Other safety alerts
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| The United States: FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns |
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The United States Food and Drug Administration (FDA) announces that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns. Health care professionals should stop prescribing Oxbryta. Patients and caregivers should contact their health care professional about stopping Oxbryta and starting another treatment option.
Pfizer Inc., the manufacturer of Oxbryta, announced it is voluntarily withdrawing the medication from the market, ceasing distribution, and discontinuing all active clinical trials and expanded access programs for Oxbryta because recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.
In postmarketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease receiving Oxbryta compared to placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these postmarketing studies. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies. Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk.
FDA has been conducting a safety review of the postmarketing clinical trial data for Oxbryta, the real-world registry studies, as well as postmarketing data from the FDA Adverse Event Reporting System. At the conclusion of this safety review, FDA will communicate any additional findings, if necessary. There are other FDA-approved medications for the treatment of sickle cell disease, which health care professionals may prescribe as an alternative treatment to Oxbryta.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerting-patients-and-health-care-professionals-about-voluntary-withdrawal-oxbryta-market-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Sep 27, 2024
Issued at HKT 16:30
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