Nearly one-third of new drugs approved by the FDA over a recent 10-year period were associated with a postmarket safety event.
Researchers examined the postmarketing history of 222 drugs and biologics approved by the FDA between 2001 and 2010. Of that number, 32% were the focus of a drug safety communication, boxed warning, withdrawal from the market, or a combination.
The study, published in JAMA, noted that the majority of pivotal trials used by drugmakers to secure FDA approval enroll less than 1,000 patients and have 6 months or less of follow-up, which can make it difficult to identify long-term adverse events or safety issues that may crop up.
The results showed that drugs used to treat mental illnesses and biologics, a newer class of medication often used to treat conditions such as autoimmune diseases and cancer, were most likely to have a drug safety issue. In addition, drugs that received accelerated approval — meaning a shorter review time because the medication meets an unmet medical need — were also linked to a higher chance of adverse events.
“Collaboration between the FDA and other stakeholders is necessary to develop and maintain an effective system for detecting postmarket safety events,” the researchers noted.