The drug received approval from the U.S. Food and Drug Administration (FDA) through an accelerated process. It was developed by Global Blood Therapeutics, Inc., which Pfizer acquired in October 2022.
In September 2024, Pfizer issued a recall of Oxbryta following reports of multiple deaths and other life-threatening complications. Patients with sickle cell anemia experienced severe side effects, including vaso-occlusive crises (VOCs) and strokes. The recall stated that the number of adverse events reported outweighed the drug’s benefits, prompting the company to remove it from the market.
FDA Warning
September 26, 2024 the FDA issued a Patient Safety Alert to patients, caregivers, and health care professionals that Pfizer was voluntarily removing Oxbryta from the market due to safety concerns.
Voluntary Removal
September 25, 2024, Pfizer announces a voluntary recall of all lots of its sickle cell treatment drug, Oxbryta. The company noted is was discontinuing its clinical trials and notes that based on its own data the overall benefit no longer outweighs the risk.
MDL
No current MDL. Due to the recent nature of the recall a petition for an MDL has yet to be filed. It is anticipated that a motion will likely be filed within the first half of 2025.
Litigation Update
December 2024 a class action was filed in the Northern District of California. No multidistrict litigation has yet been sought due to the recent nature of the recall, but it is anticipated that a motion will be filed within the first half of 2025.
Important links
- 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.
- https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntarily-withdraws-all-lots-sickle-cell-disease
MDL link
No current MDL