Pfizer Withdraws Sickle Cell Drug Oxbryta From the Market

Publish Date : 10/01/2024

The FDA is informing patients, caregivers, and health care professionals that the manufacturer Pfizer Inc. is voluntarily withdrawing Oxbryta (voxelotor) from the market due to safety concerns.

This decision follows data showing that the risks, such as an increased rate of vaso-occlusive crisis (severe pain from blocked blood flow) and more deaths in clinical trials, outweigh the benefits for sickle cell patients. Health care professionals should stop prescribing Oxbryta, and patients should consult their doctors about alternative treatments.

The FDA is reviewing the safety data and will communicate any further findings if necessary. Oxbryta had been approved under an accelerated approval pathway since 2019, but the postmarketing studies revealed significant concerns. Other FDA-approved treatments for sickle cell disease are available as alternatives.