This blood thinner has been linked to dangerous internal bleeding in patients.
Xarelto is a blood thinner manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. The drug was approved by the FDA in 2011, for preventing deep vein thrombosis and pulmonary embolism during and after hip or knee arthroplasty, or replacement surgeries. Essentially, the drug prevents the development of harmful blood clots.
Like any medications, a long list of potential side effects was noted. Xarelto, also known as rivaroxaban, was known to cause an array of side effects including headaches, bowel issues, back pain and respiratory issues to name a few. Unfortunately, it was also discovered that the medication could result in extreme thinning of the blood that could lead to an increased risk of dangerous internal bleeding in patients. This could result in serious injury or death to those who suffered from this side effect.
Critics of the drug argue that the manufacturers may have been aware of the potential dangerous side effect and neglected to adequately warn medical professionals, federal regulators and patients. Instead, the manufacturers repeatedly attempted to receive approval for expanded use of the medication, hoping to market the prescription as a preventative for new heart attacks and stroke for patients who suffer from acute coronary syndrome. A report by Reuters notes that these attempts were repeatedly declined by the FDA.
Xarelto manufacturers accused of conducting questionable clinical trials
A FDA advisory panel that reviewed the requests noted above published a response letter strongly recommending against the approval of Xarelto for these extended uses. An article by Forbes notes that the vote against approval was nearly unanimous, with 10 voting against approval and 1 abstaining. The denial was likely in part to a large portion of missing data from the clinical trial.
The trial in question, Rivaroxaban in Patients with Recent Acute Coronary Syndrome, was published in January of 2012 in the prestigious New England Journal of Medicine. Critics note that the credibility of the study is questionable as it was supported by Johnson & Johnson and Bayer Healthcare, the manufacturers of the drug, with many of the authors receiving compensation from these manufacturers.
Remedies likely available to those injured by Xarelto
Patients and those who lost loved ones due to the use of Xarelto are likely eligible to receive compensation to help cover the costs associated with the injury or wrongful death caused by this medication. Remedies may be available through a product liability suit, allowing the injured to potentially receive compensation to help cover lost wages, medical expenses and, in some cases, pain and suffering awards. Contact an experienced dangerous drugs liability law firm to discuss your options and help better ensure your legal rights and any potential remedies are protected.