Off-label Drug Use: Fact vs. Fiction

The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.   The article format addresses 10 common questions and their answers...

Drug Safety: Tip of the Iceberg

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim.  It is interesting...

New FDA Postmarketing Drug Safety Evaluation Website

As of 15 June 2010, the new Food and Drug Administration (FDA) Postmarketing Drug Safety Evaluation website was launched.   The FDA posted postmarket safety evaluations for 26 drugs approved between September 2007 and January 2008 and is reviewing an additional 20 or...

Drug Safety: Current overview of FDA postmarket surveillance

How can we better execute postmarket drug surveillance?  A recent study proposes formation of a detailed, publicly available database that could be continually updated and aggregated with new information as new clinical study results are published.  This essentially...