The British Medical Journal, better known as the BMJ, is claiming that Janssen Pharmaceutical withheld key information to the US FDA prior to the pharmaceutical company’s drug approval by the FDA.
The false report may have led to the FDA approval of a drug used by thousands of patients and marketed on television by celebrities as a wonder drug.
According to Drug Watch, “Janssen withheld data about problems with the INRation device from the U.S. Food and Drug Administration, the investigators said. The device monitored patients using warfarin during phase III of the ROCKET AF trial and may have compromised data and patient safety. The FDA used data in this trial to approve Xarelto, now one of the bestselling anticoagulants on the market. In 2015, the drug made close to $2 billion for J&J, according to company reports.”
Xarelto was approved by the FDA in July 2011 to treat patients with deep vein thrombosis in hip and knee replacement patients. Xarelto was approved later that same year to prevent strokes in patients with a common type of abnormal heart rhythm.
Since its market debut, Xarelto’s manufacturers have been faced with more than 11,000 lawsuits filed as a result of complications from internal bleeding. The pharmaceutical company paid $650 million to resolve 4,000 lawsuits about bleeding in 2014.
The 2016 study conducted by David J. Graham and colleagues and published in JAMA Internal Medicine raises concern that Xarelto is associated with increased bleeding and mortality compared to Pradaxa in patients with atrial fibrillation (AF).
This suffering could have been avoided if the manufacturer of Xarelto had not withheld crucial clinical information in order to rush a bad drug to market to increase company profits. Xarelto sales have been a windfall for the pharmaceutical company and its parent, Johnson & Johnson. In 2015 alone, the drug made close to $2 billion in profits. Of course, this was at the expense of the truth and the health and welfare of countless patients and doctors who have been duped into taking this drug by celebrity spokesmen paid by Janssen.