Oxbryta (voxelotor) was the first FDA-approved medicine designed to stop red blood cells from sickling in people with sickle cell disease — cleared in 2019 and expanded to young children in 2021. On September 25, 2024, Pfizer voluntarily withdrew every lot of Oxbryta from markets worldwide. Its own post-marketing trials and registries had revealed an imbalance in vaso-occlusive crises and deaths: patients taking the drug were suffering more of the crises it was meant to prevent, and more of them were dying. A manufacturer pulling its own drug from the global market based on its own safety data is a rare and powerful foundation for the product-liability and wrongful-death claims now emerging.
From the docket
Litigation Timeline
- September 2024
Pfizer withdraws Oxbryta worldwideregulatory
Pfizer voluntarily withdraws all lots of Oxbryta from markets worldwide and halts its voxelotor trials, citing clinical data showing an imbalance in vaso-occlusive crises and deaths. The FDA tells doctors to stop prescribing it.
- December 2021
FDA expands Oxbryta to children as young as fourregulatory
The FDA broadens Oxbryta’s approval to include children aged 4 to 11, widening the population of sickle cell patients prescribed the drug.
- November 2019
FDA grants accelerated approval to Oxbrytaregulatory
The FDA approves Oxbryta (voxelotor) under its accelerated-approval pathway for sickle cell patients aged 12 and older, based on the drug’s ability to raise hemoglobin levels — a surrogate endpoint rather than proof of fewer crises or deaths.
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