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Research Letter |

Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012

Christine M. Cheng, PharmD1,2; Jaekyu Shin, PharmD, MS2; B. Joseph Guglielmo, PharmD2
[+] Author Affiliations
1Disease Decision Support Group, First Databank Inc, San Francisco, California
2Department of Clinical Pharmacy, San Francisco School of Pharmacy, University of California, San Francisco
JAMA Intern Med. 2014;174(10):1704-1705. doi:10.1001/jamainternmed.2014.4854.
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Boxed warnings describe potentially life-threatening risks associated with certain prescription drugs.1 The warnings are surrounded by a border or “box” in the drug label and may be present at the time of drug approval (ie, a premarket warning) or added during the postmarket period (ie, a postmarket warning). Despite the use of boxed warnings for the most serious adverse reactions, trends and associated predictors for such warnings have not been well characterized. The objective of this study was to determine the frequency of premarket and postmarket boxed warnings and safety-related withdrawals for novel therapeutics approved between 1996 and 2012.

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Incidence of Postmarket Boxed Warnings or Withdrawals and Premarket Boxed Warnings

A, Incidence of postmarket boxed warnings or withdrawals issued by year (1996-2013). B, Incidence of premarket boxed warnings by approval year (1996-2012).

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