Oxbryta (voxelotor) was withdrawn from the market worldwide in September 2024 after post-market data showed increased vaso-occlusive crises and deaths — patients who relied on the drug allege they were harmed or left without warning.
Oxbryta (voxelotor) was approved in 2019 under the FDA's accelerated approval pathway to treat sickle cell disease. It was marketed as a breakthrough therapy that reduced red blood cell sickling and anemia.
In September 2024, Pfizer voluntarily withdrew Oxbryta from all markets after post-approval clinical data showed an imbalance in vaso-occlusive crises and deaths compared to placebo. The FDA and European regulators confirmed the withdrawal, and patients were told to stop taking the drug and consult their physicians.
Claims allege patients experienced increased pain crises, organ complications, and other harm while taking the drug — and that serious safety signals were not adequately communicated before the withdrawal. Litigation is in early stages.
Oxbryta was withdrawn globally in September 2024. Litigation is in early stages — claims are being evaluated and filed as the scope of injuries connected to the drug becomes clearer.
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