Scientific Publications by FDA Staff

Hosp Pharm 2016 Sep;51(8):688-91

Summaries of safety labeling changes approved by the FDA: boxed warnings highlights.

Klafehn CW

As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. There were 10 revised boxed warnings and 1 drug class change from April through June 2016.