Oxbryta Lawsuit
The U.S. Food and Drug Administration (FDA) announced on September 26, 2024, that Oxbryta (voxelotor) is being withdrawn from global markets.
Sickle Cell Disease and Oxbryta (Voxelotor)
According to the FDA, Oxbryta is being withdrawn from the market due to safety concerns. Pfizer Inc., the manufacturer of Oxbryta, announced that recent data suggests the medication’s risks outweigh the benefits. Sickle cell disease (anemia) is an inherited blood disorder that causes abnormal hemoglobin production, resulting in rigid, sickle-shaped red blood cells that can block blood flow. It is estimated that this blood disorder affects roughly 100,000 people in the United States.
In 2019, the FDA approved Oxbryta for sickle cell anemia in adults and pediatric patients 12 years and older under the accelerated approval pathway. Accelerated approval is designed to expedite the availability of drugs that treat serious or life-threatening conditions. In 2021, the FDA granted accelerated approval of Oxbryta for patients aged 4 to 11.
In post-marketing clinical trials, Pfizer reported a higher rate of vaso-occlusive crises (VOCs) – severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues – in patients who took the drug. VOCs are one of the most common complications associated with sickle cell disease. These VOCs cause severe pain that can lead to kidney failure, stroke, and death. Pfizer reported eight deaths in the Oxbryta treatment group compared to two in the placebo group. Pfizer has halted production of Oxbryta (voxelotor) and ended clinical research on the product. It is uncommon for drugs to be withdrawn or recalled.