for bleeding to stop. In some people, however, the drug has led to serious, uncontrollable internal bleeding and hemorrhaging. Signs of serious bleeding include:
- Unusual pain, swelling or discomfort
- Unusual bruising
- Prolonged bleeding from cuts or gums
- Persistent or frequent nosebleeds
- Unusually heavy or prolonged menstrual flow
- Pink or dark urine
- Coughing up blood
- Vomit that appears bloody
- Severe headache, dizziness or fainting
- Unusual or persistent tiredness or weakness
- Bloody, black or tarry stools
- Difficulty swallowing
Since its release, the U.S. Food and Drug Administration (FDA) has issued new requirements for Xarelto’s labeling and advertising to address some of these concerns. In 2013, the FDA determined the drug’s print advertising was misleading, downplaying the drug’s side effects, and in 2014, Xarelto had to update its safety communications that the FDA had found did not adequately warn of the risks and dangerous side effects of the drug.
Although there is a now a black box warning on the drug’s label addressing the risks of the drug, some feel the label still does not adequately address gastrointestinal bleeding and hemorrhaging. The makers of Xarelto continue to push to expand the use of the drug by conducting clinical trials with children, people with peripheral artery disease, patients with cancer and certain autoimmune diseases and more.
As of April 2018, nearly 22,000 lawsuits have been filed against Bayer and Johnson & Johnson alleging injuries and wrongful deaths from users of the drug due to severe bleeding. If you have been injured or a loved one has died because of taking the prescription drug Xarelto, you should take prompt legal action to protect your right to compensation for pain and suffering, medical expenses, lost employment income and more. Talk to a leading personal injury lawyer at Roberts & Roberts about your rights if Xarelto has turned your life upside down.