FDA
Oxbryta (voxelotor) to be withdrawn from market due to safety concerns
September 26, 2024

Oxbryta (voxelotor) is being voluntarily withdrawn from the market by Pfizer due to safety concerns, FDA announced.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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