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Medicines regulation and law

EMA launches 'urgent safety review' of alemtuzumab after two patient deaths

The European Medicines Agency (EMA) has launched a safety review of alemtuzumab following reports of two deaths and several other cases of people experiencing life-threatening reactions shortly after taking the medicine.

In a drug safety update published on 17 May 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) warned that several patients had experienced immune-mediated and cardiovascular reactions within three days of taking Lemtrada, the brand name for the multiple sclerosis (MS) drug alemtuzumab.

The reactions led to 2 deaths from autoimmune hepatitis, as well as 34 cardiovascular reactions.

According to the MHRA, these included ten cases of myocardial infarction within 48 hours of their most recent alemtuzumab infusion, five of whom “did not have any risk factors”. A further 13 patients also experienced stroke within a day of their most recent treatment.

As a result, the EMA launched an “urgent safety review” of the medicine in April 2019, during which prescribers have been told to only start new patients on alemtuzumab if they have “relapsing-remitting MS that is highly active despite an adequate course of treatment with at least two other disease-modifying therapies” or if all other therapies are “otherwise unsuitable”.

Healthcare professionals have also been asked to closely monitor patients’ vital signs and liver function.

According to the MHRA, more than 34,000 people with MS have been treated with alemtuzumab worldwide in clinical trials and post-marketing in clinical practice.

Alemtuzumab was first approved in the EU for multiple sclerosis in 2013.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206568

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