Published in:
01-01-2020
Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling
Authors:
Bansri Desai, PharmD, Kyungwan Hong, PharmD, MS, John H. Powers III, MD, Peter Doshi, PhD
Published in:
Journal of General Internal Medicine
|
Issue 1/2020
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Excerpt
Obtaining an accurate understanding of the known benefits and risks of drugs is difficult, particularly when drugs first come to market. The most robust evidence is largely limited to pre-marketing studies (e.g., phase 3 trials), but the peer-reviewed literature describing these studies may be incomplete (e.g., with unpublished trials), and systematic reviews often have yet to be conducted. Despite their reputation as unhelpful, FDA-approved prescribing information (also known as “package inserts” or “drug labels”) should provide clinicians with a trustworthy source of information about new drugs that has been independently vetted. …
