The Botched Xarelto Studies

A Cover-Up

The manufacturers of the blood-thinning medication Xarelto have come under serious scrutiny due to an alleged cover-up of the lethal side effects Xarelto can cause. In fact, at five clinical trial sites, the U.S. Food and Drug Administration found that researchers did not report adverse side effects caused by the drug and failed to keep adequate medical records.

Other trials were so poorly conducted that the FDA failed to consider the trials entirely. One study known as RECORD 4 was particularly riddled with so many violations and departures from clinical practice that the results were rejected outright. RECORD 4 included issues such as the "systematic discarding of medical records," falsification and "concerns regarding improprieties in randomization."

The FDA Approved Xarelto Anyway

Even with the mounting evidence concerning how the studies were conducted, the FDA ultimately approved Xarelto in 2011. The drug has been strongly promoted by doctors as a convenient alternative to warfarin, Xarelto's older counterpart. Not surprisingly, Xarelto, while convenient, causes serious side effects, including internal bleeding. Because of the misconduct involved in the approval process and the irreversible side effects caused by the drug, patients and their loved ones are now filing lawsuits all over the country.

Contact Us For Help

If you suffered a serious bleeding injury from using Xarelto or if someone in your family suffered fatal bleeding after using Xarelto, contact one of the attorneys at Reich & Binstock in Houston for a free consultation. Call us at 713-352-7883 or 877-643-3099 toll free, or write to us online for more information.