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CENTER FOR DRUG EVALUATION AND RESEARCH
DIVISION of
DRUG INFORMATION
Your source for the latest drug information. Know the moment it happens.
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FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
FDA is alerting patients, caregivers, and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns. Health care professionals should stop prescribing Oxbryta. Patients and caregivers should contact their health care professional about stopping Oxbryta and starting another treatment option.
Pfizer Inc., the manufacturer of Oxbryta, announced it is voluntarily withdrawing the medication from the market, ceasing distribution, and discontinuing all active clinical trials and expanded access programs for Oxbryta because recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.
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