Oxbryta Lawsuit Overview

Oxbryta (voxelotor) is a prescription drug that was introduced in 2019, for treatment of sickle cell anemia in children or adults. Although it was promoted as safe and effective, it soon became clear that the risk of Oxbryta side effects outweighs any potential benefits provided by the medication.

In September 2024, Pfizer issued an Oxbryta recall, amid growing medical evidence and adverse event reports linking the drug to an increased risk of vaso-occlusive crises (VOCs) and patient deaths.

As a result of the drug makers’ failure to adequately warn about these risks, the product liability lawyers at Saiontz & Kirk, P.A. are now investigating Oxbryta lawsuits for sickle cell patients who experienced problems while using the medication.

Oxbryta lawsuits allege that Pfizer and Global Blood Therapeutics failed to thoroughly investigate the drug’s safety profile, and either knew or should have known about the serious risks of VOCs and other side effects associated with Oxbryta.

Oxbryta Label Failed to Warn About Side Effects

Oxbryta (voxelotor) is a prescription medication designed by Global Blood Therapeutics, Inc. to treat sickle cell anemia, which is a genetic blood disorder that causes red blood cells to form a sickle shape, obstructing blood flow and resulting in intense pain and potential organ damage.

The U.S. Food and Drug Administration (FDA) granted Oxbryta accelerated approval based on promising phase-3 trial data, which suggested that Oxbryta increased hemoglobin levels and reduced hemolysis, potentially addressing key symptoms of SCD. In December 2021, the FDA extended Oxbryta’s approval to treat sickle cell disease in children as young as four years old.

The Oxbryta warning label indicates common side effects may include headache, diarrhea, abdominal pain, nausea, rash or hives, and fever. However, children aged 4 to 11 also commonly experienced vomiting, abdominal pain, diarrhea, and headaches.

However, it does not appear the manufacturer provided adequate warnings about the risks of vaso-occlusive crises (VOCs), stroke, organ failure, or other severe side effects from Oxbryta.

Pfizer Recalls Oxbryta Sickle Cell Drug

After only several years on the market, Pfizer announced an Oxbryta recall on September 25, 2024, after emerging data revealed an increased occurrence of vaso-occlusive crises and fatal events among patients taking the medication, stating:

“Pfizer’s decision is based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population. The data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment.”

FDA Issues Oxbryta Warning

According to an Oxbryta market removal notice released by the FDA, post-marketing clinical trials revealed that patients treated with Oxbryta for sickle cell disease experienced a higher incidence of vaso-occlusive crises compared to those on a placebo.

The agency also noted that it has been tracking Oxbryta side effects from real-world registry studies and post-marketing adverse events through the FDA Adverse Event Reporting System (FAERS), which confirmed a higher death rate among patients in the Oxbryta treatment group compared to the placebo group.

European Medicines Agency Recommends Oxbryta Market Removal

On September 26, 2024, the European Medicines Agency (EMA) issued an Oxbryta suspension recommendation, citing new evidence that links Oxbryta to higher rates of vaso-occlusive crises (VOC) and death, when compared to individuals taking alternative drugs for sickle cell disease treatment. The EMA highlighted the gravity of these findings, stating:

“Overall, these data raise serious concerns about the safety of Oxbryta; due to the increased uncertainties, it therefore recommended that the authorization, marketing, and supply of the medicine be suspended until all the available data have been assessed in the ongoing review.”

The EMA warned that vaso-occlusive crises are among the most common complications of sickle cell disease, and involve episodes of acute pain and can lead to further health complications, such as arthritis, kidney failure and stroke.

Studies Link Oxbryta to Vaso-Occlusive Crises (VOCs) and Fatalities

Data from multiple clinical trials have linked Oxbryta to a heightened risk of severe vaso-occlusive crises (VOCs), fatalities, and other serious health complications across all age groups of sickle cell disease patients.

HOPE Kids 2 Study Reveals Increased Pediatric Mortality

The HOPE Kids 2 study significantly altered the safety perspective on Oxbryta, revealing a troubling rate of fatalities among young sickle cell patients.

In this randomized, placebo-controlled trial involving children ages 2 to 15, eight children taking Oxbryta died compared to only two deaths in the placebo group.

Originally planned to conclude in January 2025, the study was suspended early due to these alarming results, which likely influenced Pfizer’s decision to withdraw the drug from the market.

RESOLVE Study Reveals Additional Safety Concerns for Oxbryta

Alongside the findings from HOPE Kids 2, the RESOLVE study highlighted further safety concerns for Oxbryta, particularly among older sickle cell disease patients.

This phase-3 clinical trial aimed to evaluate Oxbryta’s effectiveness in treating leg ulcers in sickle cell disease patients aged 12 and older. However, rather than demonstrating clear therapeutic benefits, eight of the 88 patients taking Oxbryta died.

The unexpected fatalities within the RESOLVE study suggest that the risks linked to voxelotor may not be limited to pediatric patients, but could extend to older age groups as well.

Lawsuits Over Oxbryta Side Effects

Oxbryta side effect lawsuits are now being filed against the manufacturers, alleging that the companies were aware of the risks of vaso-occlusive crises (VOCs) and death, yet failed to provide adequate warnings to patients and healthcare providers.

Oxbryta Vaso-Occlusive Crisis (VOC) Lawsuit

Vaso-occlusive crisis (VOC) is a serious complication in sickle cell disease, occurring when rigid, crescent-shaped red blood cells block blood flow in small vessels, contrasting with the smooth flow allowed by round, flexible normal red blood cells. This obstruction disrupts blood circulation and oxygen supply, leading to intense pain and potentially causing tissue and organ damage.

For sickle cell patients, VOCs are the primary reason for emergency hospital admissions due to the severe pain and health risks they pose.

Oxbryta was promoted to manage sickle cell disease by enhancing hemoglobin’s oxygen-carrying capacity to reduce cell sickling. However, lawsuits allege that Oxbryta may not have prevented VOCs and, in some cases, may have worsened them, leading to an increased risk of fatal events without sufficient warnings for users.

Common Symptoms of VOCs Linked to Oxbryta:

• Severe, sharp pain in the chest, abdomen, limbs, or joints
• Swelling, particularly in the hands and feet
• Fever due to inflammation from blocked circulation
• Fatigue as the body struggles to manage the crisis
• Pale skin or jaundice, indicating high red blood cell breakdown
• Shortness of breath and risk of acute chest syndrome

Oxbryta Stroke Lawsuit

In patients with sickle cell disease, strokes are a known risk due to VOCs blocking small blood vessels in the brain.

Lawsuits claim that Oxbryta failed to prevent strokes and may have heightened stroke risk by exacerbating VOC occurrences.

Symptoms of Stroke Potentially Linked to Oxbryta:

• Sudden numbness or weakness, particularly on one side
• Confusion, speech difficulties, or trouble understanding
• Visual disturbances in one or both eyes
• Dizziness, coordination issues, or balance loss
• Severe, unexplained headache
• Altered consciousness or sudden unresponsiveness

Oxbryta Painful Swelling Lawsuit

Pain and swelling are core symptoms of sickle cell disease exacerbated by VOCs, as blocked blood vessels lead to tissue damage and inflammation.

Lawsuits claim that Oxbryta failed to alleviate these issues, and may have worsened pain and swelling due to increased VOC frequency or other adverse vascular impacts.

Common Pain and Swelling Symptoms Associated with Oxbryta:

• Intense, sharp pain in bones, joints, and soft tissues
• Swelling in limbs or joints, often warm or tender to the touch
• Redness and increased warmth in swollen areas
• Limited mobility due to pain and inflammation
• Long-lasting painful episodes, sometimes persisting for hours or days

Oxbryta Organ Failure Lawsuit

Patients using Oxbryta for sickle cell disease (SCD) may be at heightened risk of organ failure, a serious complication often associated with vaso-occlusive crises (VOCs) and compromised blood flow. Organ failure can occur when sickled red blood cells obstruct circulation to critical organs, depriving them of oxygen and nutrients.

Lawsuits allege that Oxbryta’s manufacturer failed to adequately warn of these serious health risks, which may have been exacerbated by the drug’s effects on vascular health.

Organs Most at Risk

• Kidneys: Blocked blood flow may damage kidney tissue, leading to kidney failure, which is common among SCD patients and can require dialysis or even organ transplantation.
• Liver: Reduced oxygen supply and excessive red blood cell breakdown can lead to liver failure, jaundice, and other severe liver conditions.
• Heart: Heart failure or cardiac complications may arise from prolonged oxygen deprivation and increased stress on the cardiovascular system.
• Lungs: Lung tissue damage and acute chest syndrome, a serious lung-related complication of SCD, may worsen with Oxbryta use, contributing to respiratory failure.

Oxbryta Lawsuit Settlements

Individuals who have suffered injuries from Oxbryta side effects may be entitled to compensation for the following damages:

• Medical Expenses: Covers the cost of treatments, hospital stays, and ongoing medical care resulting from Oxbryta side effects.
• Pain and Suffering: Compensation for the physical pain and emotional distress caused by severe side effects or complications.
• Lost Wages: Reimbursement for income lost due to time missed from work while recovering from Oxbryta-related health issues.
• Loss of Future Earnings: Compensation if injuries or complications limit the individual’s ability to work in the future.
• Wrongful Death: For families who lost a loved one due to Oxbryta complications, this includes compensation for the loss of life and related expenses.
• Funeral and Burial Costs: Covers expenses for funeral and burial services in cases of death resulting from Oxbryta.
• Loss of Consortium: Compensation for the impact on relationships and family life due to injuries or death caused by the drug.

Are there any costs to hire an Oxbryta lawyer?

There are absolutely no out-of-pocket costs to hire our attorneys or speak with us about your potential case. All Oxbryta lawsuits are handled on a contingency fee basis.

Through the use of contingency fees, individuals have access to the resources of our experienced mass tort litigation firm for their potential Oxbryta lawsuit — regardless of their individual financial resources.

You pay nothing up front to hire our Oxbryta lawyers, and we only receive an attorney fee or expenses out of the money that is obtained from the manufacturer. Our law firm receives nothing unless we win your case!