“Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg tablets” due to concerns raised by “emerging data from clinical trials and registry-based studies”, the medicines regulator yesterday (September 30) announced.
The new data suggests “an unfavourable imbalance in the number of vaso-occlusive crises” – “acute painful crises” – “and fatal events in patients treated with Oxbryta”, the Medicines and Healthcare products Regulatory Agency (MHRA) said.
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The drug is used “for the treatment of haemolytic anaemia due to sickle cell disease (SCD)” and is “only initiated by physicians/specialist prescribers experienced in the management of SCD”, it added.
“The information in this recall reinforces action already being undertaken by Pfizer Limited,” the MHRA said.
“Quarantine all stock”
“Stop supplying the above product immediately”, the regulator stressed to healthcare professionals.
It added that they should “quarantine all remaining stock” and return it to their supplier using approved processes.
And it instructed all “physicians, specialist prescribers, homecare company providers or any other healthcare professional” prescribing Oxbryta to “contact all patients…and advise them to discontinue treatment”.
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“Patients should be instructed to return the product to the hospital pharmacy or homecare company that dispensed it,” it said.
In August, the MHRA warned that one ADHD drug was in short supply, while some period delay and opioid dependency drugs would remain “out of stock” into the autumn.
And in the same month, a manufacturer recalled a medicine used to treat multiple sclerosis (MS) “as a precautionary measure” due to unacceptable “variability”.
