Oxbryta (Voxelotor) Withdrawal Lawsuit

What Pfizer withdrew — and why

On September 25, 2024, Pfizer voluntarily withdrew all lots of Oxbryta (voxelotor) from every market where it was sold — the United States and more than 35 other countries — and halted its ongoing voxelotor clinical trials and expanded-access programs worldwide. Oxbryta was the first FDA-approved medicine designed to directly inhibit the sickling of red blood cells in sickle cell disease. Pfizer said the decision rested on the totality of clinical data, which by then pointed to an imbalance in vaso-occlusive crises and fatal events — the very complications the drug was meant to reduce. In the company’s words, the overall benefit of Oxbryta “no longer outweighs the risk in the approved sickle cell patient population.”

The clinical data behind the withdrawal

The warning signs came from Pfizer’s own post-marketing studies and real-world registries. In two Phase 3 post-marketing trials, more patients taking Oxbryta had vaso-occlusive crises — the painful, dangerous blockages of blood flow that define a sickle cell crisis — than patients on placebo, and more patients in the Oxbryta groups died. In the GBT440-032 study (HOPE Kids 2), which enrolled children at high risk of stroke, eight children taking voxelotor died compared with two on placebo. In a second trial, GBT440-042 (RESOLVE), eight deaths occurred among patients on voxelotor. European regulators disclosed that sixteen patients had died across the trials; many of the deaths involved infections such as malaria and sepsis. Two independent registry studies showed the same troubling pattern of increased vaso-occlusive crises.

What Oxbryta was supposed to do

The FDA first cleared Oxbryta in 2019 under its accelerated-approval pathway for patients 12 and older, and expanded it in December 2021 to children as young as four. Accelerated approval let the drug reach the market based on a surrogate measure — its ability to raise hemoglobin levels — rather than proof that it reduced the crises, organ damage, and early deaths that sickle cell disease causes. The withdrawal five years later became a widely cited example of the risk in approving drugs on surrogate endpoints alone: a medicine can improve a lab number while failing, or even harming, the patients it was meant to help.

Who may have a claim

People’s Justice is investigating potential claims on behalf of sickle cell patients — and the families of patients who died — who took Oxbryta. You may have a claim worth investigating if:

• You or a loved one was prescribed and took Oxbryta (voxelotor) for sickle cell disease.
• During or after taking it, you or your loved one suffered a vaso-occlusive crisis, stroke, organ damage, or another serious complication — or a loved one died.
• The injury or death falls within the timeframe your state’s statute of limitations allows for a product-liability or wrongful-death claim.

Why the withdrawal itself is powerful evidence

Most drug-injury cases turn on a hard question: did the medicine actually cause the harm? Oxbryta is unusual. Pfizer — the company that sold the drug — pulled it from every market worldwide after its own studies showed more crises and more deaths among patients who took it. A manufacturer’s voluntary global withdrawal, grounded in its own clinical data, is exactly the kind of admission that plaintiffs in most drug cases spend years trying to establish. That does not guarantee any individual outcome — causation still has to be shown patient by patient — but it gives these claims an unusually strong foundation.

Where the litigation stands

Individual product-liability and wrongful-death lawsuits have been filed against Pfizer and Global Blood Therapeutics, the company that developed voxelotor and was acquired by Pfizer in 2022. Plaintiffs’ attorneys are pursuing coordination of the cases, though no federal multidistrict litigation had been formally established as of mid-2026. Because sickle cell disease disproportionately affects Black Americans, the litigation has drawn particular attention to how a therapy marketed to an underserved community reached the market and stayed there. People’s Justice is not a law firm and does not provide legal advice — we investigate potential claims and connect people who may qualify with independent attorneys who handle pharmaceutical-injury cases. Every case is different, and no result is ever guaranteed. Our reporting here draws on Pfizer’s own withdrawal announcement, the FDA’s safety alert, disclosures from European regulators, and guidance from the Sickle Cell Disease Association of America.