Acute acalculous cholecystitis (AAC) is a rare but potentially life-threatening adverse effect linked to treatment with Lemtrada (alemtuzumab) in patients with relapsing-remitting multiple sclerosis (RRMS), according to a U.S. Food and Drug Administration review.
The study, “Acute acalculous cholecystitis — A new safety risk for patients with MS treated with alemtuzumab,” was published in the journal Neurology.
AAC is a disease affecting the gallbladder characterized by inflammation, which may lead to tissue death.
Initial product labeling for Sanofi Genzyme’s Lemtrada didn’t include AAC because of the low number of cases observed during clinical trials testing the therapy.
Based on a small case series of AAC associated with Lemtrada use in RRMS patients, the FDA’s Division of Pharmacovigilance conducted a review to evaluate AAC as a potential safety risk for patients taking the therapy.
Researchers searched the FDA Adverse Event Reporting System (FAERS) and medical literature for AAC cases associated