Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500mg Tablets (voxelotor), EL(24)A/44

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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.

DMRC/MDR Number: DMRC-32749585

Company name: Pfizer Limited

Product description: Oxbryta 500 mg Tablets PLGB 00057/1720 SNOMED Code 41075911000001100

Details of the affected batches: 

Brief description of problem:

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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies suggesting an unfavourable imbalance in the number of vaso-occlusive crises and fatal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.

Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide and treatment is only initiated by physicians/specialist prescribers experienced in the management of SCD. The information in this recall reinforces action already being undertaken by Pfizer Limited and ensures that healthcare professionals in NHS Trusts and other care settings take appropriate action to recall all batches from patients as soon as possible. The recall notification is being shared with all healthcare professionals in the event that any patients experience any adverse events and require appropriate medical attention.

Advice to 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.

Advice to Patients:

Pfizer Limited has informed the MHRA that all batches of Oxbryta 500 mg Tablets are being withdrawn due to emerging data from clinical trials and registry-based studies that now indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. The data suggest an unfavourable imbalance in vaso-occlusive crises (acute painful crises) and fatal events (deaths).

Your healthcare professional responsible for your care and treatment will contact you to advise you or the child under your care being treated to stop taking Oxbryta 500 mg Tablets, and where appropriate, discuss alternative treatment options. They will also advise how to return any remaining packs of Oxbryta 500mg Tablets that you have in your possession. If you have not already been contacted by your healthcare professional, please contact them.

If you experience adverse reactions, have a sudden worsening of clinical condition, or have any questions about your medication, you should seek medical attention. If you have any concerns about your health or the health of somebody else, consult with your healthcare professional. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information enquiries please contact Pfizer Medical Information at https://www.pfizermedicalinformation.co.uk or telephone 01304 616161

To access the full recall and direct HCP letter: 

Class 2 Medicines Recall Pfizer Limited, Oxbryta 500mg Tablets (voxelotor)

Pfizer Limited, Oxbrtya Tablets, Direct Healthcare Professional Letter (DHPC)