Many New Drugs Experience Postmarket Safety Issues

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.


Jonathan Block

Jonathan Block is a freelance writer and former MedShadow content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including BioCentury, The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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