FDA is Alerting Patients and Health Care Professionals About the Voluntary Withdrawal of Oxbryta from the Market Due to Safety Concerns

September 26, 2024 – The FDA is alerting patients, caregivers, and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns.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.

In postmarketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease receiving Oxbryta compared to placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these postmarketing studies. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies.

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.

Source: FDA

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