Despite Bayer and Johnson & Johnson’s best efforts, the money-maker blood thinner Xarelto has been denied the freedom to expand its use. The manufacturers were seeking to expand the blood thinner’s approved uses to include heart attacks and strokes, and death, in patients with acute coronary syndrome (ACS), along with clogging of heart stents. The FDA denied that approval earlier this year, according to Reuters.
“Drug manufacturers are often hungry for expanded uses for their drugs,” commented Ned McWilliams, a partner with the Levin, Papantonio law firm who practices in the areas of Mass Torts, product liability, and bad drug litigation. “Often, they fail to disclose the dangers associated with their products in order to get the approval they need from the FDA. By doing so, they fail to inform not only the FDA but the patients that use their devices and rely on the information that they have been provided.”
A number of lawsuits have been piling up against the manufacturers claiming injuries related to the pill, including severe internal bleeding. There is currently no antidote for Xarelto, and the companies have yet to distribute information to doctors about how to counter the drugs potentially life-threatening bleeding effects.
Developed to replace the blood thinner Warfarin, Xarelto manufacturers claim that the drug requires less administrative overhead than Warfarin. However, should a patient’s level of Warfarin become too high, a dose of vitamin K could counteract Warfarin’s effect. No such counter exists for Xarelto. Patient’s are left to wait until the drug is filtered from the blood by natural processes.
“We expect many more lawsuits to be filed against the manufacturers of Xarelto,” Mr. McWilliams added. “This story is far from over.”