Oxbryta

Oxbryta Recall and Defective Drug Litigation

Oxbryta: What is the Drug and How is it Used

Oxbryta, the brand name for voxelotor, is a medication made by Pfizer for sickle cell disease (SCD). Approved by the FDA in 2019, Oxbryta was called a game changer for patients with this chronic inherited blood disorder. SCD affects millions worldwide, and mostly those of African descent as well as those of Hispanic, Middle Eastern, and South Asian descent. The condition is characterized by abnormally shaped red blood cells that can block blood flow and cause pain and organ damage.

Oxbryta works by inhibiting hemoglobin polymerization — the process that causes the sickle shape of red blood cells. The idea is to keep the cells rounder and more flexible so they can flow better in the bloodstream and deliver more oxygen and reduce the risk of vaso-occlusive crises (VOCs). It was approved for patients 12 and older as a daily oral medication.

But despite its promise to alleviate the severe symptoms of SCD Oxbryta was linked to serious side effects and was recalled by the FDA in September 2024.

Oxbryta Recall and Why

September 26, 2024 the FDA recalled Oxbryta because of a significantly increased risk of life-threatening complications. Specifically, patients were at increased risk of vaso-occlusive crises (VOCs) and in some cases death. This recall was issued after reports and evidence of complications surfaced and it was clear the risks of Oxbryta outweighed the benefits for some patients.

The recall of Oxbryta was a public health safety measure because VOCs are so serious in patients already vulnerable with sickle cell disease. Patients, caregivers, and healthcare professionals were instructed to stop the use of Oxbryta immediately and find alternative treatments as the drug could exacerbate or trigger serious complications in those using it.

This recall has left many patients looking for alternative treatments and wondering how the drug was approved and monitored post approval. For those who have been harmed or lost loved ones because of Oxbryta legal recourse may be the way to get justice and compensation for their injuries.

What are Vaso-Occlusive Crises? What are the Complications?

A vaso-occlusive crisis (VOC) is one of the complications of sickle cell disease. A VOC occurs when the abnormally shaped red blood cells which are sickle or crescent-shaped block small blood vessels and impede normal blood flow. When these cells block the circulation oxygen delivery to the tissues is severely compromised and ischemia (a restriction of blood supply) occurs and pain episodes happen. These pain crises can range from mild to severe and debilitating and require hospitalization and strong pain management.

Symptoms of Vaso-Occlusive Crises

The main symptom of VOCs is pain which can occur anywhere in the body but often affects the chest, back, arms, and legs. The frequency, duration, and intensity of these pain episodes vary from patient to patient. Some other symptoms and complications of VOCs may include:

• Swelling and Inflammation: Because of impaired blood flow and subsequent tissue damage areas affected by VOCs become swollen, tender, and inflamed.
• Fever and Infection: When blood flow is blocked and tissues are oxygen starved the immune system is compromised and infection and high fevers occur.
• Organ Damage: Repeated VOCs can cause cumulative damage to organs such as the spleen, liver, kidneys, and heart. Over time this organ damage can be permanent and significantly impact a patient’s quality of life and life expectancy.
• Acute Chest Syndrome: VOCs that occur in the lungs can cause acute chest syndrome a life threatening condition characterized by chest pain, fever, shortness of breath, and lung inflammation. This requires immediate medical attention and can lead to respiratory failure if untreated.
• Increased Risk of Stroke: When VOCs affect the brain they can increase the risk of stroke, especially in children and young adults with sickle cell disease. Stroke can cause long-term neurological damage, cognitive impairments, and even death.

VOCs require hospitalization where patients receive aggressive pain management, IV fluids, and other supportive care to manage the complications. Unfortunately, VOCs are not only painful and debilitating but can also impact the life expectancy and quality of life of individuals with sickle cell disease.

Harm caused by Oxbryta on VOCs

The very nature of sickle cell disease makes patients prone to VOCs and Oxbryta was supposed to reduce them. But emerging evidence suggests that the drug instead of providing relief was increasing the frequency and severity of these crises in some patients. The mechanism behind this increased risk is still unknown but the FDA recall highlights the need to stop the drug to prevent further harm.

Patients who experienced an increase in VOCs on Oxbryta were faced with more severe pain episodes, more emergency visits, and further risk of complications like acute chest syndrome and organ damage. For families affected by these side effects the recall brings relief and anxiety: relief that the drug is no longer being used but anxiety about the long-term damage that has already been done.

Who is affected by the Oxbryta recall?

The Oxbryta recall affects individuals with sickle cell disease who were on the drug as part of their treatment. Sickle cell disease is a genetic condition that affects certain populations disproportionately, mainly those of African descent. It also affects Hispanic, Middle Eastern, and South Asian populations but to a lesser extent. Since Oxbryta was prescribed for chronic pain and complications of SCD, those most affected by the recall are:

1. SCD Patients Aged 12 and Older: Since Oxbryta was approved for patients 12 and up, this group represents the majority of those affected. Many of these patients turned to Oxbryta to reduce their VOCs and improve their quality of life.
2. Parents and Caregivers of SCD Patients: Families of children and young adults with SCD often play a big role in managing the disease and making treatment decisions. The Oxbryta recall affects these caregivers who may have seen their loved ones suffer more due to the drug’s side effects.
3. Healthcare Providers Treating SCD: Physicians, hematologists and other healthcare professionals who prescribed Oxbryta or managed patients on the drug may now need to find alternative treatments and help their patients navigate the recall.

Get Legal Help: Our Firm’s National Representation

If you or a loved one took Oxbryta and experienced an increase in vaso-occlusive crises, more pain episodes, or other serious side effects of the drug, you may have legal options. As a national law firm that handles defective drug cases, we are committed to help consumers get justice and compensation for their injuries.

What Are My Legal Options?

Patients harmed by Oxbryta may have a case against the drug’s manufacturer for negligence, defective design, failure to warn, and other claims. These cases will hold Pfizer accountable for the harm caused by the drug and get you compensation for medical bills, pain and suffering, lost wages, and other damages resulting from the side effects of the drug.

By filing a lawsuit victims and their families may recover:

• Medical Bills: Hospitalization, treatment for VOCs, and other medical care related to Oxbryta side effects.
• Pain and Suffering: Compensation for physical pain, emotional distress, and diminished quality of life due to an increase in VOCs and other side effects.
• Lost Wages and Income: Recovery of lost earnings due to time off work for medical treatment or unable to work due to health complications.
• Wrongful Death: For families who lost a loved one due to Oxbryta side effects, wrongful death claims can get compensation for funeral expenses, loss of companionship, and other related damages.

Why Choose Our Firm for Your Oxbryta Case?

We understand the special challenges patients and families with sickle cell disease face and the impact defective drug side effects can have on their lives. With a long history of pharmaceutical litigation, our firm is here to provide compassionate and knowledgeable legal help to those affected by the Oxbryta recall.

• National Representation: No matter where you are located, our team can handle Oxbryta cases nationwide, giving you the personal attention and dedication you need to navigate complex litigation.
• Experience in Defective Drug Cases: We have represented clients in many defective drug cases, and we know the medical science and legal strategy to build a strong case.
• No Fees Unless We Win: We work on a contingency fee basis, so you will not pay any attorney fees unless we get you compensation.

Contact the Law Office of Paul Mankin, APC if you believe that you have been injured due to taking the drug Oxbryta. 1-800-219-3577.