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.

Clinical profile of oxcarbazepine-related angioneurotic edema: case report and review.

Oxcarbazepine, a carbamazepine analog, was approved for use as an antiepileptic agent in the United States in 2000. A search of the United States Food and Drug Administration's Adverse Event Reporting System identified nine cases of oxcarbazepine-associated angioedema in pediatric patients aged 16 years and younger. We describe in detail the first U.

Improving the quality of adverse drug reaction reporting by 4th-year medical students.

Purpose: Evaluate whether a 15-minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms.

Methods: Seventy-eight 4th-year medical students were randomized to intervention 'Group-A' or non-intervention 'Group-B' on the first day of a required five-day clinical pharmacology rotation. Group-A participants attended a 15-minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting.