The Food and Drug Administration must approve all drugs before they can be sold in the American marketplace. The review process for approval is lengthy, but drug companies have a lot at stake. The FDA has recently come under fire for approving the anticoagulant drug Xarelto, despite some misgivings during the trial process.
An FDA staff review found that the study used to gain FDA approval of the drug Xarelto was biased in favor of the drug.
Over the objections of scientists that had been assigned to study the drug’s effectiveness, the FDA approved the drug Xarelto in 2011. Since then, the company has been hitting the commercial airwaves, utilizing celebrity spokespeople to sell the drug.
The study showed that patients taking Xarelto may be at higher risk for stroke or a bleeding event than they would be if they had been skillfully taking Xarelto’s primary competitor: Warfarin.
Critics of the study allege that the studies were conducted in such a way to skew the information towards the side of Xarelto. Some allegations include that the control group given warfarin was managed poorly and that while the half-life of Xarelto inside the body is half-a-day, but participants were only given once-per-day doses. Even when the FDA rejected the plan to test once-per-day doses, trails went ahead at this dose. This is primarily because of the appeal of once-per-day medications.
In 2014, Xarelto was named in some 3,331 “serious” complaints regarding complications while taking the drug. Sadly, 379 of these cases led to the death of the patient. When it comes to complaints made directly to the FDA, Xarelto led all other therapeutic drugs with 525 reports.
More than 3,000 patients have filed lawsuits against the manufacturer of the drug.
If you or someone you know has suffered injury or adverse events as a result of the prescribed drug Xarelto, contact the law offices of John Foy & Associates. Our attorneys will work with you to get you the compensation that you deserve. Contact us today.