FDA Reviews New Xarelto Dosage Amid Growing Lawsuits
Regardless that the blood thinner harmed thousands from bleeding events caused by the medication, it may soon be available in another Xarelto dosage. The FDA granted a priority review of Janssen Pharmaceutical’s supplemental new drug application. This means that the FDA and the manufacturer could care less that the blood thinner causes internal bleeding. Instead, they are paving the way for more people to experience these dangerous side effects.
is a blood thinner, or anticoagulant, which came on the market in 2011. It is a huge financial success and created a new generation of anticoagulant medication. Despite its short time on the market, Xarelto may already be responsible for hundreds of patient deaths. The Food and Drug Administration has linked Xarelto to 2,081 serious complications and 1,121 deaths.
These incidents involve serious and potentially unstoppable bleeding due to the drug’s method of action: preventing the blood from clotting.
By stopping the blood from clotting, blood-thinners can prevent blood clots in people suffering from conditions such as atrial fibrillation. Due to the risk of unstoppable bleeding, researchers developed an “antidote” to stop this effect in the case of emergency in users of warfarin, the most popular anticoagulant for decades.
Xarelto users aren’t so lucky. There is no antidote to reverse the anti-clotting effect of Xarelto in an emergency. This means doctors and surgeons may have limited options. It means that what could be a treatable injury for most people can be a fatal one for Xarelto users.
Some of the potentially fatal conditions Xarelto users have suffered include gastrointestinal bleeding, brain hemorrhaging, kidney bleeding, rectal bleeding and other internal bleeding events.
More than 17,000 Pending Xarelto Lawsuits
More than 17,000 Xarelto lawsuits are now pending and centralized in the U.S. District Court, Eastern District of Louisiana. Victims insist that since Janssen pushed Xarelto as superior over safer warfarin, the manufacturer is responsible for their injuries. Janssen knew there wasn’t an antidote and didn’t adequately test Xarelto prior to releasing it to the public. This means Janssen failed to warn the public about all the deadly side effects of the drug. If the victims knew all the dangers, they could have had regular blood tests to ensure doctors were giving them the proper dosage.
Just two Xarelto lawsuits have gone to trial in Louisiana, both of which ended with defense verdicts. A third case will go to trial on August 7th in the U.S. District Court, Southern District of Mississippi.
Speak to an Attorney Today
If you or a loved one experienced a bleeding event from Xarelto, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.