An FDA notice for the Oxbryta recall published on September 26, 2024, revealed that Pfizer Inc., the manufacturer of Oxbryta, voluntarily withdrew the medication from the market, “ceasing distribution, and discontinuing all active clinical trials and expanded access programs for Oxbryta.” What is Oxbryta, exactly, and why did the manufacturer take such an extraordinary step to recall the medication entirely?
What is Oxbryta?
“Oxbryta is a medicine used to treat haemolytic anaemia (excess breakdown of red blood cells) in patients aged 12 years and older who have sickle cell disease,” the European Medicines Agency reported. “Oxbryta can be given on its own or together with another medicine for sickle cell disease called hydroxycarbamide.”
It is also called Voxelotor, and the Cleveland Clinic noted, “Voxelotor treats sickle cell disease. This condition affects your red blood cells, and makes it difficult for hemoglobin to easily pass through your blood vessels. Hemoglobin is the main component of red blood cells.”
The EMA also reported, “The active substance in Oxbryta, Voxelotor, works by improving the ability of the hemoglobin to hold on to oxygen, and preventing it from forming chains. This helps the red blood cells to maintain normal shape and flexibility, reducing their excess breakdown and improving their lifespan.”
Oxbryta is prescribed to treat sickle cell disease and was developed to improve the lives of those struggling with it. However, it was recalled in September 2024.
Why Was Oxbryta Recalled?
“Recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population,” an FDA notice for the Oxbryta recall disclosed.
“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,” the notice continued.
Unfortunately, there were more deaths in the Oxbryta treatment group when compared to the placebo group in the aforementioned 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,” the notice said. “Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk.”
While there are, thankfully, other FDA-approved medications for the treatment of sickle cell disease, for many, the damage has already been done. If you or a loved one was harmed due to the use of Oxbryta to treat sickle cell disease, you may want to consider pursuing an Oxbryta lawsuit.
Contact Phillips Law Group for Oxbryta Legal Assistance
Please contact us today for a free, no-obligation consultation with an Oxbryta recall lawyer if you or a loved one faced negative impacts on your health due to the use of the medication. Our team can help you determine your legal options and whether or not you’re eligible to pursue an Oxbryta claim. Call 602-222-2222 to learn more now.
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