Researchers examined safety events of the 222 new therapeutics that received FDA approval between January 2001 and December 2010. A safety event was defined as a withdrawal due to safety concerns, FDA-issued boxed warnings and FDA-issued safety communications.
Of the 222 newly approved therapeutics, 71 were subject to a postmarket safety event, meaning 32 percent of novel therapeutics had a safety warning within 11.7 years of approval. The median time from approval to safety event was 4.2 years.
“Biologics, psychiatric therapeutics and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle,” the study’s authors concluded.
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