Oxbryta Lawsuit: Claims for Sickle Cell Disease Medication Side Effects
If you’ve taken Oxbryta and experienced worsening sickle cell disease symptoms or other complications, you may be eligible to file a lawsuit. The Lanier Law Firm has extensive experience in pharmaceutical liability and a track record of significant wins in similar cases. Contact us today to evaluate your legal options.
Legally Reviewed By: Catherine Heacox
Senior Attorney
- Page Last Updated:
- July 17, 2025
Oxbryta Lawsuit Timeline and Recent Updates
January 20, 2025: In the wake of the Oxbryta recall, legal actions have seen a noticeable increase. Since October, at least four Oxbryta lawsuits have been initiated in California. These include cases filed in superior courts in San Mateo and San Francisco counties and one case brought before the U.S. District Court for the Northern District of California.
November 7, 2024: Illinois resident Tirrell Allen sued Pfizer and Global Blood Therapeutics in California federal court over serious injuries he suffered after taking Oxbryta.
According to the complaint, Allen, 43, started taking Oxbryta in August 2024 to treat his sickle cell disease. Allen began experiencing “debilitating” symptoms, including more frequent vaso-occlusive crises, before suffering a stroke in September.
Allen was still hospitalized when the complaint was filed. He asserts that Pfizer is strictly liable for Oxbryta’s defective design and failing to warn patients of its risks. The complaint also claims negligence, breach of warranty, false advertising, and other counts.
September 26, 2024: The FDA announced that Pfizer initiated a voluntary recall of Oxbryta after studies linked the drug to a higher rate of dangerous side effects and deaths than previously expected. According to the FDA’s notice, the new findings led Pfizer to conclude that “the benefit of Oxbryta does not outweigh the risks” of using the drug to treat sickle cell disease.
August 8, 2022: Pfizer announced an agreement to purchase Oxbryta developer Global Blood Therapeutics Inc. for roughly $5.4 billion, citing its progress in creating treatments for sickle cell disease.
December 17, 2021: The FDA expands its accelerated approval of Oxbryta to include patients aged four to 11.
November 25, 2019: The FDA granted accelerated approval to Oxbryta for patients 12 and older based on its novel potential to treat the root causes of sickle cell disease. An initial trial showed a significant increase in hemoglobin levels among participants’ red blood cells compared to a placebo, suggesting Oxbryta could be a beneficial treatment.
What Is Oxbryta?
Oxbryta is the brand name for Voxelotor, a drug developed by Global Blood Therapeutics (later acquired by Pfizer) to treat sickle cell disease, a hereditary blood disorder affecting millions of people worldwide. The FDA granted Oxbryta accelerated approval in 2019 based on promising trial results that showed potential benefits for patients with sickle cell disease.
What Made the Oxbryta Trial Results So Promising?
The FDA cited its ability to potentially curb the deformation of red blood cells into the “sickle” shape that gives the disease its name. Sickle cells carry oxygen less efficiently through the bloodstream and can obstruct blood flow, leading to painful inflammation called a vaso-occlusive crisis, or VOC.
An early trial showed sizable improvement in hemoglobin levels in participants who took Oxbryta compared to a placebo, suggesting the drug could effectively improve the efficiency of red blood cells.
What Are the Side Effects of Oxbryta?
Initially reported side effects listed for Oxbryta included:
- Headaches
- Nausea
- Fatigue
- Abdominal pain
- Drug hypersensitivity
- Diarrhea
- Rashes
- Fever
Why Was Oxbryta Recalled?
Oxbryta was recalled because later studies linked this drug to higher vaso-occlusive crisis rates, raising the chances of severe pain and inflammation symptoms the drug was intended to counteract. There was also a higher rate of death compared to placebo groups, suggesting a link between Oxbryta and fatal side effects.
After clinical data from postmarketing studies showed that Oxbryta might worsen the sickle cell disease outcomes it was specifically developed to treat, Pfizer voluntarily withdrew the drug from the market in September. It also discontinued its ongoing clinical trials, finding its continued use would create more risk than benefit for patients. Meanwhile, the FDA urges doctors to stop prescribing the drug and patients to stop using it and the European Medicines Agency (EMA) has recommended suspending Oxbryta’s marketing authorization due to ongoing safety concerns.
In light of the recall, harmful side effects from taking Oxbryta have already prompted at least one lawsuit against Pfizer and Global Blood Therapeutics.
What Allegations Are Made Against Pfizer After the Oxbryta Recall?
Following the recall, Pfizer Inc. and its subsidiary, Global Blood Therapeutics, have faced multiple lawsuits alleging that they failed to warn users about the potential risks and severe health complications associated with Oxbryta.
Are You Eligible for an Oxbryta Lawsuit?
You might be able to file a lawsuit if you’ve taken Oxbryta and experienced significant side effects or injuries. If you believe you might have a case, schedule a free consultation with our pharmaceutical liability attorneys today.
Why Choose The Lanier Law Firm for Your Oxbryta Lawsuit?
“We are ready to hold companies accountable for drugs that hold danger but little to no use. It’s unfair to a population already suffering.”
– Mark Lanier, founder of The Lanier Law Firm and one of the top civil trial lawyers in America.
Our pharmaceutical liability team has a proven track record in holding pharmaceutical giants accountable for defective drugs. With years of experience and billions of dollars won in settlements and verdicts, we are committed to securing justice for those harmed by Oxbryta.
We are here to help you navigate the legal process and seek compensation for your suffering. Contact us today at 800-723-3216 to schedule a free consultation.
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