Table of contents
- Latest Oxbryta Lawsuit Updates
- June 23, 2026: Release Reported in Pennsylvania Case
- December 9, 2025: European Commission Issues Final Decision
- October 17, 2025: EMA Confirms Oxbryta Suspension
- October 9, 2025: Settlement-in-Principle in Wrongful Death Case
- July 22, 2025: Defendants Move to Dismiss Wrongful Death Action
- May 14, 2025: Plaintiffs Oppose Motion to Dismiss
- April 23, 2025: Pfizer Moves to Dismiss Failure-to-Warn Suit
- September 26, 2024: FDA Alerts Patients and Providers
- September 25, 2024: Pfizer Withdraws Oxbryta Worldwide
- What Is Sickle Cell Disease?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Is There an Oxbryta Lawsuit?
- Has Pfizer Settled Any Oxbryta Lawsuits?
- What Did the Oxbryta Leg-Ulcer Trial Find?
- What Does the Research Say About Oxbryta?
Oxbryta (voxelotor) is a sickle cell disease drug that Pfizer withdrew worldwide in September 2024 over safety concerns. Lawsuits allege Pfizer and Global Blood Therapeutics failed to warn that it can cause deadly vaso-occlusive crises.
The FDA and the European Medicines Agency reported more deaths with Oxbryta than with placebo in some studies. Plaintiffs allege one patient died and a 13-year-old boy suffered several life-threatening vaso-occlusive crises.
The cases are individual federal suits plus one multi-plaintiff suit, and two have been reported settled. No MDL has been formed, and the defendants argue in court that federal law bars most of the claims.
Latest Oxbryta Lawsuit Updates
June 23, 2026: Release Reported in Pennsylvania Case
A status report filed before Judge Cathy Bissoon in Pennsylvania federal court said the plaintiffs had executed a release. It resolves a 13-year-old boy’s Oxbryta lawsuit with Pfizer and Global Blood Therapeutics [1].
The boy’s family alleges the drug caused several life-threatening vaso-occlusive crises. The terms of the release were not stated in the report.
December 9, 2025: European Commission Issues Final Decision
The European Commission issued its final legally binding decision on the EMA review of Oxbryta. The decision applies in all EU Member States [2].
That decision is the current status of the review, which followed the EMA’s human medicines committee, the CHMP, weighing the drug’s benefits and risks.
October 17, 2025: EMA Confirms Oxbryta Suspension
The EMA announcement said the CHMP recommended on October 16, 2025 that Oxbryta’s EU marketing authorisation stay suspended. It said the benefits no longer outweigh the risks [3].
The committee had first recommended suspending the drug on September 26, 2024, as a precaution, one day after Pfizer withdrew the drug worldwide.
October 9, 2025: Settlement-in-Principle in Wrongful Death Case
Pfizer and Global Blood Therapeutics told Judge Trina Thompson in California federal court they had reached a settlement-in-principle. The deal is with a Tennessee woman who alleges Oxbryta caused her husband’s death [4].
They asked for 60 days to finalize the settlement, after which the plaintiff would file a dismissal notice. The settlement terms were not stated in the notice.
July 22, 2025: Defendants Move to Dismiss Wrongful Death Action
Pfizer and Global Blood Therapeutics asked the same California court to dismiss the Tennessee woman’s wrongful death action over her husband’s Oxbryta use [5].
They argued that federal law bars most claims and that the fraud-based claims fail the heightened pleading requirements of Rule 9(b). These points are arguments by the defendants.
May 14, 2025: Plaintiffs Oppose Motion to Dismiss
Plaintiffs in the multi-plaintiff Oxbryta failure-to-warn lawsuit opposed Pfizer’s motion to dismiss in the same California court, answering the motion filed on April 23, 2025 [6].
They said the defendants have not proved by clear evidence that the FDA would have rejected stronger warnings. That is the plaintiffs’ argument.
April 23, 2025: Pfizer Moves to Dismiss Failure-to-Warn Suit
Pfizer and Global Blood Therapeutics moved to dismiss a multi-plaintiff lawsuit before Judge Trina Thompson in the same court [7].
The suit accuses them of failing to warn that Oxbryta can cause deadly vaso-occlusive crises. It is a multi-plaintiff suit and not a class action. The motion argued that most claims are preempted by federal law.
September 26, 2024: FDA Alerts Patients and Providers
The FDA alerted patients and health care professionals that Oxbryta was being voluntarily withdrawn for safety concerns. The alert followed Pfizer’s announcement the day before [8].
The FDA told health care professionals to stop prescribing Oxbryta. Its safety review was continuing, and it said it would share any additional findings when the review ends.
September 25, 2024: Pfizer Withdraws Oxbryta Worldwide
Pfizer announced in a press release that it was voluntarily withdrawing all lots of Oxbryta (voxelotor) in all markets where it is approved [9].
Pfizer also ended all active voxelotor clinical trials and expanded access programs. It described Oxbryta as an oral, once-daily therapy for patients with sickle cell disease. Global Blood Therapeutics is a Pfizer subsidiary.
What Is Sickle Cell Disease?
According to the CDC, sickle cell disease is a group of inherited red blood cell disorders. The hemoglobin is abnormal, so red blood cells become hard and sticky and look like a sickle [10].
Those cells can get stuck in small blood vessels and cause pain and other serious complications. Oxbryta was prescribed to people with this condition, and the lawsuits concern patients who then had crises or died.
Who May Be Affected?
People with sickle cell disease who were prescribed Oxbryta between its 2019 U.S. accelerated approval and its September 2024 withdrawal may be affected. That includes adults and children as young as 4.
The FDA approved Oxbryta for ages 12 and older in 2019 and for ages 4 to 11 in 2021, under its accelerated approval pathway.
Some patients then had vaso-occlusive crises, and some families lost a loved one after Oxbryta use. Only an individual legal review can say whether a situation qualifies.
Reported Injuries or Damages
The lawsuits allege that Oxbryta caused the death of a Tennessee man and several life-threatening vaso-occlusive crises in a 13-year-old boy. These are allegations and have not been proved.
The FDA said Pfizer reported a higher rate of vaso-occlusive crisis with Oxbryta than with placebo in postmarketing clinical trials. The FDA also reported more deaths in the Oxbryta group and a higher crisis rate in two real-world registry studies.
The EMA said a trial in people at higher risk of stroke recorded 8 deaths among children given Oxbryta and 2 on placebo. MedPage Today reported that this trial enrolled 236 patients [11].
A leg-ulcer trial recorded 1 death in the Oxbryta group in the first 12 weeks, against none on placebo. The CDC lists pain, infection, acute chest syndrome and stroke as complications of sickle cell disease itself.
Recall and Regulatory Background
Pfizer said the benefit of Oxbryta “no longer outweighs the risk.” Its data “suggest an imbalance in vaso-occlusive crises and fatal events.”
Patients and caregivers should contact their health care professional about stopping Oxbryta and starting another treatment. Pfizer Medical Information is at 1-800-438-1985. Adverse events can be reported through the FDA adverse event reporting program at www.fda.gov/medwatch/report.htm.
Evidence to Preserve
Keep these records, because they can show what was taken, when, and what followed:
- Prescription and pharmacy records that show each Oxbryta refill, the dose and the date.
- Bottle labels or lot numbers, if you still have the packaging from any Oxbryta fill.
- Medical records of crises, emergency visits and hospital stays before and after starting Oxbryta.
- Scans and lab results, and for a death, the death certificate and any autopsy report.
- Messages with the doctor, the pharmacy and the insurer, including any notice of the withdrawal.
- Billing and insurance records, plus a personal log of symptoms and the dates they happened.
Filing Deadlines
Filing deadlines for injury and wrongful-death claims come from state law, so the time limit depends on where you live.
The deadline can also depend on when the injury, the death or the diagnosis happened. Some states start the clock when the harm is discovered.
If a deadline passes, an Oxbryta claim can end even when the medical records are strong. Talk with a lawyer soon.
Frequently Asked Questions
Is There an Oxbryta Lawsuit?
There is an Oxbryta lawsuit. Plaintiffs have brought one multi-plaintiff failure-to-warn suit in California. Other patients and families have filed individual federal suits against Pfizer and Global Blood Therapeutics, including a case in Pennsylvania.
Has Pfizer Settled Any Oxbryta Lawsuits?
Two Oxbryta lawsuits against Pfizer have been reported settled, one in California and one in Pennsylvania. The reports do not state the terms or amounts, so no Oxbryta settlement figure is public.
What Did the Oxbryta Leg-Ulcer Trial Find?
The Oxbryta leg-ulcer trial enrolled 88 patients, according to MedPage Today, with 8 deaths in the next 12 weeks, when all patients received Oxbryta. This trial is separate from the stroke-risk trial.
What Does the Research Say About Oxbryta?
The research on Oxbryta points to more deaths and crises than placebo in some studies. The EMA committee found no clear explanation for the increased risks, and the final registry analysis did not confirm an increase in sudden pain episodes.