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Pfizer has voluntarily withdrawn Oxbryta (voxelotor), a treatment for sickle cell disease (SCD), from the market following serious safety concerns. The withdrawal means stopping distribution of the drug and discontinuing all active clinical trials. The recall results from recent findings that the risks of the medication outweigh its benefits.
Our lawyers are investigating cases where patients suffered Oxbryta vaso-occlusive crises and injuries occurring resulting from vaso-occusive crises, including death.
We have helped obtain over $80 billion for victims of drug injuries, defective products, and other outcomes of corporate negligence, and we stand ready to help you with your claim. Call us at (800) 277-1193 or fill out our brief Free Evaluation Form.
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People who file Oxbryta lawsuits might seek compensation for Oxbryta side effects and injuries.
The amount of a jury award or settlement you could receive in an Oxbryta lawsuit depends on the type and extent of injuries you suffered from SCD treatment. The types of damages typically associated with this type of lawsuit include the following, among others:
Our Oxbryta lawyers will calculate your damages and work to get you the compensation you deserve.
When you select our law firm to handle your Oxbryta lawsuit, you’re choosing a team with a proven track record of success in high-stakes pharmaceutical litigation. We have helped secure $80 billion in verdicts and settlements for our clients, holding some of the world’s largest corporations accountable for the harm they caused.
With decades of experience, our attorneys have the resources and expertise needed to tackle complex cases like the Oxbryta recall.
Our lawyers are relentless in their pursuit of justice, fighting to ensure you receive the compensation you deserve. Trust us to stand by your side every step of the way, from filing your claim to negotiating a settlement or going to trial if needed.
Oxbryta’s withdrawal follows troubling results from postmarketing clinical trials (studies conducted after a drug has been approved for use). The trials revealed a pattern of severe side effects.
Most notably, they showed an increase in vaso-occlusive crises in patients taking Oxbryta.
The clinical trials showed a higher rate of deaths in patients treated with Oxbryta compared to those in the placebo group. This significant risk prompted Pfizer to stop distributing and researching the drug.
A vaso-occlusive crisis (VOC) happens when sickled red blood cells block blood flow, cutting off oxygen to tissues. When the body tries to fix the problem, it triggers inflammation, leading to severe pain. VOC pain can occur anywhere but is most common in the back, chest, or arms and legs.
Sickle Cell Anemia News describes VOC pain in four stages:
These phases don’t always happen in the same order, and multiple VOCs can happen back-to-back without full recovery between them. Unfortunately, most treatments aimed at shortening VOCs have not been very effective.
VOC is the leading cause of hosptal visits for people with sickle cell disease. Beyond acute pain, VOCs can also cause long-term health issues, including:
The U.S. Food and Drug Administration (FDA) has been conducting a thorough review of the data from both postmarketing clinical trials and real-world registry studies.
The FDA is also analyzing reports from the FDA Adverse Event Reporting System (FAERS), which tracks side effects and adverse events in patients using FDA-approved medications.
The FDA advises healthcare professionals to stop prescribing the drug immediately. Once the review is complete, the agency will communicate any additional findings and safety recommendations.
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Hemoglobin levels help doctors understand how severe sickle cell disease is and how it may progress. Patients with lower hemoglobin levels have a higher risk of serious organ problems and early death.
In an important clinical trial for Oxbryta, researchers looked at how hemoglobin levels changed, as well as other markers that showed red blood cells breaking down. They also studied how often patients had painful vaso-occlusive crises and changes in blood flow to the brain.
The FDA decided that the improvement in hemoglobin levels shown in the trial met the standards for accelerated approval of the drug. This process allows drugs that meet urgent medical needs to be approved quickly if they show promise based on early trial results.
Oxbryta was first approved in 2019 to treat sickle cell disease (SCD) in people 12 years and older. In 2021, Oxbryta also received accelerated approval for children aged 4 to 11.
However, drugs approved this way must go through more trials after they’re on the market to confirm their safety and effectiveness. During these trials, safety issues with Oxbryta came up, leading to its removal from the market. The FDA continues to focus on monitoring drugs after approval to make sure they are both safe and helpful for patients.
Sickle cell disease (SCD) is a blood disorder that people inherit from their parents. It affects hemoglobin, the protein in red blood cells that carries oxygen throughout the body. In people with SCD, hemoglobin is abnormal, causing red blood cells to become stiff and shaped like a sickle or crescent.
These sickle-shaped cells can block blood flow, leading to anemia, pain, infections, and other serious health problems. Sickle cell disease is a lifelong condition. However, with proper treatment and care, many people with SCD can live healthy, fulfilling lives.
Oxbryta (voxelotor) is a medicine used to treat sickle cell disease. Its “mechanism of action” (how it works) is by helping hemoglobin hold onto oxygen. This stops red blood cells from becoming stiff and misshapen—a major problem in SCD.
In sickle cell disease, abnormal hemoglobin causes red blood cells to change shape and harden. These misshapen cells block blood vessels and cause many health issues. By increasing hemoglobin’s ability to carry oxygen, Oxbryta is designed to help red blood cells stay flexible and live longer. This reduces anemia and other problems patients with sickle cell disease experience.
This makes Oxbryta an important treatment option for people with sickle cell disease blood disorders.
In light of the recall, healthcare professionals are advised to stop prescribing Oxbryta immediately. The FDA encourages patients and caregivers to contact their healthcare providers to discuss alternative treatments for sickle cell disease.
The FDA has emphasized that there are other approved medications available for the management of this condition.
Patients and healthcare professionals should report any adverse events related to Oxbryta to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. This helps with monitoring safety concerns and addressing them as quickly as possible.
If you or a loved one has been affected by Oxbryta and its withdrawal from the market, you may have legal options.
Our law firm has fought for the legal rights of those injured by dangerous drugs since 1955. When you hire us to represent you in your Oxbryta lawsuit, you can rest assured we will work to get you compensation for your injuries.
Call us at (800) 277-1193 or fill out our brief Free Evaluation Form. Our legal team is standing by to fight for your rights and help you pursue justice.
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