Lawsuit Indicates Oxbryta Side Effects Put Child in ICU

Teen boy nearly died multiple times in critical care and ICU due to vaso-occlusive crises caused by Oxbryta, requiring oxycodone and morphine to ease the pain.

Just over a year ago, Pfizer recalled the sickle cell drug Oxbryta from the market, after reports indicated that the treatment may be causing vaso-occlusive crises (VOCs), rather than preventing the complications like it was intended to. However, a Pennsylvania family indicates that the decision came too late for their child.

Oxbryta (voxelotor) was approved for the treatment of sickle cell disease by the U.S. Food and Drug Administration (FDA) in 2019, as the first drug approved to treat the root cause of the condition, by improving hemoglobin levels in the body and helping the blood cells hold on to more oxygen. The drug was developed by Global Blood Therapeutics, which was acquired by Pfizer in 2022.

Sickle cell disease, also called sickle cell anemia, is a lifelong inherited blood disorder that affects the protein in the blood and causes the blood cells to break down and die from a lack of oxygen. It is a serious condition, which can cause blood flow blockage, infections, pain and fatigue.

Oxbryta Side Effects

When Pfizer issued its Oxbryta recall on September 25, 2024, the manufacturer indicated that the risks of Oxbryta side effects appear to outweigh the drug’s benefits, concluding there were too many VOCs, and even fatal events, linked to the drug.

According to a complaint (PDF) filed against Pfizer and its Global Blood Therapeutics Inc. subsidiary, one of those patients who experienced those complications was a 13-year-old Pennsylvania boy, identified in the lawsuit only as Z.C. The claim was filed by a parent, identified only as W.W., in the U.S. District Court for the Western District of Pennsylvania on October 1.

It joins a growing number of Oxbryta lawsuits now being pursued by former users of the drug, who say they suffered severe VOC side effects, or lost loved ones, because the medication was not properly researched before being placed on the market.

The complaint indicates Z.C. was diagnosed with sickle cell disease (SCD) as a child. He took part in an Oxbryta safety study in 2021, and then began using it regularly when it came onto the market.

Problems began in 2022, when Z.C. began experiencing a significantly higher number of VOC events and other side effects. These led to severe pain, swelling and other complications by 2023, according to the complaint.

The boy was prescribed oxycodone and morphine to deal with the intense pain. Unable to discover the root cause of the problem, doctors began giving regular blood transfusions, although they still could not solve the initial concern.

Z.C. was placed in critical care and the intensive care unit (ICU) on several occasions and almost died multiple times, the lawsuit indicates.

According to the complaint, none of the doctors knew what the problem was, because the drug’s manufacturers did not provide a warning on the label, and as illustrated by its eventual Oxbryta recall, failed to adequately test the drug before putting it into circulation.

“Defendants failed to adequately test Oxbryta to investigate the risks, including the potential of decreased delivery of oxygen and increased VOCs, and the clinical benefits, if any, of the drug. Defendants’ trials have been small in size and limited in duration of follow-up.”

– W.W. v. Global Blood Therapeutics, Inc. and Pfizer, Inc.

Z.C.’s mother presents claims of design defect, failure to warn, negligence, negligent misrepresentation, breach of warranties, quasi-contract/unjust enrichment, and seeks compensatory damages for past and future medical expenses.

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