Unpredictable And Potentially Fatal Immune-Mediated Reactions Can Occur Within Months And Up To At Least 4 Years After Lemtrada Treatments
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has completed its review of Lemtrada (alemtuzumab) in the treatment of multiple sclerosis patients. Significant Lemtrada safety findings include the early risks of cardiovascular events with Lemtrada use and Lemtrada-related thrombocytopenia around the time of infusion, as well as long-delayed immune-mediated reactions involving Lemtrada years after its use.
The MHRA issued its review document, "Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions", on February 12, 2020. Here are its Lemtrada safety findings as regards the risks of cardiovascular events with Lemtrada use and immune-mediated reactions involving Lemtrada:
The review concluded that serious cardiovascular reactions can rarely occur within 1 to 3 days of [Lemtrada (alemtuzumab)] infusions in people without any identifiable risk factors. Reactions included myocardial ischaemia, cerebral haemorrhage, arterial dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage, and non-immune thrombocytopenia.
The review also found unpredictable and potentially fatal immune-mediated reactions can occur within months and up to at least 4 years after treatment with [Lemtrada (alemtuzumab)]. Reactions included autoimmune hepatitis, haemophagocytic lymphohistiocytosis, and acquired haemophilia A. The review also identified serious cases of Epstein-Barr virus reactivation reported after treatment, including hepatitis. Some patients developed more than one autoimmune disorder following treatment.
Lemtrada is a monoclonal antibody (mAb) authorized for the treatment of adults with relapsing-remitting multiple sclerosis.
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We have written several times previously about Lemtrada safety findings pointed out by the FDA and other drug regulatory agencies in the past couple of years:
- In December 2018 we published this article, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", which covered a November 2018 FDA Drug Safety Communication about Lemtrada.
- In July 2019 we published this article, "Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation", to inform the MHRA had established new use restrictions and requiring increased monitoring of patients using this Lemtrada.
- In October 2019 we published this article, "Lemtrada Adverse Events May Occur More Frequently Than Previously Noted By Drug Safety Regulators And Researchers", which pointed out a study that found six additional deaths related to Lemtrada use that had not been reported before.
Soon after that last article, a "Dear Healthcare Professional Letter" was sent out by sanofi-aventis Canada Inc., "LEMTRADA (alemtuzumab) - Risk of Autoimmune Hepatitis, Haemophagocytic Lymphohistiocytosis, and Associated Serious Cardiovascular Reactions".
We will continue to monitor the medical literature for reports of cardiovascular events with Lemtrada use and immune-mediated reactions involving Lemtrada.
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