An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance.

Introduction: The most commonly reported adverse event, based on frequency of Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), in the US FDA Adverse Event Reporting System (FAERS) database is "drug ineffective" (DI). This study aimed to describe the DI reports and provide data to support recommendations on how to best evaluate these reports.

Methods: We characterized all FAERS reports coded with the MedDRA PT "drug ineffective" received between 1 September 2012 and 31 August 2016 using all other FAERS reports as a comparator.

Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.

Purpose: To evaluate the safety-related regulatory actions implemented by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2012.

Methods: We analyzed serious safety issues appended to drug package inserts (PIs) in Japan in 2012. The issues were characterized according to drug class, adverse event, years since drug approval, initiator of regulatory actions, revised section of PI, and evidence source.

Regulation of the statements in the information on drug metabolizing enzyme in the package insert--the present regulation and its history in Japan, the U.S. and the U.K.

The information about a drug interaction is specified as a section which should be printed on the package insert in Japan, the U.S. and the U.