Oxbryta Lawsuit

Oxbryta (voxelotor) was a medication used to treat sickle cell disease. It was a daily pill that helped the blood carry more oxygen by making hemoglobin — the protein in red blood cells — work better. It also prevented the sickle-shaped deformities in those cells.

However, after 16 people taking Oxbryta died in two clinical trials, Pfizer issued a worldwide Oxbryta recall and took the drug off the market in September 2024.

“Oxbryta was advertised as a drug that would ‘reduce sickling and help red blood cells deliver oxygen throughout your body,’” Laura Baughman, a drug and medical device attorney with Weitz & Luxenberg, told Drugwatch. “Sadly, for individuals suffering from sickle cell disease, the drug does the opposite — it reduces the delivery of oxygen throughout the body and causes pain.”

The clinical trials found that patients who took Oxbryta experienced higher rates of death and severe pain episodes known as vaso-occlusive crises (VOCs) than those who received a placebo. Pfizer deemed these risks more significant than any benefits the drug could provide.

The FDA approved Oxbryta in 2019 for treating sickle cell disease in adults and children aged 12 and older, and in 2021, the agency expanded approval to those aged 4 to 11.

The FDA granted these approvals through its “accelerated approval” process due to the drug’s potential benefits for serious health issues. However, the process requires further studies to confirm a drug’s safety and effectiveness, and those aftermarket studies revealed serious problems with Oxbryta.

Clinical Trial Fatalities Led to Oxbryta Recall

Pfizer noted that two clinical studies showed worrying findings connecting Oxbryta to an increase in pain and deaths among patients. “Their studies found that Oxbryta more than doubled the rate of VOCs and deaths in people taking the drug,” Baughman said.

There is no evidence that Oxbryta directly caused the deaths, as most of the fatal cases were due to infections like malaria or sepsis. However, researchers suspended both studies, and Pfizer ordered a worldwide market withdrawal of the drug.

Vaso-Occlusive Crises and Other Oxbryta Side Effects

In addition to an increased risk of death, the clinical trials found a higher rate of vaso-occlusive crises (VOCs) — a common type of sickle cell crisis. VOCs happen when the sickle-shaped red blood cells block small blood vessels in your body, cutting off blood flow to critical organs and tissues. This can cause severe pain and complications.
By increasing the risk of VOCs, Oxbryta may trigger several conditions typically associated with these crises.

Before the market withdrawal, many common side effects were relatively minor. The Oxbryta label listed headache, diarrhea, abdominal pain, rash, nausea and fever as the most common side effects.

Oxbryta lawsuits seek compensation from manufacturer Pfizer and its subsidiary Global Blood Therapeutics, which Pfizer acquired in 2022. The lawsuits claim that the companies acted improperly while creating and selling Oxbryta. This includes how the drug was developed, tested, labeled, marketed and distributed.

People filing Oxbryta lawsuits want compensation to cover past, present and future losses, with the amounts to be determined at trial. They also seek money for damages related to lost earnings and other financial issues. In addition, the lawsuits ask for punitive damages — intended to punish the manufacturers — and reimbursement for case-related costs and attorney’s fees.

As of March 2025, Oxbryta lawsuits are still in the early stages. There have been no trials, verdicts or publicly announced settlements. Lawyers have accepted and filed lawsuits in state and federal courts for clients from various states, including Illinois and California.

It’s unclear how widely used Oxbryta was while the drug was on the market from 2019 to 2024. However, it was the first medicine to target the cause of sickle cell disease — which affects roughly 8 million people — so it’s likely many people may have used it. Therefore, there is potential for a large number of lawsuits.

Because attorneys are filing these initial lawsuits in both state and federal courts, the Judicial Panel on Multidistrict Litigation could eventually combine these actions into multidistrict litigation if there are many lawsuits.

If a loved one passed away or you’ve experienced serious health problems — such as VOCs worsening or happening more often after taking Oxbryta — you might be eligible to file an Oxbryta lawsuit.

To qualify, you need proof that you have sickle cell disease and that doctors prescribed Oxbryta to you. You’ll also need to show evidence that your health has worsened or that you developed new health issues after starting Oxbryta.

How to File an Oxbryta Lawsuit and What to Expect

If you have suffered injuries after taking Oxbryta, you should talk to an experienced attorney who specializes in prescription drug lawsuits. These cases are complicated and involve large pharmaceutical companies with their own lawyers.

Remember that you have limited time to file an Oxbryta lawsuit. This is due to the statute of limitations, which varies by state. In some states, it may be as little as one year from the time of your injury.

Editor Lindsay Donaldson contributed to this article.