Oxbryta (voxelotor) was approved by the Food and Drug Administration (FDA) via an accelerated approval process on November 25, 2019, for the treatment of sickle cell disease in those 12 years of age and older. Two years later in late 2021, the FDA approved Oxbryta being given to those with sickle cell disease as young as 4 years old. 

Oxbryta Recall

On September 25, 2024, Pfizer announced that it would be voluntarily withdrawing (recalling) all lots of Oxbryta. Furthermore, Pfizer announced that it would be discontinuing all clinical trials on Oxbryta. Pfizer noted that it decided to recall Oxbryta because “based on the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.” Specifically, Oxbryta has been linked to vaso-occlusive crises (VOCs) and even death. 

Oxbryta Lawsuit

Contact the Oxbryta attorneys at Nigh Goldenberg Raso & Vaughn today at 202-792-7927 for a free consultation regarding a potential Oxbryta lawsuit.