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FDA

Oxbryta (voxelotor) to be withdrawn from market due to safety concerns

September 26, 2024

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Oxbryta (voxelotor) is being voluntarily withdrawn from the market by Pfizer due to safety concerns, FDA announced. Postmarketing clinical trials showed a higher rate of vaso-occlusive crisis as well as more deaths in patients with sickle cell disease receiving Oxbryta vs. placebo. The manufacturer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving the drug in two real-world registry studies. Based on the totality of clinical data, Pfizer determined the benefit of Oxbryta doesn't outweigh the risk. Tap for more details ...

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