A descriptive analysis of postmarketing requirement studies and clinical trials.

Purpose: Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has the authority to require applicants to conduct postmarketing studies or clinical trials. These postmarketing requirements (PMRs) provide additional data on the safety of the drug product. The purpose of the study was to conduct a descriptive analysis of FDAAA PMRs and the resulting regulatory actions.

Information Visualization Platform for Postmarket Surveillance Decision Support.

Introduction: The US FDA receives more than 2 million postmarket reports each year. Safety Evaluators (SEs) review these reports, as well as external information, to identify potential safety signals. With the increasing number of reports and the size of external information, more efficient solutions for data integration and decision making are needed.

Nucleoside analogues and mitochondrial toxicity.

An evaluation of the US Food and Drug Administration's Adverse Event Reporting System identified that patients coinfected with human immunodeficiency virus and chronic hepatitis C virus who were treated with a regimen of ribavirin and didanosine, with or without stavudine, were at increased risk for events associated with mitochondrial toxicity, including fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis. In response, the US product labels for didanosine and ribavirin have been revised to caution clinicians against coadministration of these drugs.

Increased US prescription trends associated with the CDC Bacillus anthracis antimicrobial postexposure prophylaxis campaign.

Purpose: We evaluated national outpatient antimicrobial prescription trends in relation to the first United States case of inhalational anthrax due to the intentional delivery of Bacillus anthracis (B. anthracis) spores.

Methods: We queried IMS HEALTH's National Prescription Audit Plus7 database for two 6-month periods (July-December) in 2001 and 2000 to describe outpatient prescription trends of antimicrobials recommended during the Centers for Disease Control and Prevention's (CDC) postexposure prophylaxis campaign.