Medicine recalls
|
| |
| The United Kingdom: Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500mg Tablets (voxelotor) |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets (voxelotor) (batch number: 1941738, 1997214). Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies suggesting an unfavourable imbalance in the number of vaso-occlusive crises and fatal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.
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-limited-oxbryta-500mg-tablets-voxelotor-el-24-a-slash-44
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by European Medicines Agency and FDA, and was posted on the Drug Office website on 27 Sep 2024.
Ends/Wednesday, Oct 2, 2024
Issued at HKT 16:15
|
| |
|
