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Xarelto Antidote Delayed by FDA

By George Khoury, Esq. | Last updated on

While the number of Xarelto lawsuits continues to increase, the FDA issued a response to Portola Pharmaceuticals, makers of the potential Xarelto antidote, AndexXa. The FDA has requested more information which will delay the release of the antidote to the public.

The manufacturer of the anti-clotting drug, Xarelto, has been sued by over 7,000 individuals as a result of an alleged failure to warn users of the side-effects. Additionally, the drug has no antidote to immediately reverse the anti-clotting effect it has on the blood. In comparison, the leading anti-clotting drug, known as warfarin, stops being effective when a patient is injected with vitamin K. The antidote's approval is being expedited due to the urgent need for a way to reverse the effects of Xarelto.

Can a Pharmaceutical Company Be Sued Even After FDA Approval?

While one might think that the FDA's approval is as good as gold, they would be right for likely the wrong reason. When the FDA approves a drug, it just means that the drug can now be sold as a drug and the company can start profiting. When the FDA approves a drug or product, all they are really saying is that the product's benefits outweigh the risks.

While the FDA may have been aware of some of the risks when the drug was approved in 2011, a quick glance at their information page for the drug shows numerous updates since that time.

What's the Xarelto Lawsuit Claiming?

Patients taking Xarelto have died or become seriously injured as a result of taking the drug. Studies have shown that those taking the drug are more than twice as likely to experience stomach bleeding, compared to patients prescribed to take another anti-clotting medication. The many lawsuits facing the manufacturer are based upon the assertion that the manufacturer knew certain side effects existed, but did not tell the public. An additional claim against the manufacturer is that they knew the drug was not safe, yet continued to offer it for sale on the market.

These claims suggest what many people already know: FDA approval of a drug does not necessarily mean that a drug is safe. If you've been injured by the drug, contact an attorney immediately as there are strict filing deadlines that could defeat your claim if missed. If you want to be part of the large Xarelto class action lawsuit, the deadlines are even stricter.

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