Higher Death Rates Prompt Pfizer to Withdraw Medication Over Serious Safety Concerns

Photo of different pills for illustrative purposes onlyPhoto bypina messinaonUnsplash

The FDA has issued an alert regarding Pfizer's voluntary decision to withdraw its drug Oxbryta (voxelotor) from the market due to health risks. Health care professionals have been advised to stop prescribing the medication, and patients are urged to consult their doctors about alternative treatments.

Pfizer's decision comes after postmarketing studies revealed an increased risk of vaso-occlusive crises—painful events caused by sickled red blood cells blocking blood flow—in patients with sickle cell disease taking Oxbryta. The company also noted a higher death rate among Oxbryta users compared to those on a placebo. Given these findings, Pfizer determined that the drug's risks outweigh its benefits.

Originally approved in 2019 for patients 12 and older, and later for children ages 4-11 under the FDA's accelerated approval program, Oxbryta had been seen as a promising treatment for sickle cell disease. However, postmarketing trials and real-world studies led Pfizer to discontinue all distribution, clinical trials, and expanded access programs for the drug.

The FDA is currently conducting its own safety review of the postmarketing data and will provide further updates if needed. In the meantime, other FDA-approved treatment options are available for patients with sickle cell disease.

Health care professionals and patients are encouraged to report any adverse effects related to Oxbryta through the FDA's MedWatch Adverse Event Reporting system.