Pfizer is withdrawing all sales of the sickle cell disease drug Oxbryta.
Patients have reported severe pain and even death associated with the drug’s use. Patients are being advised by Pfizer, the FDA and the European Medicines Agency to contact their prescribing physician if they are currently taking the drug. Oxbryta treats hemolytic anemia which can result from sickle cell disease.
Dangerous side effects were reported in two registry-based studies. This included an increased number of “vaso-occlusive crises.”
Symptoms of vaso-occlusive injuries include:
- Arthritis
- Kidney failure
- Stroke
- Death
The European Medicines Agency commenced a review of the Oxbryta in July 2024. The agency sought further study to see if patient deaths were related to Oxbryta’s side effects.
How Long Has Oxbryta Been Sold?
The FDA approved Oxbryta in 2019 for patients 12 and older. In 2021, the drug was approved for children from 4 to 11 years old. Also known by its chemical name “voxelotor,” the drug blocked the mutant hemoglobin that causes sickle cell disease.
Litigation For Recalled Drugs
Drug litigation goes by several names: mass tort litigation, drug product liability lawsuits, and class actions. Plaintiffs can file individual suits, which are evaluated based on their specific circumstances. While some side effects may be temporary and not lead to significant harm, others, especially those not adequately warned about, can worsen when doctors are unaware of the cause. Each patient’s injuries are thoroughly assessed in these claims, and settlement values depend on various factors. Investigations often focus on whether early clinical trials revealed these side effects and if healthcare providers and the FDA were fully informed. In the case of Oxbryta, a European medical agency notably raised concerns first.
If you or a loved one have been affected by severe side effects from Oxbryta, contact our Oxbryta lawyers at Rheingold Giuffra Ruffo Plotkin & Hellman LLP to help understand your rights and potential compensation.
David specializes in an active trial practice primarily involving drug products, medical device liability and product liability cases. On both a state and national level, he has obtained substantial client settlements through arbitration, mediation and direct negotiations with some of the largest national and international drug and medical device makers. David has been involved in multiple high-profile legal cases including the $2.5 billion DePuy ASR and DePuy Pinnacle metal-on-metal hip implant settlement plan and the $1.4 billion Stryker Rejuvenate metal-on-metal hip implant settlement plan.
