Voluntary market withdrawal: Oxbryta (Pfizer – October)

Pfizer Inc. is withdrawing Oxybryta from the market. Oxbryta is used for the treatment of sickle cell disease in adults and children 12 years old and older. Sickle cell disease affects the shape of red blood cells, which carry oxygen to all parts of the body.

This drug is being withdrawn from the market because recent data show the benefit of taking Oxbryta does not outweigh the risks. In clinical trials, there was a larger number of patients with severe pain because of less blood flow.

The Food and Drug Administration (FDA) has been conducting a safety review of Oxybryta and will communicate any additional findings when the review is complete. The FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of Oxbryta.

There are other FDA-approved medications for the treatment of sickle cell disease. The FDA advises that you should contact your doctor or health care professional about stopping Oxbryta and starting another treatment option.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Visit the FDA website.