The FDA has issued an alert to patients, caregivers, and healthcare professionals about the voluntary withdrawal of Oxbryta (voxelotor) from the market due to safety concerns. Pfizer, the manufacturer, has stopped the distribution of the drug and discontinued all clinical trials after data showed an increased risk of vaso-occlusive crises (painful episodes in sickle cell disease) and a higher mortality rate among Oxbryta patients compared to those on placebo.
Initially approved under the FDA’s accelerated approval pathway in 2019, Oxbryta was intended to treat sickle cell disease in adults and children. However, postmarketing studies revealed that the risks outweighed the benefits for this patient population. The FDA is continuing its review of safety data and advises healthcare providers to discontinue Oxbryta and consider other approved treatments for sickle cell disease. Patients should consult their healthcare professionals for alternative options