Oxbryta Medication Recall for Sickle Cell Disease
In September 2024, Pfizer Inc. published a press release announcing it voluntarily recalled all Oxbryta (Voxelotor). Oxbryta was used to treat sickle cell disease and was once thought of as a breakthrough treatment for the deadly disorder.
The following day, the United States Food & Drug Administration (FDA) published a safety alert regarding Pfizer’s recall. It recommended that healthcare providers stop prescribing the drug and that patients contact their doctors. The FDA’s safety alert explained that Oxbryta was recalled because of severe adverse side effects in Oxbryta treatment groups relative to controls.
You may be entitled to compensation if you experienced severe adverse reactions after taking Pfizer’s Oxbryta. Contact the experienced defective drug lawyers at The Yost Legal Group today for a free consultation regarding your claim. We are available by phone or text at 410-659-6800.
Oxbryta Recall Linked to Vaso-Occlusive Crises – Find the Facts
Two FDA-mandated studies have revealed a concerning risk associated with Oxbryta. Research shows that Oxbryta may increase the likelihood of experiencing a life-threatening vaso-occlusive crisis, a condition that can result in organ failure, stroke, or even death.
Following these findings, the FDA has concluded that the risks of Oxbryta outweigh its benefits. Symptoms of vaso-occlusive crisis may include:
- Fever
- Pain
- Swelling
- Kidney Failure
- Stroke
- Death
If you or a loved one have taken Oxbryta and suffered severe side effects, it’s important to act now. Consult your healthcare professional and contact our product liability lawyers for guidance.
Our experienced product liability attorneys are ready to help you understand if you qualify to join the Oxbryta lawsuit.
The Benefit of Pfizer Sickle Cell Drug “No Longer Outweighs the Risk”
Pfizer, a multinational biopharmaceutical giant valued at over $140 billion, markets itself as “one of the world’s premier biopharmaceutical companies.” With such immense resources, it’s no surprise that Pfizer has a legal team to match its stature, prepared to defend the company at all costs.
But what about the individuals harmed by Big Pharma’s actions? If you’ve been negatively impacted, you need an experienced, compassionate, and relentless legal team—someone who will stand up to billion-dollar corporations and fight for justice on your behalf.
At The Yost Legal Group, we’ve advocated for ordinary people for over 35 years. Our defective drug attorneys have fought—and won—against some of the largest pharmaceutical companies for our clients, ensuring they receive the justice they deserve.
Pfizer prioritized profits over safety, putting lives at risk to fast-track its drug. It’s time to hold the drug manufacturers accountable. Contact The Yost Legal Group today for a free consultation.
What Is Sickle Cell Disease?
The recalled drug Oxbryta is the brand name of Voxelotor, a medication used to treat sickle cell disease (SCD). SCD is a group of blood disorders that affect the hemoglobin. You might be most familiar with sickle cell disease, which is known as sickle cell anemia.
This is all very technical and heavy on medical terminology, so we will go through each portion piece by piece.
First, we will discuss hemoglobin: It is easy to think of blood as just one substance, a bodily fluid that flows through all of us. But blood comprises many other substances, such as nutrients and oxygen. There are red blood cells. There are white blood cells.
In red blood cells, a protein rich in iron called hemoglobin facilitates the transportation of oxygen from the respiratory organs (lungs or gills) to the body’s other tissues.
However, due to a gene mutation, sickle cell disease occurs when a person inherits two abnormal copies (one from each parent) of the gene that makes hemoglobin. The red blood cells adopt an abnormal sickle-like shape, giving the disorder group its name.
These misshapen red blood cells cause many health issues, such as anemia, bacterial infections, and capillary blockages. Furthermore, all of the significant organs suffer as these deformed red blood cells pass through the body, causing attacks of pain known as “sickle cell crisis.”
Sickle cell disease is a life-long disorder that is often fatal. Without treatment, people with SCD rarely reach adulthood. Even with treatment, though people reach adulthood and even middle age, their life expectancy is significantly lower than that of people without the disease.
What Is the Medication Oxbryta (Voxelotor)?
Oxbryta was an oral medication. Patients were meant to take one tablet daily. Its intended use was for the treatment of sickle cell disease, the hemoglobin-related blood disorder that is, at best, degenerative and, at worst, fatal even before a person reaches adulthood.
As SCD affects the shape of red blood cells and limits hemoglobin’s ability to carry oxygen from the lungs to other parts of the body, Oxbryta was developed to increase hemoglobin’s affinity for oxygen.
In November 2019, Global Blood Therapeutics (a subsidiary of Pfizer since October 2022), received an accelerated approval from the FDA for Voxelotor as a treatment for SCD patients 12 years and older, making it the first hemoglobin oxygen-affinity modulator.
It was the first drug to target the root cause of SCD. This approval was a landmark win in a long and difficult battle against the disease.
In December 2021, the FDA again granted Global Blood Therapeutics an accelerated approval for the prescription drug Voxelotor in sickle c patients between the ages of four and 11.
However, the actual results of the trials were not so conclusive.
Oxbryta Medication Recalled by the FDA
On September 25, 2024, Pfizer, the parent company of Global Blood Therapeutics, the original developer of Voxelotor for nearly two years, withdrew all lots of Oxbryta from worldwide markets.
This recall sent shockwaves through the SCD community five years after the initial breakthrough approval. “Clinicians and patients were shocked to hear that the drug was being withdrawn from the market because of safety concerns.”
According to Pfizer’s own press release:
“Pfizer’s decision is based on 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. The data suggests an imbalance in vaso-occlusive crises and fatal events which require further assessment.”
Despite this, many clinicians were still left with more questions as Pfizer did not provide many details to support its claims: “Specifically, the letter noted that the decision was based on the ‘totality of clinical data,’ but did not provide any details on adverse events.”
Charles Abrams, MD, the Francis C. Wood professor of medicine at the University of Pennsylvania School of Medicine, used the opportunity to call into question the FDA’s accelerated approval pathway:
“[Accelerated approval] has always been a double-edged sword. Certainly, it accomplished the idea of getting drugs out there and utilized more quickly. Some drugs that have been approved through this pathway have later been proved to be ineffective and sometimes even unsafe for patients.”
In the intervening time, the European Medicines Agency (EMA) has also recommended the suspension of Oxbryta based on new data from a study that has been ongoing since July 2024.
Injured by Oxbryta? Call for Free Legal Help Today!
Similar to Pfizer, the EMA cited an increase in vaso-occlusive crises in patients taking Oxbryta compared to before they started the treatment.
There is still much to learn, but it is clear that Pfizer had a dangerous drug on the market for about five years. If you have been prescribed Oxbryta, consult with your healthcare professional to discuss a plan for getting off the recalled drug.
If the use of Oxbryta, the sickle cell anemia drug, has harmed you or a loved one, you may have a case. Call the experienced defective drug lawyers at The Yost Legal Group for a free consultation. We are available by phone or text at 410-659-6800 or toll-free at 1-800-659-6800.
When your health and safety are on the line, there is no time to delay. Contact an Oxbryta lawyer who will fight for your rights and help you get the justice you deserve.
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