The U.S. Food and Drug Administration has recommended against the immediate approval of Xarelto, which is Bayer AG and Johnson & Johnson’s anti-clotting drug, as a treatment to prevent strokes in patients with atrial fibrillation. The FDA said data from a late-stage study of more than 14,000 patients, known by the acronym ROCKET, doesn’t make it clear how safe Xarelto is, or whether it’s as effective as the widely-used Warfarin. Xarelto was approved in July for reducing the risk of deadly blood clots in patients getting knee and hip replacements, a small part of the potential patient pool. The approval followed a delay of about two years due to FDA concerns about the “internal bleeding risk.”
FDA officials said that an additional patient study could be done, which would cause a long delay before the drug-makers could again seek approval. Bayer Healthcare already markets Rivaroxaban, a daily pill which works by blocking a clotting protein, in 110 countries around the world. Researchers said Xarelto is one of several experimental drugs being developed as a replacement for Warfarin, a medicine originally derived from rat poison that has been used safely and effectively for seven decades to prevent strokes.
It appears that the newer drugs are all meant to be more convenient than Warfarin. That drug must have its dose adjusted using frequent blood tests, and, potentially, to cause less bleeding. Of the three new drugs, only Xarelto is given once a day, with the other drugs requiring twice-a-day dosing. The Alabama Legislature must take action at the earliest opportunity to address this most serious matter.
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