Oxbryta Lawsuit | Get the Right Lawyer

What is Oxbryta?

Manufactured and marketed by Pfizer Inc., Oxbryta (generic: voxelotor) is prescribed for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older [1.]. The drug works by preventing hemoglobin from forming chains, which is the process that causes red blood cells to deform and become sickle-shaped, and improving anemia by increasing the amount of hemoglobin in the blood. Oxbryta was first approved by the U.S. Food and Drug Administration (FDA) in 2019.

Oxbryta Recall

On September 26, 2024, the FDA issued a warning to patients, caregivers and healthcare providers stating that Oxbryta was being voluntarily withdrawn from the market after postmarketing clinical trials and 2 real-world registry studies identified a higher rate of death and vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease who took the medication [2.].

“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. Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw OXBRYTA from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.”

FDA is urging healthcare professionals to stop prescribing Oxbryta, and for patients and caregivers to contact their physician about discontinuing Oxbryta in favor of a sickle cell treatment with a more favorable risk profile.

Oxbryta Side Effects

Serious side effects of Oxbryta may include:

• Vaso-occlusive crisis
• Severe allergic reactions
• Death

Other, less severe side effects of Oxbryta may include:

• Headache
• Diarrhea
• Stomach-area (abdominal) pain
• Nausea
• Rash or hives
• Fever

Understanding Vaso-Occlusive Crisis (VOC)

A vaso-occlusive crisis (VOC) occurs when sickle-shaped red blood cells obstruct blood flow, leading to oxygen deprivation in tissues, according to Sickle Cell Disease News [3.]. This triggers an inflammatory response as the body attempts to resolve the blockage, resulting in intense pain. VOC can affect various parts of the body but most commonly impacts the back, chest, and limbs.

The 4 Phases of a Vaso-Occlusive Crisis

• Phase 1: Lasting around three days, this phase involves low-intensity, aching pain, sometimes accompanied by tingling or numbness as tissues begin to experience oxygen deprivation.
• Phase 2: Pain intensity quickly escalates as the affected tissue starts to die, leading to acute discomfort.
• Phase 3: Characterized by the body’s inflammatory response to tissue death, severe and constant pain occurs, often accompanied by fever, lasting several days.
• Phase 4: The crisis resolution phase, typically lasting one to two days, where the pain gradually subsides.

“VOC is the most common cause of hospitalization related to SCD. In addition to causing acute pain, these crises can set the stage for further health complications, such as arthritis, kidney failure, and strokes.”

Recognizing Symptoms of a Vaso-Occlusive Crisis

According to WebMD, the most common symptom of a vaso-occlusive crisis (VOC) is sudden pain, which can feel dull, stabbing, throbbing, or sharp [4.]. The severity and duration of the pain may vary from person to person, and while some individuals experience crises occasionally, others may face them monthly.

Common Pain Locations

Pain can occur anywhere in the body and may affect multiple areas simultaneously, but it often concentrates in:

• Arms and legs
• Abdomen
• Chest
• Hands and feet (especially in young children)
• Lower back

Additional Symptoms

Alongside pain, you might experience:

• Difficulty breathing or pain when breathing
• Severe fatigue
• Headaches or dizziness
• Painful erections in males (priapism)
• Muscle weakness or difficulty moving certain body parts
• Yellowing of the skin or eyes (jaundice)

Key Statistics About Sickle Cell Disease (SCD)

• SCD Prevalence in the United States – The estimated number of people living with SCD in the U.S. ranges between 70,000 to 100,000.
• Impact by Race – Over 90% of individuals with SCD in the U.S. are non-Hispanic Black or African American, while around 3–9% are Hispanic or Latino.
• Birth Prevalence – SCD affects approximately 1 in 365 Black or African American newborns and about 1 in 16,300 Hispanic American births.
• Sickle Cell Trait (SCT) – About 1 in 13 Black or African American infants are born with sickle cell trait (SCT), inheriting one sickle cell gene from a parent.
• Life Expectancy – The average life expectancy for individuals with SCD who have public insurance is 52.6 years, with males typically having a shorter lifespan than females.
• Global Prevalence – Worldwide, more than 100 million people carry the sickle cell trait.
• Hemoglobin Disorders – Approximately 5% of the global population carries genetic traits for hemoglobin disorders, such as SCD and thalassemia.

Source: U.S. Centers for Disease Control and Prevention (CDC) [5.]

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Get a Free Oxbryta Lawsuit Evaluation With Our Lawyers

The Dangerous Drugs Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Oxbryta Lawsuits. We are handling individual litigation nationwide and are currently accepting new cases in all 50 states.

Again, if you or a loved one have been injured by Oxbryta side effects, you should contact an Oxbryta Lawyer immediately for a free case review. You may be entitled to a settlement by filing a suit and our lawyers can help.

References:
1. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntarily-withdraws-all-lots-sickle-cell-disease
2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerting-patients-and-health-care-professionals-about-voluntary-withdrawal-oxbryta-market-due#:~:text=%5B9%2F26%2F2024%5D,professionals%20should%20stop%20prescribing%20Oxbryta
3. https://sicklecellanemianews.com/vaso-occlusive-crisis/
4. https://www.webmd.com/a-to-z-guides/sickle-cell-crisis
5. https://www.cdc.gov/sickle-cell/data/index.html