The Food and Drug Administration (FDA) has launched an investigation to determine if the clinical trial results for the blood clotting medication Xarelto were compromised by faulty blood-testing devices.
The clinical trial was conducted between 2006 and 2010 and included more than 14,000 patients worldwide. It was an important factor in approval from the FDA. Xarelto was a part of a new class of blood thinners that hoped to replace warfarin, a 60-year-old medication that required cumbersome blood tests and monitoring of patients diets.
Questions began to arise about the validity of the trials last fall after Johnson & Johnson and Bayer, manufacturers of the drug, notified regulators that the device used in the trials was recalled in 2014 for providing inaccurate results.
The device is called INRatio, sold by Alere, and was used to help doctors determine if patients were receiving the correct dose of warfarin.
Regulators hope to determine if the devices malfunctioned during the tests and led researchers to give patients the incorrect dose of warfarin, which could have led to more bleeding episodes and would have given an unfair advantage to Xarelto.
Johnson & Johnson has stated that it chose INRatio for the tests because it was approved by the FDA and was easy to use. It said it was not aware of the recall until September, when it promptly notified regulators. The manufacturers maintain confidence in the results of the trial.
Researchers from Duke Clinical Research Institute and the European Medicines Agency published their own analysis of the original study and came to the conclusion that the device did not affect the outcome of the trial.
Federal regulators, however, are not satisfied and say that they still have several unanswered questions.
Xarelto has been a hotly contested drug since it was first approved in 2011. Medical reviewers with the FDA originally recommended against approving the drug over concerns that patients receiving warfarin during the clinical trial were poorly managed.
However, an outside advisory committee voted to approve the drug, though with some reservations. The drug has since become one of the most popular blood thinner medications, bringing in nearly $2 billion in 2015 alone.
That success has not come without controversy. Countless lawsuits have been filed alleging that the drug can lead to serious, life-threatening side effects. Our Xarelto injury lawyers can help you get compensation if you have suffered after taking this medication.