FDA Warning, Action or Recall: The U.S. Food and Drug Administration review process concluded that Xarelto discontinuation may be associated with a dangerous rebound effect. This resulted in a FDA Black Box Warning of an increased risk of thrombotic events when some patients stop taking the drug. The current Risk Evaluation and Mitigation Strategy is to inform healthcare professionals that discontinuing the drug without introducing an alternative anticoagulant places some patients at an increased risk of stroke and other dangerous medical conditions.
The personal injury attorneys at Todd E. Copeland & Associates continue to follow both the individual lawsuits being filed as well as the possibility of mass tort litigation for patients who had adverse effects after taking the drug. Our personal injury lawyers suspect that victims may be able to take legal action in light of claims that the manufacturer aggressive pushed for off label uses and failed to adequately warn healthcare providers (and patients) about the serious risk of excessive bleeding and sudden discontinuation. If you or a loved one suffered uncontrolled bleeding or death, you should contact our law office for a free consultation.
What is Xarelto Prescribed to Treat?
Considered to be one of the new generation of blood thinners (along with Pradaxa), Xarelto has been approved to treat a limited variety of conditions. It is basically used as an alternative to Warfarin to reduce the risk of blood clots in patients with an irregular heartbeat (atrial fibrillation) not caused by a heart valve problem; it is also prescribed to treat deep vein thrombosis and pulmonary embolism; and it is an option for reducing the risk of blood clots in patients who have just had knee or hip replacement surgery. People with an irregular heart beat are at greater risk of stroke and should not stop taking Xarelto without talking to the prescribing physician. Patients taking the drug who receive spinal anesthesia should be closely monitored for symptoms of spinal or epidural blood clots.
Symptoms and Side Effects
Xarelto is an anticoagulant that can have dangerous side effects including uncontrollable bleeding. It is similar to the drug Pradaxa, which has also come under recent scrutiny for excessive bleeding events. Signs and symptoms that require medical attention include:
- Unexpected or Unusual Bleeding
- Severe Bleeding You Can't Control
- Red, Pink or Brown Urine
- Vomit Blood or Vomit that Looks Like Coffee Grounds
- Bright Red or Tar-like Black Stools
- Headaches, Dizziness or Muscle Weakness
The new generation of drugs that were marketed to reduce the number of symptoms and side effects are now considered to have just as high a risk for bleeding as the drugs they replaced, with one important difference. Neither Xarelto nor Pradaxa have an antidote or reversal agent that can be administered to stop uncontrollable bleeding.
The manufacturer (Bayer) and (Jannsen Pharmaceuticals) may have opened the door to future litigations by attempting to increase their profits by getting Xarelto approved for new uses (which were recently denied by the FDA). In addition, there is a growing debate in regards to the failure to provide adequate warnings about a sudden discontinuation of use. If you or someone you love was hospitalized with severe bleeding or experienced an adverse effect (or succumbed) following discontinuation of the drug, you should seek immediate legal counsel. Contact us at (407) 999-8995 or toll free at (888) 999-9149 to learn more about a Xarelto lawsuit.