On September 26, 2024, the U.S. Food & Drug Administration (FDA) announced that manufacturer Pfizer, Inc., issued a voluntary recall of Oxbryta due to safety concerns. (1)
Oxbryta was approved by the FDA, through an expedited process, in 2019 for adults and children 12 years and up with sickle cell disease. In 2021, FDA granted accelerated approval for patients who are 4 to 11 years old. (2)
“Pfizer knows this is a defective drug. That is why they have pulled it from the market. The company rushed their drug through the FDA approval process to get it on the market without adequate study. They should be held accountable for the harm their product has inflicted on sickle cell patients. No medication — intended to help people — should cause more pain and suffering to those already suffering enough,” says our co-counsel’s distinguished defective medicine litigator.
In making the announcement, Pfizer said, “recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.” Findings by Pfizer showed a higher rate of vaso-occlusion crisis and more deaths among patients taking the drug than those taking a placebo. (3)
Patients taking Oxbryta should consult their doctors immediately regarding whether to stop taking their medication or not.
The terrible complications of sickle cell disease are numerous. Some can affect the entire body. Among these are: vaso-occlusion, chronic pain, vitamin deficiency, delayed growth and puberty, infections, joint problems, blood clots, and pregnancy issues. (6)
Complications affecting specific parts of your body include acute chest syndrome (when lungs are deprived of oxygen), enlarged spleen, eye problems, gallstones, heart problems, kidney problems, leg ulcers, liver problems, priapism, stroke, and silent brain injury (damage to the brain without outward signs or symptoms of stroke). (7)
Sickle cell disease is a blood disorder that distorts the shape of red blood cells, impeding the delivery of oxygen throughout the body. Vaso-occlusion is “severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues.” (8)
Sickle cell anemia affects the hemoglobin in red blood cells. Hemoglobin is a protein that allows red blood cells to carry oxygen. Normal red blood cells are disc-shaped and flexible, allowing them to move easily through blood vessels. Sickle cell anemia causes these cells to become misshaped, like crescents or sickles. Sickling causes pain and impedes oxygen delivery to the body. Oxbryta was supposed to prevent the sickling of red blood cells. (9)
Sickle cell disease is a blood disorder that distorts the shape of red blood cells, impeding the delivery of oxygen throughout the body. Vaso-occlusion is “severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues.” (8)
We are investigating cases of sickle cell patients harmed by the medication Oxbryta (voxelotor). We encourage you to reach out to us if you have experienced an additional vaso-occlusion crisis after taking this medication, or if a loved one has died.
Please contact us by calling (855)769-1766. We offer a free initial consultation and respond quickly to all inquiries.
Our co-counsel team of defective drug attorneys are always ready to take on drug companies, anywhere in the country, whose products harm vulnerable people. We have been holding large companies and manufacturers accountable for over four decades. We can assist you in considering all of your legal options.
A lawsuit can be filed on your behalf (pursuant to several key criteria), so that you may obtain compensation for your injuries. We understand the suffering you have endured, and we fight to ensure that you get the optimal compensation the law allows in your case.
Our co-counsel has a solid history of winning cases for clients. We are ready to take on this fight for you.
Our co-counsel team of defective drug attorneys are always ready to take on drug companies, anywhere in the country, whose products harm vulnerable people. We have been holding large companies and manufacturers accountable for over four decades. We can assist you in considering all of your legal options.
A lawsuit can be filed on your behalf (pursuant to several key criteria), so that you may obtain compensation for your injuries. We understand the suffering you have endured, and we fight to ensure that you get the optimal compensation the law allows in your case.
Our co-counsel has a solid history of winning cases for clients. We are ready to take on this fight for you.
© 2025 SARABETH KUFELD, ESQ. ATTORNEY ADVERTISING. PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. OFFICE MAILING ADDRESS: SUITE 224, 16 MIDDLE NECK ROAD, GREAT NECK, NY 11021 DO NOT DISCONTINUE TAKING PRESCRIBED MEDICATIONS UNLESS YOU FIRST CONSULT YOUR DOCTOR. YOU ARE NOT CONSIDERED A CLIENT UNTIL YOU HAVE SIGNED A RETAINER AGREEMENT.
OUR CO-COUNSEL IN THIS LITIGATION IS ONE OF THE USA’S LARGEST, MOST EXPERIENCED AND MOST PROLIFIC (IN TERMS OF TOTAL VERDICTS AND SETTLEMENTS ACHIEVED) MASS TORT LITIGATION FIRMS, WEITZ & LUXENBERG P.C.