Hemophagocytic lymphohistiocytosis associated with the use of lamotrigine.

Objective: To describe adverse event reports of hemophagocytic lymphohistiocytosis (HLH) reported in association with lamotrigine.

Methods: The Food and Drug Administration Adverse Event Reporting System database of spontaneous adverse event reports and medical literature databases were searched for cases of HLH reported in association with lamotrigine. Cases were included if they met the case definition of suspected or confirmed HLH and if causal association was assessed as robust or supportive.

Acute acalculous cholecystitis: A new safety risk for patients with MS treated with alemtuzumab.

Objective: To evaluate acute acalculous cholecystitis (AAC) as a potential safety risk for patients treated with alemtuzumab.

Methods: The Food and Drug Administration Adverse Event Reporting System and the medical literature were searched for cases of AAC in conjunction with alemtuzumab for all clinical indications.

Results: Eight spontaneously reported cases meeting the case definition of AAC in close temporal association with alemtuzumab use were identified.

Liver injury associated with dimethyl fumarate in multiple sclerosis patients.

Background: In pre-approval trials, there was an increased incidence of mild, transient elevations of liver aminotransferases in study subjects treated with dimethyl fumarate (DMF).

Objective/methods: To evaluate post-marketing cases of drug-induced liver injury associated with DMF.

Results: We identified 14 post-marketing cases of clinically significant liver injury.

Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.

Purpose: To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007-early 2008 during a national investigation of allergic-type events. The investigation identified Baxter Healthcare-brand heparin product due to its strongest association with the events.