Safety Events Common in Newly Approved Drugs

Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown.

Biologic and psychiatric drugs, as well as those that received accelerated approval or were approved within 60 days of the statutory decision deadline, are the most vulnerable to postmarket safety events, Nicholas S. Downing, MD, from the Department of Medicine at Brigham and Women's Hospital in Boston, Massachusetts, and colleagues report. Their study was published online May 9 in JAMA.

The findings "are not surprising to those of us who have been following this for a while, but they do reflect a growing realization by the mainstream medical community that there are important differences between efficacy in randomized controlled trials and effectiveness once a drug hits the real world," Peter J. Pitts told Medscape Medical News. Pitts is a former FDA associate commissioner and current president of the Center for Medicine in the Public Interest, New York, New York. "It reinforces the basic truth that when you give people medicine, interesting things will happen — good and bad. Postmarket research is the continual search for understanding what these interesting things are in the real world," he added.


 
Sign Up for Our Email Newsletter

RECENT NEWS

Streamline drug approval process

Streamline drug approval process

When Americans don't fill their prescriptions, their illnesses worsen, which drives up healthcare spending....  Read more

‘Transparency’ alone can’t convey the context or complexity of pricing drugs

‘Transparency’ alone can’t convey the context or complexity of pricing drugs

A key problem with Mr. Azar’s transparency effort is that it doesn’t provide consumers with any context or insights into ...  Read more

Safe Harbor Sunshine And Flat Fees: Vital Steps Towards Smarter Drug Spending

Safe Harbor Sunshine And Flat Fees: Vital Steps Towards Smarter Drug Spending

The current system encourages payers to favor medicines that carry higher rebates than lower list-priced drugs....  Read more

DRUGWONKS BLOG