Defective Pharmaceuticals · Oxbryta
Oxbryta
Voluntarily withdrawn September 2024 — sickle cell patients & families
Oxbryta (voxelotor) was approved by the FDA in 2019 to treat sickle cell disease. In September 2024, manufacturer Pfizer voluntarily withdrew Oxbryta from the global market after post-approval data showed an imbalance in vaso-occlusive crises and deaths in patients taking the drug compared to placebo. Patients and families are now investigating claims for injuries and wrongful death associated with Oxbryta.
Background
What this litigation is about.
Sickle cell disease is a serious inherited red-blood-cell disorder that predominantly affects Black patients in the United States. Oxbryta (voxelotor) was developed by Global Blood Therapeutics (later acquired by Pfizer in 2022) and received accelerated FDA approval in November 2019 based on hemoglobin improvement — a surrogate endpoint, not clinical outcomes.
In September 2024, Pfizer voluntarily withdrew Oxbryta worldwide after post-marketing and confirmatory trial data showed an imbalance in vaso-occlusive crises (VOCs) and deaths in patients taking the drug versus placebo . A population-level safety finding does not determine the cause of an individual patient’s complication.
Plaintiffs allege that the manufacturer relied on a surrogate endpoint (hemoglobin) to secure and maintain approval while post-approval clinical data suggested serious harm, and that warnings to patients and physicians were inadequate.
Reported injuries
Reported concerns and potential losses.
Increased vaso-occlusive crises
More frequent, more severe pain crises while on Oxbryta.
Organ damage
Damage to kidneys, spleen, or other organs during pain crises.
Stroke
Ischemic events reported in some patients on Oxbryta.
Death
The withdrawal cited an imbalance in mortality in the clinical data.
Individual review
Facts that may be relevant.
You or a loved one was prescribed Oxbryta (voxelotor) for sickle cell disease.
You experienced increased vaso-occlusive crises, organ complications, stroke, or hospitalization while on the drug.
A loved one died while on or shortly after taking Oxbryta.
You have pharmacy and medical records documenting the prescription and complication.
Create a medication and event timeline
A vaso-occlusive crisis occurs when sickled red blood cells obstruct blood flow, often causing severe pain. The diagnosis, severity and possible causes need assessment by the treating medical team.
Sickle cell disease itself can cause serious complications. A medical event during treatment does not by itself establish that a medicine caused it. Discuss medication questions with the treating clinician rather than changing care based on a legal page.
- Keep dispensing histories, dose changes, and prescriber notes.
- Record dates of hospital admissions, pain crises, transfusions, and other significant events before, during, and after treatment.
- Save discharge summaries, laboratory trends, and clinician assessments of possible causes.
- Retain any patient notices and records of discussions about treatment alternatives.
Key events
A timeline of what has happened so far.
Nov 25, 2019
FDA grants accelerated approval for Oxbryta (voxelotor) based on hemoglobin response.
Dec 2021
FDA expands approval to pediatric patients ages 4–11.
Aug 2022
Pfizer acquires Global Blood Therapeutics for ~$5.4B.
Sept 25, 2024
Pfizer voluntarily withdraws Oxbryta worldwide citing an imbalance in vaso-occlusive crises and deaths.
Frequently asked
Questions answered plainly.
This page is for general information only, is not legal advice, and does not create an attorney-client relationship. Case statuses, MDL orders, and settlement terms change; call our office for a current review of your specific situation.
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