On Thursday, the U.S. Food and Drug Administration (FDA) began to alert patients, caregivers and healthcare professionals about Pfizer’s voluntary withdrawal of OXBRYTA.
The withdrawal comes after postmarketing studies showed that the risks of side effects were greater than the benefits.
OXBRYTA, also known as voxelotor, is used as a treatment for sickle cell disease. Still, the studies reported a higher rate of severe pain caused by sickled red blood cells blocking blood flow and oxygen to tissues, the FDA wrote in a press release.
The FDA is urging patients taking to the medication to stop using it and consult with their doctor about alternate treatment options.
“The safety and well-being of patients is of the utmost importance to Pfizer, and we believe this action is in the best interest of patients,” said Aida Habtezion, Chief Medical Officer and Head of Worldwide Medical and Safety at Pfizer. “Our primary concern is for patients who suffer from SCD, which remains a very serious and difficult-to-treat disease with limited treatment options. We advise patients to contact their physicians to discuss alternative treatment while we continue to investigate the findings from our review of the data.”
In 2019, the FDA fast-tracked the approval of OXBRYTA, based on intermediate clinical data.
“FDA understands the importance of having safe and effective medications available to improve the health of patients living with this rare, serious disease,” the FDA wrote. “There are other FDA-approved medications for the treatment of sickle cell disease, which health care professionals may prescribe as an alternative treatment to Oxbryta.”
Pfizer Inc. has pulled OXBRYTA from the market, stopped distribution and discontinued all clinical trials and programs.
Patients, physicians, pharmacists, or other healthcare professionals with additional questions about OXBRYTA should contact Pfizer Medical Information 1-800-438-1985.