Oxbryta Attorneys
Oxbryta, a medication designed to manage sickle cell disease by enhancing oxygen retention in red blood cells, has recently faced recalls and lawsuits, raising concerns about its safety and efficacy. Patients taking Oxbryta have reported adverse effects, including liver toxicity, worsened anemia, headaches, gastrointestinal issues, and occasional hypersensitivity reactions. These health risks have prompted some patients and their families to pursue legal action, citing insufficient warnings about potential side effects and concerns over inadequate testing prior to the drug’s approval.
If you or a loved one have experienced complications from Oxbryta, don’t wait to get the help you deserve. Contact Farah & Farah today for a free consultation and let our experienced team of attorneys review your case and guide you on the best path forward.
What Is Oxbryta?
Oxbryta (voxelotor) is a prescription medication developed to treat sickle cell disease (SCD) by increasing hemoglobin levels, which helps reduce the risk of vaso-occlusive crises (painful episodes caused by the blockage of blood vessels). Although it was hailed as a breakthrough treatment when it gained FDA approval in 2019, some patients have experienced severe health complications while taking Oxbryta, leading to lawsuits against the medicine’s producer, Pfizer.
Who Developed Oxbryta?
Global Blood Therapeutics (GBT) was founded in 2011 to develop innovative treatments for underserved populations suffering from blood disorders. Oxbryta was the company’s breakthrough drug, designed specifically to address the underlying cause of sickle cell disease. Pfizer, best known for developing one of the COVID-19 vaccines, acquired GBT in 2022.
Milestones in Oxbryta’s Development
Global Blood Therapeutics was founded in 2011. However, it wasn’t until 2019 that Oxbryta was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for treating sickle cell disease in patients aged 12 years and older. This approval was significant, as it represented the first drug to address the underlying causes of SCD. Previous medications had simply managed symptoms. In 2021, the FDA broadened the drug’s reach by approving it to treat children above four years old.
Does GBT Still Own Oxbryta?
In 2022, GBT became a subsidiary of Pfizer with a $5.4 billion buyout. The purchase of GBT gave Pfizer official ownership of Oxbryta, adding to its portfolio of treatments for rare diseases.
How Does Oxbryta Work?
Oxbryta works by binding to hemoglobin, the protein in red blood cells that carries oxygen. In SCD, hemoglobin tends to polymerize (clump together), causing the cells to deform into a sickle shape. Oxbryta reduces this polymerization, helping red blood cells retain their normal, flexible shape. Voxelotor also increases the hemoglobin’s ability to hold onto oxygen, which improves oxygen delivery throughout the body.
Is Oxbryta FDA-Approved?
Oxbryta received approval under the FDA’s Accelerated Approval Program. The program is designed to speed up drug approval for medications that treat serious conditions lacking sufficient treatment options. It allows drug manufacturers to use test results that are more quickly obtained—like improved blood tests—rather than waiting for long-term clinical outcomes. While this fast-tracks the availability of drugs, it can also mean that side effects may emerge after the drug has been approved.
The FDA Accelerated Approval Program for Oxbryta
Oxbryta was approved based on its ability to improve hemoglobin levels in sickle cell patients. Long-term clinical benefits—such as reduced vaso-occlusive crises (VOCs) or organ protection—were not fully established at the time of approval. Following its release, GBT was required to conduct additional trials to confirm the drug’s safety and effectiveness. The ongoing studies may influence whether Oxbryta remains on the market. Meanwhile, the FDA has been monitoring and issuing updates to healthcare providers and patients regarding potential risks associated with the drug.
What Does Oxbryta Treat?
Oxbryta was developed to treat sickle cell disease (SCD) by improving the oxygen retention of hemoglobin in red blood cells, helping them maintain a normal shape and flexibility. This reduces cell sickling and breakdown, aiming to alleviate anemia, prevent painful blockages, and decrease the risk of organ damage associated with SCD.
What Is Sickle Cell Disease?
Sickle cell disease (SCD) is a genetic blood disorder that affects the structure and function of red blood cells. In healthy individuals, red blood cells are round, soft, and flexible, allowing them to move quickly through blood vessels to deliver oxygen throughout the body. However, in individuals with SCD, red blood cells become stiff, sticky, and crescent-shaped (resembling a sickle). This irregular shape causes blockages in blood vessels, restricting oxygen supply to vital tissues and organs and leading to serious health complications.
Some of the common symptoms of sickle cell disease include:
- Episodes of severe pain
- Swelling in the hands and feet (especially in children)
- Frequent infections
- Delayed growth and development
- Vision problems
- Persistent fatigue and weakness
Complications of Sickle Cell Disease
Individuals with sickle cell disease can experience a range of symptoms and complications. These can include vaso-occlusive crises, chronic anemia, increased risk of stroke and organ damage, and frequent infections.
Vaso-Occlusive Crises (VOCs)
VOCs are painful episodes that occur when sickled cells block blood flow. The lack of oxygen to tissues can result in severe pain that may last for hours or days.
Chronic Anemia
Sickled cells break down faster than normal red blood cells, leading to a shortage of healthy cells (anemia). This anemia causes fatigue, shortness of breath, and slowed growth in children.
Increased Risk of Stroke and Organ Damage
The blockages caused by sickled cells can lead to strokes. Additionally, blockages in blood vessels can damage critical organs, including the kidneys, liver, and lungs.
Infections
Individuals with SCD are also more prone to infections. This condition occurs when sickled cell blockages damage the spleen, an essential part of the immune system.
Why Are People Suing Pfizer?
Patients who were prescribed Oxbryta have filed lawsuits against the drug’s manufacturer after experiencing adverse side effects. Claimants state they should have been warned about these side effects. The main allegations in these lawsuits include failure to warn, negligence, and defectiveness.
Failure To Warn
Patients claim they were not adequately informed of the risks of taking Oxbryta, particularly regarding life-threatening side effects.
Negligence
Claimants also allege that the manufacturer failed to test the drug, leading to unforeseen complications properly.
Defective Drug
Some lawsuits suggest that Oxbryta is inherently dangerous due to its potential to cause organ damage and other severe health outcomes.
Serious Health Risks Related to Oxbryta
Oxbryta was introduced to the market as a solution to reduce the complications of sickle cell disease. However, patients who took the drug have reported a variety of side effects, ranging from mild to severe. Some of the most common side effects felt by patients were headaches, nausea, diarrhea, fatigue, fever, and abdominal pain.
Injuries and Complications Linked to Oxbryta
Patients who took Oxbryta and experienced significant health issues may be eligible to file a lawsuit. The most commonly reported injuries linked to Oxbryta include:
Increased Vaso-Occlusive Crises (VOCs)
Ironically, while Oxbryta is designed to reduce VOCs, some patients have reported an increase in these painful episodes, which can lead to hospitalization.
Kidney Failure
Several lawsuits have been filed by patients who suffered kidney failure while taking Oxbryta, claiming the drug contributed to the deterioration of renal function.
Other Organ Failure
In some cases, Oxbryta has been linked to liver or heart failure, posing life-threatening risks.
Infection
Some patients on Oxbryta have reported severe infections, which may be due to the drug’s impact on the immune system.
Stroke
Individuals with sickle cell disease are already at an elevated risk of stroke, but some lawsuits allege that Oxbryta increased the likelihood of this devastating outcome.
Death
Tragically, there have been cases where patients died while taking Oxbryta, either due to the drug itself or complications resulting from it.
Pfizer Voluntarily Recalled Oxbryta
In September 2024, Pfizer volunteered to withdraw Oxbryta from all markets globally. The company has emphasized that it continues to prioritize patient safety and is committed to conducting further research into treatments for SCD. Pfizer has assured patients and healthcare providers that they cooperate with regulatory authorities, including the FDA, to address concerns about Oxbryta’s risks. Pfizer will still support studies to explore better therapies for sickle cell disease. No formal statements about Oxbryta’s potential return to market have been made since the drug’s withdrawal.
Will Oxbryta Be Used in the Future?
Pfizer’s acquisition of Oxbryta signaled a strong interest in expanding its rare disease portfolio, particularly in SCD treatment. While Oxbryta is no longer on the market, the need for effective treatment options for patients with SCD remains critical. Future developments in sickle cell treatment will likely depend on ongoing research, FDA assessments, and the outcomes of legal proceedings related to Oxbryta.
What Do I Do Now That Oxbryta Is Recalled?
When Pfizer and the FDA announced the withdrawal of Oxbryta from the market, the National Alliance of Sickle Cell Centers and other centers, like the Sickle Cell Disease Association of America, asked patients to set a plan with their doctor to taper off Oxbryta. Patients should seek alternative treatments, keep up to date with emerging therapies, and manage pain to prevent complications. Staying proactive about your healthcare and knowing your options will help ensure you continue receiving the treatment and support you need to manage sickle cell disease effectively.
Consult Your Doctor
Your healthcare provider is your first point of contact. They can assess your current health condition, review your treatment history, and guide alternative therapies or medications to manage SCD effectively.
Updates and Future Developments in Oxbryta Litigation
Oxbryta-related lawsuits are still in the early stages, but several important developments are unfolding. To streamline the legal process, a growing number of cases may be consolidated into a multidistrict litigation (MDL).
Stay Aware of Changes to Oxbryta Lawsuits
Some key updates to look out for in the Oxbryta lawsuits are litigation status, new scientific research, and class actions vs. individual lawsuits against Pfizer. Litigation status will explain where and how lawsuits are moving through the legal system. Some cases may settle out of court, while others could go to trial. Understanding whether Oxbryta lawsuits will be handled as class actions (where multiple plaintiffs share the same legal complaint) or as individual cases is important. Ongoing studies will determine the long-term effects of Oxbryta, which may impact future litigation and settlement offers.
Your Path to Justice Starts With Farah & Farah’s Experienced Pharmaceutical Lawyers
If you or a loved one have suffered due to complications from Oxbryta, you deserve to know your rights. At Farah & Farah, we are here to support you through the pain and frustration that comes with experiencing severe side effects from a drug you trusted. Our knowledgeable legal team can guide you through every step of the process and fight for the compensation you deserve. If you believe you have a case, contact Farah & Farah today for a free consultation. Our experienced attorneys will review your situation, explain your options, and help you pursue justice.
Do I Have an Oxbryta Case?
If you or a loved one has been hospitalized due to injuries sustained from taking Oxbryta, you may have a case against Pfizer. Qualifying injuries include increased vaso-occusive crises, kidney failure, other organ failure (heart, liver, etc.), serious infections, stroke, or death. Pharmaceutical companies have a responsibility to ensure that their medications are safe. Farah & Farah is here to help hold those companies accountable for harm they’ve caused when they don’t fulfill that responsibility.
Farah & Farah’s legal team is highly experienced with defective drug lawsuits and can help you fight the company that manufactured the drug that harmed you. Don’t wait to get the justice and compensation you deserve. Contact Farah & Farah today for a free consultation. You pay nothing unless your case is successful.
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