Oxbryta Lawsuit | 2025 Latest Updates

Oxbryta Lawsuit Overview

Oxbryta (voxelotor) lawsuits are being filed after Pfizer’s voluntary recall of the sickle cell disease medication. The recall was prompted by studies showing an increased risk of vaso-occlusive crisis and death compared to alternative treatments. Originally approved by the FDA in 2019, Oxbryta was prescribed to adults and children 4 years and older to prevent red blood cells from becoming sickle-shaped [1].

Latest Oxbryta Lawsuit Updates

March 23, 2025 – Lawsuits have been filed by patients who suffered severe side effects, with claims focusing on the safety concerns surrounding Oxbryta’s use.

March 13, 2025 – Patients affected by Oxbryta’s dangerous side effects are exploring their legal options, with lawsuits already in progress to seek compensation for health damages.

March 1, 2025 – As Oxbryta faces growing lawsuits due to its adverse effects, patients and their families are seeking compensation for the harm caused by the medication.

January 16, 2025 – A wrongful death lawsuit has been filed against the manufacturers of Oxbryta, alleging that the drug was responsible for fatal outcomes in certain patients.

September 26, 2024 – The FDA issued a warning following Pfizer’s voluntary withdrawal of Oxbryta from the market, after postmarketing clinical trials and real-world registry studies identified higher rates of death and vaso-occlusive crises in patients taking the medication.

September 25, 2024 – Pfizer announced that “the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population,” based on data suggesting an imbalance in vaso-occlusive crises and fatal events.

FDA Reports and Statistics

According to the FDA’s September 26, 2024, warning:

• Postmarketing clinical trials revealed higher rates of vaso-occlusive crises and deaths in patients taking Oxbryta compared to placebo
• Two real-world registry studies confirmed increased rates of vaso-occlusive crises in patients taking Oxbryta
• The FDA is urging healthcare professionals to stop prescribing Oxbryta following its market withdrawal
• Patients are advised to contact their physicians about stopping Oxbryta and switching to alternative treatment options

Oxbryta Injuries & Side Effects

Oxbryta has been linked to several serious health complications that may qualify affected patients for legal action.

• Vaso-occlusive crisis (VOC): Severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues [2]
• Severe allergic reactions: Including rash, hives, and potentially life-threatening responses
• Death: Increased mortality risk compared to alternative treatments
• Additional side effects: Headache, diarrhea, abdominal pain, nausea, and fever

Do You Qualify for an Oxbryta Lawsuit?

You may qualify for an Oxbryta lawsuit if:

• You or a loved one were prescribed Oxbryta for sickle cell disease
• You experienced serious side effects including vaso-occlusive crisis, severe allergic reactions, or other significant complications
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to Oxbryta use

Evidence Required for an Oxbryta Lawsuit

To successfully pursue an Oxbryta lawsuit, you will need:

• Medical records showing Oxbryta prescription
• Documentation of side effects or complications experienced
• Medical records demonstrating treatments required for these complications
• Timeline connecting Oxbryta use to the onset of symptoms

Damages You Can Recover

Successful Oxbryta lawsuits may provide compensation for:

• Medical expenses related to treating complications
• Lost wages due to inability to work
• Pain and suffering caused by side effects
• Punitive damages against the manufacturer (in some cases)

Oxbryta Recall Information

• Recall date: September 25, 2024 (Pfizer announcement), with FDA warning issued September 26, 2024 [3]
• Products affected: All Oxbryta (voxelotor) formulations
• Recall reason: Higher rates of vaso-occlusive crises and deaths in patients taking Oxbryta compared to placebo in clinical trials and registry studies
• FDA action: Issued a warning to patients, caregivers, and healthcare providers to discontinue use of Oxbryta and seek alternative treatments

Statute of Limitations for Oxbryta Lawsuits

The time you have to file an Oxbryta lawsuit varies by state but typically ranges from 1-3 years from the date you discovered (or should have reasonably discovered) your injury was connected to Oxbryta use. Because of the recent recall in September 2024, many potential claimants still have time to file, but this window will begin closing in late 2025 in some jurisdictions.

FAQs

1. How do I know if my health problems are related to Oxbryta?

If you experienced vaso-occlusive crisis, severe pain, or other unusual symptoms while taking Oxbryta, consult with your healthcare provider. Medical tests and evaluations can help determine if there is a connection between your symptoms and the medication.

2. How much compensation could I receive from an Oxbryta lawsuit?

Compensation amounts vary based on factors including severity of injuries, medical costs incurred, lost income, and impact on quality of life. Some pharmaceutical lawsuits have resulted in settlements ranging from thousands to millions of dollars.

3. Can I join an Oxbryta class action lawsuit?

Currently, individual lawsuits are being evaluated, which may eventually be consolidated into multidistrict litigation (MDL). Our attorneys can advise whether an individual claim or participation in larger litigation is most appropriate for your situation.

4. How long will an Oxbryta lawsuit take?

The timeline varies depending on case complexity, evidence strength, and whether the case settles or goes to trial. Some pharmaceutical litigation resolves within 1-2 years, while complex cases may take longer.

5. What if my loved one died after taking Oxbryta?

Family members may be eligible to file a wrongful death lawsuit if a loved one passed away after taking Oxbryta. These cases can provide compensation for medical expenses, funeral costs, lost financial support, and emotional suffering.

6. Can I file a lawsuit if I’m still taking Oxbryta?

The FDA has recommended that all patients discontinue Oxbryta use immediately and consult with their healthcare providers about alternative treatments. You should follow medical advice regarding medication changes, but can still pursue legal action for injuries sustained.

7. What makes Oxbryta dangerous?

Clinical trials and real-world studies revealed that Oxbryta increases the risk of vaso-occlusive crisis and death compared to alternative sickle cell disease treatments, prompting Pfizer’s decision to withdraw the drug from the market.

8. Who is the manufacturer of Oxbryta?

Oxbryta is manufactured and marketed by Pfizer Inc., which voluntarily recalled the medication in September 2024 after safety concerns emerged.

See all related dangerous drug lawsuits our attorneys covered so far.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action related to Oxbryta injuries. Most states only allow 1-3 years from the discovery of your injury to file a lawsuit, and this window is already closing for some affected patients.

Schmidt & Clark, LLP firm offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for representation
• Payment only if we win your case or secure a settlement

Don’t delay in seeking the compensation you deserve for injuries caused by this dangerous medication.

[START YOUR FREE CASE REVIEW NOW]

References:

[1] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntarily-withdraws-all-lots-sickle-cell-disease 

[2] https://sicklecellanemianews.com/vaso-occlusive-crisis/ 

[3] https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerting-patients-and-health-care-professionals-about-voluntary-withdrawal-oxbryta-market-due#:~:text=%5B9%2F26%2F2024%5D,professionals%20should%20stop%20prescribing%20Oxbryta.