The FDA announces the recall of Pfizer's rapidly developed sickle cell drug

Pfizer is voluntarily withdrawing a drug for sickle cell anemia from the global market, citing safety concerns. The recall, which is effective immediately, was announced on Thursday by the US Food and Drug Administration (FDA).

The FDA's approval of Oxbryta was accelerated in 2019, driven by positive hemoglobin levels in sickle cell patients compared to a placebo. Europe followed in 2022 based on the same evidence. Because there are now concerns that the drug could increase the risk of death, Pfizer is removing it from pharmacy shelves as a precaution.

“In post-marketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crises (severe pain caused by sickle cell disease that blocks blood flow and oxygen delivery to tissues) in patients with sickle cell disease who received Oxbryta compared to Placebo. ” The opinion from the FDA said. “In these post-marketing studies, there were also more deaths in the Oxbryta treatment group than in the placebo group.”

Pfizer confirmed that the decision to recall the drug was made only because the benefits may no longer outweigh the risks. Research on Oxbryta is ongoing and more studies are needed before it can be safely prescribed for sickle cell anemia.

The drug was prescribed to both adults and children.