Oxbryta Lawsuit
Pfizer’s Oxbryta has been withdrawn from global markets due to potential severe risks, including an increased chance of vaso-occlusive crises (VOCs), which result in severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues. Per the FDA, “Pfizer has determined the benefit of Oxbryta does not outweigh the risk.”
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If you or somebody you know has taken Oxbryta and has been harmed by vaso-occlusive crises, organ damage, or death, contact the attorneys at Harding Mazzotti, LLP for a free case consultation at 1-800-LAW-1010.
About Oxbryta
Oxbryta, was once known for its promise in treating sickle cell disease-related anemia. Per the FDA, “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.” Pfizer initiated a voluntary global market withdrawal. Individuals experiencing vaso-occlusive crises (VOCs) are now seeking legal recourse, claiming that they were not adequately warned about these risks.
What is sickle cell disease?
According to the National Heart, Lung, and Blood Institute, sickle cell disease, also known as sickle cell anemia, is “a group of inherited disorders that affect hemoglobin, the major protein that carries oxygen in red blood cells.” Red blood cells are usually disc-shaped and flexible, so they are able to easily pass through the blood vessels. In individuals with sickle cell disease, red blood cells are misshapen, sometimes crescent- or “sickle”-shaped. This
is due to a gene mutation that impacts the hemoglobin molecule. The blood cells are less flexible, which can cause them to block blood flow. Sickle cell disease is a lifelong disease.
Oxbryta Manufacturer Announces Voluntary Global Withdrawal
Oxbryta was officially approved by the FDA on November 25, 2019, for adults and children aged 12 and older. After less than 5 years on the market, Pfizer initiated a voluntary global withdrawal of Oxbryta on September 25, 2024, withdrawing all lots of Oxbryta for the treatment of SCD in all markets where it was approved. Pfizer also announced the suspension of all Oxbryta clinical trials and worldwide expanded access programs.
Pfizer said that information gathered from the post-clinical trials showed that the risks of taking Oxbryta now outweigh the drug’s benefits. The drug manufacturer cited that the increased occurrence of VOCs and deaths in particular led to its decision to pull the drug from the market. Pfizer is investigating these incidents, along with regulatory authorities.
The FDA has urged patients who suffered a VOC or other adverse effect after taking Oxbryta to report it to the Adverse Event Reporting System (FAERS).
FDA Issues Oxbryta Warning
Oxbryta was voluntarily withdrawn from the market by its manufacturer, Pfizer. As soon as this happened, the FDA issued a warning to patients taking Oxbryta and their healthcare providers. The U.S. FDA issued a warning statement about the dangers of Oxbryta on September 26, 2024, alerting patients, caregivers, and healthcare professionals about the Oxbryta market withdrawal and advising patients to contact their doctors immediately to discuss alternative treatment options.
Oxbryta Lawsuit Claims
Legal claims allege that Pfizer failed to adequately inform patients and medical providers about the potential severe risks of Oxbryta. Litigants report adverse effects that include vaso-occlusive crises, stroke, and organ damage, and seek compensation for their medical bills, lost wages, emotional suffering, and more.
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Eligibility Criteria for Filing an Oxbryta Claim
If you or a loved one has suffered from any of the following while taking Oxbryta, don’t wait; call today.
- Vaso-occlusive crises
- Organ damage
- Death
If you or a loved one used Oxbryta and experienced vaso-occlusive crises, organ damage, or death, contact the experienced Oxbryta injury lawyers at Harding Mazzotti, LLP today for a free case evaluation. Click, Chat, or call 1800LAW1010 24/7 for a free consultation.
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