Oxbryta Recall Lawsuits Claim Drug Manufacturer Knew About Fatality Risks for Years

Following a recent Oxbryta recall, which removed the sickle cell disease drug from the market amid an alarming number of vascular injuries during clinical trials, there is now growing evidence that suggests the drug manufacturer was aware of hundreds of Oxbryta fatalities reported in recent years, yet failed to take steps to warn users or the medical community.

Oxbryta (voxelotor) was first introduced in 2019 by Global Blood Therapeutics, which was later acquired by Pfizer for $5.4 billion in 2022. It was the first oral medication specifically approved to treat sickle cell disease, which is a lifelong blood disorder that affects protein in the blood, causing blood cells to break down and die due to a lack of oxygen.

The Oxbryta tablets were quickly adopted by patients across the nation, as a convenient alternative to existing sickle cell disease treatments, which were largely limited to intravenous drugs, blood transfusions or bone marrow transplants.

Within a year of gaining accelerated approval from the U.S. Food and Drug Administration (FDA), a number of adverse event reports began to emerge linking Oxbryta to serious side effects, including painful vascular injuries, strokes and fatalities.

Although these risks have been reported since 2020, the drug maker only recently issued a global recall of Oxbryta in September 2024, citing new clinical trial data that revealed a heightened incidence of vaso-occlusive crises (VOC) and fatal events among patients using the medication.

As a result of the drug maker’s failure to previously disclose these risks, a number of former users are now investigating Oxbryta recall lawsuits against Global Blood Therapeutics, alleging that the company not only failed to thoroughly research the efficacy of the sickle cell disease drug, but also ignored evidence of vascular injuries and fatality rates for years.

Oxbryta Clinical Trial Deaths Led to Recall

Reports have suggested that Pfizer’s decision to recall and withdraw Oxbryta from the market was based on the totality of clinical trial data, which identified a total of 16 Oxbryta patient deaths across two Phase III trials.

In the HOPE Kids 2 trial (GBT440-032), which began in 2020 and was set to conclude in January 2025, eight patients on Oxbryta died, compared to two in the placebo group. This study included 236 children between the ages of 2 and 15, from countries such as Egypt, Ghana, Kenya and the United States.  The research focused on assessing Oxbryta’s effects on cerebral blood flow in children with sickle cell disease (SCD), who were at high risk of stroke. However, the trial was terminated early in September 2024, due to concerns over patient safety.

In the RESOLVE trial (GBT440-042), which started in 2022 and involved 88 patients aged 12 and older from Brazil, Kenya and Nigeria, there were at least eight deaths reported in the open-label portion, which evaluated Oxbryta’s impact on leg ulcers. Like HOPE Kids 2, this trial also ended prematurely in September 2024, following the Oxbryta recall.

Additionally, the GBT440-038 study (NCT04188509) was an open-label extension trial launched in late 2019, which was designed to evaluate the long-term safety of Oxbryta in patients who had completed earlier trials. However, this study was also halted in September 2024, after the drug was removed from the market.

Hundreds of Oxbryta Fatalities Reported to FDA Since 2020

While Pfizer’s decision to withdraw Oxbryta from the market is widely considered appropriate, concerns have emerged that the company may have been aware of reports detailing hundreds of fatalities on Oxbryta since 2020, but ignored those safety signals, placing patients at risk.

According to the FDA’s Adverse Event Reporting System (FAERS), a total of 307 deaths have been linked to Oxbryta since the drug became available on the market in 2019, with the total number of reported Oxbryta fatalities remaining significant each year since the drug was introduced:

• 2020: 44 Oxbryta deaths
• 2021: 65 Oxbryta deaths
• 2022: 64 Oxbryta deaths
• 2023: 45 Oxbryta deaths
• 2024: 89 Oxbryta deaths

Critics now suggest that these mounting fatalities reported by Oxbryta users highlight significant problems with the drug maker’s monitoring and communication about the potential risks.

November 2024 Oxbryta Recall Lawsuit Update

Following the recall of Pfizer’s sickle cell disease drug, the first Oxbryta lawsuits are now being filed, alleging that Global Blood Therapeutics knew or should have known about the risk of vaso-occlusive crises (VOCs), stroke and other side effects, yet failed to warn the medical community.

Plaintiffs claim that Global Blood Therapeutics, and later Pfizer, prioritized keeping Oxbryta on the market, over patient safety.  As a result, thousands of users may have experienced severe and life-threatening complications from Oxbryta, which may have been avoided if they had received a different treatment for sickle cell disease.

Lawyers are providing free consultations and claim evaluations to help former users determine if they may be eligible for financial compensation through an Oxbryta lawsuit settlement for side effects, injuries, or severe complications that may have been caused by the medication, including:

• Vaso-occlusive crises (VOCs)
• Stroke
• Severe pain and swelling
• Death