Oxbryta^® Lawsuits

At Trustwell Law, our experienced attorneys take a personalized, compassionate approach. We cut through the legalese and partner with our clients. We also have access to the expertise, resources, and manpower to fully investigate each case and fight for and with our clients to get the justice they deserve.

The FDA Announces Oxbryta Drug Recall

On September 26, 2024, the U.S. Food and Drug Administration (FDA) announced that Pfizer, Inc., the manufacturer of Oxbryta, issued a voluntary recall of the drug due to safety concerns. Oxbryta had been approved by the FDA through an expedited process in 2019 for adults and children age 12 years and older with sickle cell disease (also known as sickle cell anemia). In 2021, FDA granted accelerated approval for patients 4 to 11 years old. FDA accelerated, or expedited, approval is granted when surrogate or intermediate clinical studies indicate clinical benefit for drugs that treat serious conditions and fill an unmet clinical need. The FDA generally requires postmarketing studies to verify and describe the clinical benefits of medications approved under the accelerated approval program.

Oxbryta lawsuits will be based on the belief that Pfizer recalled the drug because it is defective and that Pfizer rushed Oxbryta through the approval process to begin selling it without adequate study and research.

Increased Risk of Vaso-Occlusion and Death from Oxbryta

Pfizer’s aftermarket research showed a higher rate of vaso-occlusion crisis events and more deaths among patients taking Oxbryta than those taking a placebo. Patients currently taking Oxbryta should contact their physicians immediately.

The primary symptom of vaso-occlusion crisis is moderate to severe pain that varies in frequency and intensity. The pain can be anywhere but often is in the arms, legs, back, and chest. Young children may also have swelling in their hands and feet. Vaso-occlusion crisis events may also be accompanied by a fever. Vaso-occlusion crisis events, also called pain crisis and sickle cell crisis, occur because of blocked blood flow and often require medical attention.

Sickle Cell Disease

Sickle cell disease, or sickle cell anemia, is a group of inherited blood 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 can move easily through the blood vessels. But in people with sickle cell disease, red bloods cells are misshaped, usually as a crescent, or sickle, shape. These crescent-shaped cells do not move as easily through the blood vessels and can block blood flow to the rest of the body.

Sickle cell anemia affects more than 100,000 people in the United States and 8 million people worldwide. With appropriate treatment, many people with sickle cell disease live fulfilling lives and safely participate in most activities. In the U.S., 9 out of 10 people who have sickle cell disease are of African ancestry or identify as Black.

Oxbryta Lawyers

If you took Oxbryta to treat the sickle cell disease and experienced an increase in vaso-occlusion crisis events or suffered the death of a loved one taking Oxbryta and are considering a Oxbryta lawsuit, contact us. You may be entitled to compensation.

The consultation is free, and if we take your case, you pay us nothing unless you receive compensation.