Action Due To Reports Of Lemtrada Side Effects Including Deaths Related To Immune Complications And Heart Or Circulatory Disorders
In late October 2019 the Pharmacovigilance Risk Assessment Committee (PRAC) -- a part of the European Medicines Agency (EMA) -- issued its final Lemtrada drug safety recommendations for use in relapsing-remitting multiple sclerosis (RRMS). The bottom line is PRAC advises that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada.
For the details, we look to this November 5, 2019 Multiple Sclerosis News Today report, "EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs":
Specifically, reports of fatalities and severe effects were associated with immune complications that included autoimmune hepatitis (immune-caused liver damage) and hemophagocytic lymphohistiocytosis (a disorder that may affect several organs in the body), and hemolytic anemia (abnormal red cell breakdown). Some immune reactions could happen “many months” after treatment with Lemtrada, PRAC noted.
Reports also surfaced of severe and deadly heart, circulation, and bleeding disorders, including heart attack, stroke, bleeding in the lungs, and cervicocephalic arterial dissection (tears in the arteries from the head and neck). These adverse events, PRAC said, could develop within days of Lemtrada’s use.
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From the first part of an EMA document titled "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019", here is a summary of the PRAC Lemtrada restrictions proposal:
EMA’s safety committee (PRAC) recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage.
We have written about Lemtrada safety issues three times previously over the past twelve months:
- "Lemtrada Adverse Events May Occur More Frequently Than Previously Noted By Drug Safety Regulators And Researchers" (October 9, 2019)
- "Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation" (July 3, 2019)
- "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label" (December 4, 2018)
We will watch for more Lemtrada drug safety developments in the medical and regulatory realms while we continue to investigate possible drug injury cases for patients seeking legal compensation for serious side effects.
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