Product Information:
Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies suggesting an unfavourable imbalance in the number of vaso-occlusive crises and fatal events in patients treated with Oxbryta.

Advice for healthcare professionals
Stop supplying the above product immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Physicians, specialist prescribers, homecare company providers or any other healthcare professional responsible for prescribing Oxbryta should contact all patients undergoing treatment and advise them to discontinue treatment and, where appropriate, discuss alternative treatment options. Patients should be instructed to return the product to the hospital pharmacy or homecare company that dispensed it.
Patients should continue to be monitored for adverse events after their treatment with Oxbryta is discontinued and ensure appropriate follow-up as needed. New patients should not start treatment with Oxbryta. More information can be found in the Direct Healthcare Professional Letter shared with this notification.

Click to view full text on MHRA website