Oxbryta is a medication for sickle cell disease that was pulled off the market due to serious safety concerns, such as higher rates of death and vaso-occlusive crisis.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Oxbryta induced injury cases in all 50 states. If you were diagnosed with severe side effects or a loved one died after taking Oxbryta, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Oxbryta Pulled Off Market for Safety Concerns
In September 2024, Pfizer pulled Oxbryta off the market due to safety concerns, including higher rates of death and a painful condition called vaso-occlusive crisis that was observed in multiple studies.
Pfizer explained: “The data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment. Pfizer’s decision is based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk.”
What Happened?
Oxbryta® (voxelotor) is a treatment for sickle cell disease that was voluntarily withdrawn by Pfizer after studies showed that “the benefit of Oxbryta does not outweigh the risk.”
Pfizer observed these serious safety risks in multiple clinical trials and studies involving patients with sickle cell disease who used Oxbryta.
During a post-marketing clinical trial of Oxbryta that was required by the FDA, Pfizer observed a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients who were using Oxbryta compared to a placebo.
There were also more deaths in the treatment group of patients who used Oxbryta compared to patients who used a placebo, Pfizer said.
Pfizer Asks Doctors to Stop Prescribing Oxbryta
Pfizer asked doctors to stop prescribing Oxbryta to new patients. The company will remove Oxbryta from the market, stop distribution, discontinue all clinical trials, and end expanded access programs, according to the FDA Safety Communication for patients and health care professionals.
What Should Patients Do?
Patients who are taking Oxbryta should contact their health care provider about stopping Oxbryta and switching to an alternative FDA-approved medication for the treatment of sickle cell disease.
What is Oxbryta?
Oxbryta® (voxelotor) is a treatment for sickle cell disease that was approved in 2019 for adults and children 12 years of age and older.
FDA Fast-Tracks Approval for Oxbryta in Young Children
In 2021, the FDA allowed Pfizer to use an “accelerated approval” process to expand Oxbryta’s approval to patients as young as 4 years old. As a condition of this fast-track approval, the FDA asked Pfizer to conduct a post-marketing clinical trial to study the risks and benefits.
Unfortunately, post-marketing clinical trials observed higher rates of vaso-occlusive crisis and death for patients on Oxbryta compared to a placebo. Two real-world registry studies also observed higher rates of vaso-occlusive crisis in patients with sickle cell disease on Oxbryta.
Pfizer said, “recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.”
FDA Opens Safety Review For Oxbryta
The FDA said it will also conduct a safety review for Oxbryta and “communicate any additional findings, if necessary.” The review will include adverse event reports that were submitted to the FDA, as well as the post-marketing clinical trials and the real-world registry studies.
What is Sickle Cell Disease?
Sickle cell disease is a rare and serious genetic blood disorder that causes red blood cells to be misshapen. Red blood cells are normally round and flexible, so they move easily through blood vessels. Sickle cell disease causes the red blood cells to be hard, sticky, and C-shaped like a farm tool called a “sickle.”
What is Vaso-Occlusive Crisis?
Abnormal red blood cells do not bend or move easily, so they can block blood-flow to the rest of the body. This is an extremely painful complication called a “vaso-occlusive crisis” or “sickle cell crisis.”
How Is Sickle Cell Disease Treated?
Sickle cell disease is caused by a genetic mutation that a person inherits from their parents. It is a lifelong illness, but the symptoms can be managed with medications and other treatment options.
The FDA has approved several medications that treat different aspects of sickle cell disease, including hydroxyurea, L-glutamine, and crizanlizumab‑tmca. Treatment may also involve blood transfusions, pain medication, gene therapy, or blood and bone marrow transplants.
Can I File An Oxbryta Lawsuit?
Oxbryta was advertised as a way to help people with sickle cell disease. Instead, it has been linked to life-threatening side effects. Our law firm is investigating potential Oxbryta lawsuits for people with sickle cell disease who were diagnosed with severe side effects, vaso-occlusive crisis, sickle cell crisis, or family members of people who died after using Oxbryta.
How Can A Lawyer Help Me?
If you were injured by Oxbryta, our lawyers can investigate your case and determine if you may qualify to file a lawsuit or join a class action. This litigation is still in the early stages. Lawyers are reviewing cases and investigating any potential liability issues involved with Oxbryta.
How Much Is My Lawsuit Worth?
There is no way to know if a lawsuit will result in a settlement or a financial payout for people who were injured, but typically, lawsuits involving people who were injured by medications will seek compensation for pain and suffering, medical expenses, long-term injuries, lost income, or the wrongful death of a loved one.
Do I Have an Oxbryta Lawsuit?
The Schmidt Firm, PLLC is currently accepting Oxbryta induced injury cases in all 50 states. If you were diagnosed with severe side effects or a loved one died after taking Oxbryta, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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