Oxbryta has been linked to an increased risk of stroke. The drug, which was developed to treat sickle cell disease (SCD), has been pulled from the market after mounting evidence linked it to an increased risk of stroke, vaso-occlusive crises, and death. On September 25, 2024, Pfizer voluntarily withdrew all lots of Oxbryta globally. The next day, the U.S. Food and Drug Administration (FDA) issued a public alert, confirming the recall and urging healthcare professionals to stop prescribing the drug.
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If you or a loved one suffered a stroke while taking Oxbryta, you may have grounds to file a lawsuit to recover compensation. Ankin Law is actively investigating cases involving Oxbryta injuries for victims nationwide. Call us at 312-600-0000.
Oxbryta Recalled Over Stroke Risk
Pfizer’s decision to voluntarily recall Oxbryta followed a review of postmarketing data that showed disturbing safety signals. Patients taking Oxbryta were experiencing more frequent and more severe complications of sickle cell disease — the very issues the drug was meant to treat. In particular, regulators noted a heightened risk of ischemic stroke and vaso-occlusive crises, both of which can be fatal.
The recall is a major reversal for a drug that was once described as a breakthrough in SCD treatment. Approved by the FDA in 2019 under the agency’s accelerated approval program, Oxbryta was intended to increase hemoglobin levels by inhibiting hemoglobin polymerization, a key factor in sickle cell complications. But the longer-term data revealed a different story.
What the FDA and Pfizer Are Saying
According to the FDA’s September 26, 2024 alert, patients who are currently taking Oxbryta should stop using the drug and contact their healthcare providers to discuss alternative treatments. The agency emphasized that the voluntary withdrawal is not due to manufacturing issues, but rather serious concerns about the drug’s safety profile.
Pfizer echoed these concerns in its official press release, stating: “We believe the totality of the postmarketing data now available presents a different benefit-risk profile than was understood at the time of approval.” The company is cooperating with global regulatory bodies and has ceased distribution of Oxbryta worldwide. Their actions, however, are too little too late.
How Did Oxbryta Get Approved in the First Place?
Oxbryta was approved through the FDA’s accelerated approval pathway, which is designed to get promising drugs to patients faster. However, the program has come under scrutiny in recent years after multiple fast-tracked drugs were later found to pose serious risks.
In the case of Oxbryta, the approval was based primarily on biomarkers — specifically, increases in hemoglobin — rather than long-term clinical outcomes. The assumption was that higher hemoglobin levels would translate to fewer sickle cell complications. That assumption didn’t hold up under real-world conditions.
Reported Side Effects and Adverse Events
Patients and caregivers began reporting troubling Oxbryta side effects shortly after the drug hit the market. These included:
- Ischemic stroke
- Vaso-occlusive crises (painful blockages of blood vessels)
- Fatigue
- Headache
- Diarrhea
- Rash
- Liver enzyme abnormalities
However, it was the increase in life-threatening complications — particularly vaso-occlusive crises and strokes — that ultimately triggered the drug’s withdrawal.
Understanding the Link Between Oxbryta and Stroke
The exact mechanism by which Oxbryta may increase stroke risk is not fully understood, but several hypotheses are under consideration:
Altered Blood Flow and Hemoglobin Binding
Oxbryta increases hemoglobin’s ability to bind with oxygen, which can improve oxygen delivery but may also affect blood viscosity and flow. In children with SCD—who are already at risk for vascular blockages—any changes in blood properties can potentially trigger clotting or cerebral ischemia.
Subclinical Strokes in Children
Some of the strokes identified in the study were “silent,” meaning they didn’t cause immediate symptoms but showed up as abnormalities on MRIs. Silent strokes can lead to long-term cognitive issues, developmental delays, and increased risk of future strokes.
Age-Specific Risks
While the trial focused on pediatric patients, these findings may have implications for adult patients as well. The risk profile for a 30-year-old with sickle cell disease is not identical to that of a 5-year-old—but if the underlying drug mechanism is the problem, then no age group is automatically safe.
What Pfizer Knew—and When
Global Blood Therapeutics, which developed Oxbryta, was acquired by Pfizer in 2022. By that point, Oxbryta was already on the market and being widely promoted as a treatment for children and adults with sickle cell disease.
The FDA’s approval of Oxbryta was based on earlier trials that showed improvement in hemoglobin levels but didn’t focus heavily on long-term neurological risks. The safety concerns only emerged in a post-market trial required as part of the approval process.
That raises a serious question: Why wasn’t this risk caught earlier?
Drugmakers have a duty to conduct comprehensive testing and post-market surveillance. If Pfizer or its predecessor failed to detect—or worse, ignored—evidence of increased stroke risk, that could amount to negligence.
The Human Cost of Pharmaceutical Negligence
Sickle cell patients already face a lifetime of medical hurdles. Families have to navigate ER visits, specialist care, missed school days, and expensive medications. When a drug designed to help these patients ends up causing further injury, the betrayal is deep.
Children who suffer strokes may face lifelong complications:
- Learning disabilities
- Difficulty with speech and motor control
- Emotional and behavioral challenges
- Need for assistive devices or special education
Adults who suffer strokes may lose their ability to work, drive, or care for themselves. In both cases, the emotional and financial toll is immense.
Legal Action and Your Rights
Patients who suffer serious side effects from a recalled drug may be entitled to compensation for their injuries. Pharmaceutical companies have a legal duty to ensure that their products are safe and that any risks are properly disclosed. If they fail in that duty, they can be held liable through product liability lawsuits.
In the case of Oxbryta, potential claims could involve:
- Failure to warn of known or foreseeable risks
- Defective drug design or testing
- Negligence in monitoring postmarketing safety data
If you or a family member suffered a stroke or other complications after taking Oxbryta, you may be eligible to file a claim for damages. You may be entitled to compensation for:
- Medical bills
- Long-term care and therapy
- Pain and suffering
- Lost wages or reduced future earning potential
- Emotional distress
- Wrongful death, in fatal cases
Oxbryta Lawsuits: What to Expect
Oxbryta lawsuits may ultimately be consolidated into a mass tort or multidistrict litigation (MDL), depending on the number of injuries reported. That process can streamline discovery and litigation, but still allows each victim’s case to be evaluated individually.
The first Oxbryta lawsuit to go to trial is scheduled for June 2027. Some Oxbryta settlements may come sooner, however. The outcome of the first trials will likely significantly impact Oxbryta settlement amounts in the future. Cases with aggressive legal teams, strong evidence, and the most severe injuries usually settle for larger amounts.
Evidence That May Support Your Claim
To build a strong case, your attorney will look for:
- Medical records confirming stroke diagnosis and treatment
- Prescription records showing Oxbryta use
- Imaging results (such as MRI or CT scans)
- Neurologist reports
- Expert testimony linking the drug to your condition
What Should Patients Do Now?
If you or your child is currently taking Oxbryta, do not stop taking it without consulting your healthcare provider. Suddenly discontinuing the drug could trigger a sickle cell crisis or other complications.
That said, if you’ve already experienced a stroke or neurological symptoms while on Oxbryta, contact our attorneys right away.
Ankin Law Is Investigating Oxbryta Stroke Claims
We are actively reviewing cases involving:
- Pediatric or adult stroke while taking Oxbryta
- MRI evidence of silent strokes
- Worsening neurological symptoms
- Long-term disability linked to Oxbryta use
Our attorneys will examine your medical history, treatment records, and expert assessments to determine whether you have a viable case. We’ll deal with the pharmaceutical company and their lawyers—so you don’t have to.
Oxbryta Stroke Victims Deserve Justice
When you take a drug that’s supposed to manage a serious disease, you have every right to expect that it won’t make things worse. The FDA’s findings about Oxbryta raise red flags that no patient can afford to ignore. The link between Oxbryta and stroke—especially in children—is not just a minor medical issue. It could be a deadly one.
At Ankin Law, we fight for those who’ve been harmed by corporate carelessness and rushed drug approvals. If you or someone you love has been affected, call us. We’re ready to stand up for you.
Contact Ankin Law
Call Ankin Law at 312-600-0000 or contact us online for a free consultation. We’re based in Chicago and represent clients nationwide in dangerous drug cases, including those involving recalled medications like Oxbryta. We handle pharmaceutical injury cases on a contingency fee basis. That means you don’t pay unless we recover compensation for you.
