Xarelto, a blood thinner linked to irreversible hemorrhaging and other serious medical problems, is now under investigation for problems that may have occurred during the FDA’s initial testing of the drug. The FDA is investigating whether a device used during clinical tests may have negatively affected test results by understating the bleeding risk of patients. Contact a Boston Defective Medical Equipment Lawyer Today.
Xarelto quickly grew in popularity following its approval by the FDA in 2011. The anticoagulant, which is billed as a low-maintenance alternative to warfarin, is prescribed to patients at risk of blood clots and stroke. Up until recently, warfarin was the only option for patients suffering from these types of conditions. Warfarin requires frequent blood monitoring, an inconvenience that Xarelto patients don’t have to endure. Both warfarin and Xarelto have a risk of excessive bleeding, but there’s one major difference between the two. Warfarin-related bleeding problems have an antidote; a dose of fresh blood plasma and vitamin K, administered by a physician. Unfortunately, no antidote exists for patients who experience hemorrhaging while undergoing Xarelto treatment. This oversight has resulted in thousands of injuries and deaths.
Was there Evidence that the Device was Malfunctioning During Clinical Trials?
Until recently, the FDA’s spotlight was on the drug itself. However, new evidence indicates that a malfunctioning device during clinical trials may be to blame for the injuries and deaths. According to a recent article in the New York Times, the FDA has recently begun asking Xarelto’s manufacturer, Johnson & Johnson (Janssen), “…detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.”
The article also reported that, “Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.” It was indicated that Johnson & Johnson (Janssen) and Bayer reportedly, “…notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding.”
Potentially Life-Threatening Medical Conditions Linked to Xarelto
- Excessive bleeding
- Uncontrolled bleeding
- Pulmonary embolism
- Deep vein thrombosis
- Gastrointestinal hemorrhaging
- Decrease in hemoglobin
- Cerebrovascular problems
- Peripheral edema
- Hematoma
- Dyspnea
Altman & Altman, LLP – Defective Medical Product Lawyers Serving Boston and the Surrounding Areas
With more than 50 years’ experience protecting the rights of accident and injury victims throughout Massachusetts, the lawyers at Altman & Altman, LLP have the knowledge and experience you need to win your case. If you have been injured due to the negligence of a medical product manufacturer, healthcare provider, or pharmaceutical company, we can help. When companies place profits above the health and safety of patients, they should be held accountable. You may be entitled to compensation for medical expenses, pain and suffering, lost wages, and other associated costs. Our talented and compassionate legal team will be by your side throughout the entire process. Don’t go through this alone. Contact Altman & Altman, LLP for a free and confidential consultation today.