Safety Events Common in Newly Approved Drugs

N/A by N/A is licensed under N/A N/A
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.


 
Article Photo Credit: N/A by N/A is licensed under N/A N/A
Sign Up for Our Email Newsletter

RECENT NEWS

Vaper Madness

Vaper Madness

E-cigarettes, while not a cure for nicotine dependence, can help reduce the death and disease caused by combustible tobac...  Read more

Three ways Congress can lower seniors’ pharmacy bills

Three ways Congress can lower seniors’ pharmacy bills

Here are three ways Congress can improve Medicare Part D to lower seniors’ drug tabs....  Read more

FDA Hears Concerns About The Unregulated CBD Market

FDA Hears Concerns About The Unregulated CBD Market

What most speakers agreed on: the need for federal CBD oversight for production quality, more testing and research and be...  Read more

DRUGWONKS BLOG