Table of Contents
Recently, the Oxbryta lawsuit is catching the attention of patients who took the medicine to treat their sickle cell anemia. Many plaintiffs claim that they suffered unexpected side effects that weren’t properly warned. In this blog, we’ll explore what led to the Oxbryta lawsuit, what it could mean for affected individuals, and why it’s a case worth watching closely.
What is Oxbryta?
Oxbryta, generically known as voxelotor, is a prescription medication developed by Global Blood Therapeutics (GBT). The drug is designed specifically for sickle cell disease patients aged 12 years and older.
Unlike traditional treatments that primarily focus on managing pain and preventing complications, Oxbryta operates differently. It targets hemoglobin directly, improving its ability to carry oxygen and reducing the clumping of red blood cells, which is common in sickle cell disease. This mechanism promises a more preventative approach to the disease by addressing the root cause of many symptoms.
Oxbryta was originally fast-tracked for approval by the FDA in 2019 for patients aged 12 and older, with approval extended to younger children in 2021. In 2022, Pfizer acquired Global Blood Therapeutics for $5.4 billion and sold the drug at about $88,000 per patient per year.
Understanding Sickle Cell Disease and Oxbryta’s Role
Sickle cell disease affects millions of people worldwide. It is a genetic blood disorder that affects how red blood cells work in the body. Normally, red blood cells are round and flexible, allowing them to flow smoothly through blood vessels.
In people with sickle cell disease, however, these cells become stiff, sticky, and shaped like “crescent moons,” or “sickles.” This abnormal shape makes it difficult for blood to flow properly, which can cause severe pain, fatigue, and other health issues, such as:
- Increased risk of infections
- Stroke
- Organ damage
- Anemia (due to fewer red blood cells)
Deaths Linked to Oxbryta
Since its approval in 2019, Oxbryta has been linked to 307 deaths reported to the FDA’s Adverse Event Reporting System (FAERS). These deaths, recorded annually, show an upward trend, peaking in 2024:
- 2020: 44 deaths
- 2021: 65 deaths
- 2022: 64 deaths
- 2023: 45 deaths
- 2024: 89 deaths
Plaintiffs allege that the companies either overlooked or withheld evidence of Oxbryta’s dangers to prioritize its market availability over patient safety.
Oxbryta Recall
On September 25, 2024, Pfizer announced it was pulling all Oxbryta (voxelotor) products from the market worldwide and stopping its ongoing clinical trials and access programs.
- HOPE Kids 2 Trial (GBT440-032) (NCT04218084)
The HOPE Kids 2 trial began in 2020, included 236 children aged 2 to 15 from Egypt, Kenya, Ghana, and the United States. The trial’s goal was to study Oxbryta’s effects on cerebral blood flow in children with sickle cell disease (SCD). Unfortunately, the trial saw alarming outcomes: eight children who were taking Oxbryta died, compared to only two deaths in the placebo group. Due to these high-risk outcomes, the study was stopped in September 2024, almost four months before its planned completion in January 2025.
- RESOLVE Trial (GBT440-042) (NCT05561140)
The RESOLVE trial, began in 2022, targeted patients aged 12 and older and was conducted in Brazil, Kenya, and Nigeria. This trial, which was open-label (meaning both researchers and participants knew they were receiving Oxbryta), aimed to examine the drug’s impact on leg ulcers in SCD patients. Unfortunately, eight deaths were reported in this study as well. Like HOPE Kids 2, the RESOLVE trial was also halted early in September 2024 because of mounting safety concerns after these fatalities.
- GBT440-038 Study (NCT04188509)
An additional study, GBT440-038, was an open-label extension trial that began in late 2019 to evaluate the long-term safety of Oxbryta for patients who completed earlier trials. This study was also shut down in September 2024, following the overall recall of Oxbryta due to safety risks and reports of severe adverse outcomes.
These findings suggest that the risks of Oxbryta outweigh its benefits for sickle cell patients. The data showed an increase in serious health issues, including painful episodes known as vaso-occlusive crises and some fatal events.
Vaso-occlusive crises (VOCs): One of the major concerns associated with Oxbryta is an increase in “vaso-occlusive crises.” It happens when misshapen, sickled red blood cells block blood flow in small blood vessels. This blockage restricts oxygen delivery to tissues, leading to intense pain and tissue damage. They can happen anywhere in the body but are commonly felt in the back, chest, arms, and legs.
Fatal events: There are some reports of fatal events in patients taking Oxbryta. While the exact connection between Oxbryta and these severe outcomes is still under investigation.
For those of you currently on Oxbryta or considering it, it’s essential to discuss these developments with your healthcare provider. They can guide you on next steps if you have been using a recalled Oxbryta or if you’re concerned about the risks. If you experience any side effects, report it to the FDA’s MedWatch program.
Oxbryta Lawsuit Update 2025
Many users reported serious complications, including pain, vaso-occlusive crises (VOC), strokes, and even death after taking Oxbryta. Since then, multiple lawsuits have been filed, including one by Tirrell Allen in November 2024.
On February 7, 2025, both sides in the Allen case submitted a joint case management statement outlining key issues. Judge Trian Thompson then issued a scheduling order on February 15, 2025.
Important deadlines include:
- Fact discovery: December 15, 2025
- Expert discovery: April 10, 2026
- Dispositive and Daubert motions: December 11, 2026
- Joint Statement on Related Cases: March 7, 2025
- Final pretrial conference: May 6, 2027
- Trial Date: June 7, 2027
Oxbryta Lawsuit Update 2024
On November 7, 2024, Tirrell Allen, an Illinois man filed a lawsuit against Global Blood Therapeutics Inc. and Pfizer Inc. He claims that the companies failed to warn about serious risks linked to Oxbryta, a drug for sickle cell disease (SCD), which led to him suffering a stroke and other severe complications.
Allen, who has lived with SCD since childhood, began taking Oxbryta in August 2024. Soon after, he experienced pain, swelling, and more frequent VOC episodes. In September, just before the recall, he suffered a stroke and remained hospitalized when he filed the lawsuit.
He alleges that Pfizer and Global Blood Therapeutics knew about these risks but did not properly inform patients or doctors. Allen’s lawsuit claims strict liability, design defects, negligence, failure to warn, and other violations, accusing the companies of prioritizing profits over patient safety.
December 2024 Update
On December 23, 2024, an Oxbryta class action lawsuit was filed against Pfizer. The lawsuit, brought by Rick Jolly, Amanda Winbush, Darryl Weekly, and Antonio Johnson, was seeking damages for anyone in the U.S. who paid out-of-pocket for Oxbryta since November 1, 2019.
The Oxbryta lawsuit claims Pfizer knew or should have known about these risks for years but failed to warn users. It also alleges that the company targeted underserved communities with misleading marketing.
October 2024 Update
In October 2024, Trebor Hardiman, an Illinois man, filed an Oxbryta lawsuit against Pfizer’s subsidiary, Global Blood Therapeutics, over side effects he experienced while taking the medicine. He was diagnosed with sickle cell anemia in childhood and started using Oxbryta in 2020.
Hardiman claims that the drug not only failed to reduce his painful sickle cell anemia, but it also led to a stroke, causing vision loss and affecting his ability to perform everyday activities. After being informed of the recall, he stopped taking Oxbryta but soon suffered complications related to the withdrawal and was hospitalized.
Hardiman’s lawsuit accuses Global Blood Therapeutics of inadequate testing and failing to warn about potential side effects. He also alleges negligence, design flaws, and misleading marketing practices.
The Oxbryta Lawsuit: Why Are People Suing?
As of now, many plaintiffs have started to file Oxbryta recall lawsuits. These lawsuits have been filed by patients and families who believe they were not sufficiently informed about certain side effects and potential health risks.
If you’re in a similar situation, seeking legal advice is one of the best options. Many law firms are currently taking Oxbryta-related cases. A lawyer’s guidance is advisable to get fair compensation.
To conclude,
While Oxbryta has offered hope for many, it’s not the only option. You can also try other alternatives like blood transfusions, Hydroxyurea and gene therapies. If you or a loved one is dealing with sickle cell anemia, it’s important to know about the treatment options, side effects, and any emerging news related to approved medications.
Stay informed for new updates on the Oxbryta lawsuit.
