Pfizer pulled the sickle cell treatment Oxbryta® off the market due to safety concerns, severe side effects, and deaths.
Need a Texas Oxbryta Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were diagnosed with a severe side effect or a loved one died after taking Oxbryta for sickle cell disease, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Sickle Cell Drug Oxbryta Pulled Off Market for Safety Risks
In September 2024, Pfizer announced that it would voluntarily withdraw the sickle cell disease medication Oxbryta® (voxelotor) due to safety concerns, deaths, and higher rates of a painful condition called vaso-occlusive crisis (or a “sickle cell crisis”).
What is Oxbryta?
Oxbryta® (voxelotor) is a once-daily pill for the treatment of sickle cell disease that is manufactured by Pfizer. It was approved by the FDA in November 2019 for people aged 12 years and older.
FDA Expands Oxbryta Approval for Young Children
In 2021, the FDA granted accelerated approval for Oxbryta to be used in children as young as 4 years old.
This fast-track approval was based on a small study involving 45 children between the ages of 4 and 11 years old. In the study, 36% of patients reached a target hemoglobin increase after taking Oxbryta.
As a condition of the expanded approval, the FDA ordered Pfizer to continue studying the risks, benefits, and effectiveness of Oxbryta in an ongoing clinical trial. The FDA also cautioned: “Further clinical trials are required to verify and describe Oxbryta’s clinical benefit.”
Pfizer Discovers Oxbryta Safety Concerns In Clinical Trials
Unfortunately, Pfizer discovered safety concerns during an ongoing clinical trial for Oxbryta, including higher rates of deaths and vaso-occlusive crisis. In addition, two real-world registry studies also found higher rates of vaso-occlusive crisis for patients receiving Oxbryta.
Pfizer warned: “Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk.”
FDA Warns About Serious Risks Of Oxbryta
According to the FDA Safety Communication on September 26, 2024:
“In postmarketing clinical trials of Oxbryta, Pfizer reported 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 with sickle cell disease receiving Oxbryta compared to placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these postmarketing studies.”
What Is Vaso-Occlusive Crisis?
The most common complication of sickle cell disease is a vaso-occlusive crisis, also known as a “sickle cell crisis.” It is an extremely painful complication that is caused when abnormal red blood cells block the flow of blood to the body.
What Happens In People With Sickle Cell Disease?
Sickle cell disease causes the red blood cells to change shape. Normal red blood cells are a round disc-shape, but sickle cells are crescent or C-shaped, like a farm tool called a sickle.
The abnormal sickle cells are hard and sticky, rather than flexible and smooth, which makes it hard for them to move through blood vessels.
Sickle Cell Anemia
Sickle cells break apart and die more easily, which forces the body to work harder to make new red blood cells. The persistent lack of healthy red blood cells is why this disease is also called “sickle cell anemia.” Sickle cells usually only last for 10 to 20 days, instead of the normal 90 to 120 days. People with sickle cell disease often feel tired due to anemia and the extra work-load on the body to make new cells.
What Happens During A Sickle Cell Crisis?
During an episode of severe pain caused by a sickle cell crisis, the abnormal sickle-shaped red blood cells get clogged in the smallest blood vessels. This blocks the delivery of oxygen to the body, causing severe pain and other serious complications, such as ischemic injury to organs and tissues.
The sickle-shaped red blood cells can get stuck to the walls of blood vessels, causing a blockage that slows or stops blood circulation. The lack of oxygen causes episodes of severe pain and inflammation.
Can I File A Lawsuit?
Our law firm is investigating cases involving adults and children with sickle cell disease who were injured or died after taking Oxbryta.
This medication is under investigation for severe side effects, including sickle cell crisis, vaso-occlusive crisis, and even death. Any potential liability issues could result in lawsuits or class actions.
For example, lawsuits might be filed by people who were injured by a medication if the manufacturers did not warn patients about the risk of a severe side effects. There may be thousands of lawsuits or plaintiffs.
What Do Lawsuits Claim?
Lawsuits involving defective medications typically accuse pharmaceutical companies of “negligence,” which is a legal term for failing to properly warn patients and doctors about the risk of side effects that they knew about (or should have known about).
How Much Is My Lawsuit Worth?
In these circumstances, patients may be eligible to file a lawsuit and seek justice or financial compensation. The payout may involve damages for pain and suffering, medical expenses, lost income, long-term injuries, the wrongful death of a loved one, and more.
Need an Oxbryta Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.
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