Oxbryta (voxelotor) is a hemoglobin S polymerization inhibitor intended to help hemoglobin hold onto oxygen and prevent the deformation and breakdown of red blood cells in patients with sickle cell disease. The drug is manufactured by Pfizer, Inc. and gained FDA approval in 2019.
With few to no other effective options available on the market, Oxbryta was fast-tracked through FDA approval using the “Compassionate Use” approval process. As part of this approval, the FDA and the European Medical Association required real-world clinical trials to monitor safety.
While promising in the initial clinical trial data that has been released, sickle cell disease patients have experienced severe and dangerous side effects after taking the drug.
On September 25, 2024, Pfizer issued a voluntary recall of the drug, stating that “the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population.”
Unfortunately, many Oxbryta users have experienced vaso-occlusive events and fatal complications, such as:
Rheingold, Giuffra, Ruffo, Plotkin & Hellman, LLP is currently representing clients across the country who have been injured or suffered a fatal complication after taking Oxbryta. Our nationally recognized attorneys have litigated serious injury cases in the past, recovering over $2 billion for our clients.
Our team serves victims of defective drugs across the nation. Call (212) 684-1880 to learn more during a free and confidential consultation.
Sickle cell anemia is a genetic blood disorder that affects the red blood cells, causing them to take on a rigid, sickle-like shape. Normally, red blood cells are round and flexible, allowing them to move easily through blood vessels and deliver oxygen throughout the body. In sickle cell anemia, the abnormal hemoglobin (the protein that carries oxygen) causes red blood cells to become misshapen, sticky, and prone to clumping.
These sickle-shaped cells can block blood flow, leading to episodes of severe pain called vaso-occlusive crises. The condition also results in chronic anemia because the sickle cells break down more quickly than normal red blood cells. Sickle cell anemia can cause various complications, including infections, strokes, organ damage, and an increased risk of early death. It is inherited from both parents who carry the sickle cell gene, and it primarily affects people of African, Mediterranean, Middle Eastern, and Indian descent.
While the total number of cases of sickle cell disease in the US is unknown, estimates range from 72,000 to 138,900 based on birth-cohort disease prevalence.
Below is a figure created by the American Journal of Preventative Medicine, estimating the number of individuals with sickle cell disease by state.
Notably, New York, Texas, and Florida are estimated to have the highest prevalence of sickle cell disease.
While mild side effects in sickle cell patients were discussed in clinical trial literature, such as the RETRO and phase 3 HOPE trial reports, serious side effects such as sickle cell anemia with crisis and fatal adverse events were judged to be “unrelated to the trial drug or placebo.” [Source: A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease]
Mild side effects reported include:
However, in the FDA recall statement, the following information has come to light:
“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. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies. Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk.”
Patients are being advised by Pfizer, the FDA and the European Medicines Agency to contact their prescribing physician if they are currently taking the drug.
Additionally, symptoms of vaso-occlusive injuries include:
If you or a loved one has experienced an injury or fatality after taking Oxbryta, you may be entitled to recover compensation via a lawsuit.
Injuries may include:
In successful cases, injured persons or those filing a suit for a loved one who has passed away after taking Oxbryta can recover the following types of compensation:
Our firm is currently investigating Oxbryta injury claims, trial information and lawsuit updates related to Oxbryta.
Pfizer has recalled Oxbryta (voxelotor), a sickle cell disease drug, due to reports of increased deaths and severe vaso-occlusive crises. Fast-tracked through the FDA’s compassionate use program, Oxbryta was subject to real-world clinical trials, but the full data has yet to be released. The FDA confirmed the recall, citing higher rates of adverse events and deaths in Oxbryta users. Both the FDA and the European Medical Association flagged safety concerns, while patients also experienced side effects like headaches and fatigue without significant health improvements. Ongoing studies are expected to provide more insight, and affected individuals are encouraged to explore legal actions. Read the full blog.
Pfizer has issued an urgent global recall of Oxbryta, a drug used to treat hemolytic anemia in sickle cell disease patients, due to reports of severe side effects, including vaso-occlusive crises, arthritis, kidney failure, stroke, and death. Both the FDA and the European Medicines Agency have advised patients to stop using the drug and consult their doctors. Read more.
At Rheingold Giuffra Ruffo Plotkin & Hellman LLP, we have served clients throughout New York and nationwide since 1971. We have a long record of successful results, winning settlements and jury awards for people who have been harmed by dangerous drugs and other defective products, as well as those who have lost loved ones due to a wrongful death.
Drug manufacturers are expected to ensure their products are safe. If this responsibility has not been met and you were injured by a pharmaceutical, call (212) 684-1880 for a free consultation with our nationwide dangerous drug attorneys.
We fight tirelessly to deliver results and we are not afraid to go to trial.
We are leaders and educators in legal issues involving personal injury, medical malpractice, and product liability.
We have the experience to handle your case all while providing individualized attention.
