Oxbryta Lawsuit

On September 25, 2024, pharmaceutical company Pfizer announced it was withdrawing sickle-cell disease medication Oxbryta (voxelotor) from the global market.

This was in response to data from two postmarketing clinical trials on the drug that showed concerning results. Those taking Oxbryta experienced an increased risk of vaso-occlusive crises (blocked blood flow) and death from stroke.

Chaffin Luhana defective product attorneys are currently investigating cases in which patients took Oxbryta and then suffered from serious injuries and/or death. If you or a loved one has been affected by the potentially severe side effects of Oxbryta, we’d be happy to discuss your case with you.

What is Sickle Cell Disease?

Sickle cell disease—also called sickle cell anemia—is a genetic blood disorder characterized by the production of abnormal hemoglobin, known as hemoglobin S. Hemoglobin is the major protein that carries oxygen in red blood cells. When someone has sickle cell disease (SCD), they have a gene mutation that affects the hemoglobin molecule.

Usually, red blood cells look like discs and are flexible so they can easily move through the blood vessels. Abnormal hemoglobin (hemoglobin S) can cause red blood cells to become rigid and take on a crescent or “sickle” shape. They don’t bend or move easily, which means they can block blood flow to the rest of the body.

They also break down and die more quickly than regular red blood cells, which leads to lower numbers of red blood cells and less working hemoglobin to carry oxygen around the body. This can cause a myriad of symptoms and problems.

Key features of sickle cell disease include:

• Pain crisis: Blocked blood flow can cause sudden episodes or extreme pain, often in the chest, abdomen, or joints.
• Anemia: A condition when there are not enough healthy blood cells or hemoglobin to carry oxygen to the body’s tissues. Symptoms include fatigue, weakness, and shortness of breath. In a person with SCD, anemia results from the rapid breakdown of sickle cells, which have a shorter lifespan than normal red blood cells.
• Increased infection risk: SCD can damage the spleen—an organ that helps fight infections. This can increase a patient’s risk of developing bacterial infections.
• Organ damage: Over time, reduced blood flow can damage organs, including the liver, kidneys, and lungs.

There is no cure for SCD, and it can be difficult for doctors to manage the symptoms because treatment options are limited. When Oxbryta first came onto the market, it was thought to be a great breakthrough as it was the first drug approved to treat the root cause of the disease.

What is Oxbryta?

The U.S. Food and Drug Administration (FDA) approved Oxbryta on November 25, 2019. At that time, the drug was approved for adults and pediatric patients 12 years and older with sickle cell disease.

In 2021, the FDA approved Oxbryta to treat SCD in children aged four up to 11, meaning that anyone aged four and over could be prescribed the drug to treat the disease. On February 14, 2022, the European Union also approved Oxbryta.

Oxbryta works by helping to decrease the “sickling” of red blood cells, increasing normal hemoglobin levels and reducing the excessive breakdown of red blood cells. As a result, there are more healthy cells that carry oxygen around the body.

Oxbryta is available only by prescription as tablets. The usual recommended dose is 1,500 mg taken once daily.

Why Was Oxbryta Approved?

The FDA’s initial approval in 2019 was based on a clinical trial of about 274 patients aged 12 to 64. Some received Oxbryta and some a placebo. The results showed that the drug helped increase the amount of normal hemoglobin in the blood, reducing symptoms of SCD.

The FDA allowed Oxbryta manufacturer Pfizer to go through the “accelerated approval” program because, at the time, there were few treatment options for people with SCD, and new treatments were desperately needed. They did require, however, that Pfizer continue to perform clinical trials on the drug after releasing it on the market (e.g., “post-marketing trials”) to continue to examine its safety profiles.

The second approval for children was based on a phase 2 trial of 45 patients aged four to 11. Results showed again that the treatment helped increase the amount of hemoglobin in the red blood cells.

As with any medication, there were potential side effects with Oxbryta.  Labeling for Oxbryta reports the potential for headache, diarrhea, and abdominal pain. The most serious side effects included headaches and allergic reactions. At the time of these approvals, however, there was no warning of any potential life-threatening effects.

What’s Wrong with Oxbryta?

According to Pfizer’s press release, the cumulative data shows that the overall benefit of Oxbryta no longer outweighs the risks in the sickle cell patient population.

“The data suggest an imbalance in vaso-occlusive crisis and fatal events which require further assessment,” the company stated.

Vaso-occlusive crises are among the most common complications of SCD. They occur when blood flow is blocked by sickled red blood cells, causing an area of the body to be deprived of oxygen and nutrients. This results in acute pain and can cause organ injury. It may also lead to further health complications like arthritis, kidney failure, and stroke.

In July 2024, the European Medicines Agency (EMA)—similar to the Food and Drug Administration (FDA) in the U.S.— initiated a review of Oxbryta because of two postmarketing clinical trials that raised alarms.

The first assessed the effect of the drug on 236 children from 2 to 15 years with SCD who were at a higher risk of stroke. The results showed 8 deaths in those patients taking Oxbryta, compared to two in those taking a placebo.

The second study evaluated the effect of the medication on leg ulcers in 88 patients from 12 years of age. Leg ulcers are a known complication of SCD. The results showed that eight deaths occurred.

When the EMA opened the investigation, it was unclear if Oxbryta caused any of the deaths. The investigation is ongoing, but the EMA later issued a follow-up notice where it recommended the suspension of the medication:

“EMA’s human medicines committee (CHMP) has recommended suspending marketing authorization for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a precaution while a review of emerging data is ongoing.”

When analyzing the two studies, the EMA discovered that the patients had a higher occurrence of vaso-occlusive crises (VOC) during treatment with Oxbryta than they did before starting the medication.

The CHMP noted that these data “raise serious concerns about the safety of Oxbryta…” They recommended that the medication be suspended until the conclusion of the investigation. This prompted Pfizer to recall the medication worldwide.

FDA Alerts Patients and Healthcare Professionals

On September 26, 2024, the U.S. Food and Drug Administration (FDA) alerted patients and healthcare providers about the voluntary withdrawal of Oxbryta. The administration told healthcare professionals to stop prescribing the medication and suggested patients and caregivers contact their doctors about stopping Oxbryta and starting another treatment option.

The FDA stated: “FDA has been conducting a safety review of the postmarketing clinical trial data for Oxbryta, the real-world registry studies, as well as postmarketing data from the FDA Adverse Event Reporting System (FAERS). At the conclusion of this safety review, FDA will communicate any additional findings, if necessary.”

In December 2023, the FDA approved two new gene therapy treatments for SCD, one by Vertex Pharmaceuticals and CRISPR Therapeutics, and the other by Lyfgenia. Both are approved for patients aged 12 and older.

Types of Personal Injuries Possible with Oxbryta

In addition to minor side effects, Oxbyrta may cause more serious side effects in some patients, however, including:

• Vaso-occlusive crises
• Acute pain
• Hospitalization
• Tissue and organ damage
• Arthritis
• Kidney failure
• Stroke
• Death

Patients taking Oxbryta are encouraged to talk to their healthcare providers about alternative treatments. They can also contact Pfizer at 1-800-438-1985. Pfizer stated it will “keep patients, regulator authorities, investigators and clinicians informed about actions and appropriate next steps for Oxbryta.”

Chaffin Luhana Investigating Cases of Injury and Death Related to Oxbryta

As patients become aware of the connection between Oxbryta and more serious side effects, they are likely to be understandably upset that they weren’t warned about the possibility of these effects before.

The Chaffin Luhana law firm is examining cases in which patients took Oxbryta and then suffered from serious side effects or death. We are also following the scientific investigation into the drug. Any potential liability issues could lead to a large number of lawsuits filed.

If you or a loved one was seriously injured and you believe Oxbryta was the cause, contact one of our personal injury lawyers today. We are passionate advocates for plaintiffs who were harmed by drugs that were supposed to be safe to use and stand ready to help you pursue compensation to the fullest extent allowed under the law.

Call us today at 888-480-1123.

Frequently Asked Questions

Can I file an Oxbryta lawsuit against Pfizer?

Patients who took Oxbryta and then suffered from serious side effects such as vaso-occlusive crises, organ damage, stroke, and death should talk to a personal injury attorney about potentially filing a lawsuit. Companies like Pfizer must ensure their medications are safe before distributing them to hundreds of thousands of patients.

Is there a recall on Oxbryta?

Manufacturer Pfizer issued a global recall of all lots of Oxbryta on September 25, 2024. The recall was prompted by two postmarketing clinical trials that showed that patients had a higher occurrence of vaso-occlusive crises and death when taking the medication.

Patients taking Oxbryta should talk to their doctors right away about other medication alternatives.

What is a vaso-occlusive crisis?

A vaso-occlusive crisis occurs when the blood flow is blocked to a certain part of the body. It is a common symptom of sickle cell disease, but in two recent clinical trials, was also found to happen more often in patients taking Oxbryta. When blood flow is blocked, a patient usually experiences acute pain. At the same time, a certain part of the body is left without oxygen or nutrients, which can cause tissue and organ damage or stroke.

Is Oxbryta FDA-Approved?

The FDA approved Oxbryta in 2019 for people aged 12 and older with sickle cell disease. The drug went through the FDA’s accelerated approval program, which offers a faster approval process for medications meant to treat serious diseases and that may fulfill an unmet medical need. At the time of the approval, Oxbryta was the first medication designed to treat the root cause of sickle cell disease.

Is Oxbryta Effective?

In the clinical trials used to gain FDA approval, Oxbryta was shown to help increase the number of healthy red blood cells in patients, thereby reducing symptoms of sickle cell disease. Postmarketing studies, however—which were undertaken after the drug received FDA approval—have raised concerns about serious and even deadly side effects.