Oxbryta Lawsuit
Legally Reviewed By: Rebecca Phillips
Mass Torts Director
Co-Lead Plaintiffs Counsel – Bard PowerPort Multi-District Litigation
- Page Last Updated:
- November 22, 2024
Legally Reviewed By: Rebecca Phillips
Mass Torts Director
Co-Lead Plaintiffs Counsel –
Bard PowerPort Multi-District Litigation
- Page Last Updated:
- November 22, 2024
Pfizer Inc. recently announced a voluntary recall of its sickle cell disease treatment medication, Oxbryta, after post-market trials and studies linked the drug to a higher frequency of serious side effects and deaths among patients.
Voxelotor, which Pfizer sells under the brand name Oxbryta, is used to treat sickle cell disease.
While the FDA granted accelerated approval of the drug in 2019, it now appears that the drug does more harm than good. Based on recent trial data, Pfizer now believes “the benefit of Oxbryta does not outweigh the risk.”
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 for a free consultation.
Oxbryta Lawsuits: A Timeline
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?
Global Blood Therapeutics Inc. developed Oxbryta to treat the effects of sickle cell disease, a hereditary blood disorder affecting more than 20 million people worldwide. Pharmaceutical Pfizer purchased Global Blood in 2022 for $5.4 billion.
The FDA granted accelerated approval to Oxbryta in November 2019, citing 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.
Why Is Oxbryta Being Recalled?
Initially reported side effects listed for Oxbryta included headaches, nausea, fatigue, abdominal pain, drug hypersensitivity, diarrhea, rashes, and fevers.
However, later studies linked Oxbryta 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.
In light of the recall, harmful side effects from taking Oxbryta have already prompted at least one lawsuit against Pfizer and Global Blood Therapeutics.
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
Our skilled pharmaceutical liability team is dedicated to advocating for those harmed by defective drugs and holding manufacturers accountable. We have extensive experience taking on pharmaceutical giants like Pfizer and achieving significant results, winning billions of dollars for our clients in verdicts and settlements. Our firm has the skill, knowledge, and expertise to handle your Oxbryta lawsuit and secure you the compensation you deserve.
Call us today at 800-723-3216 to schedule a free consultation.
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