Understanding adverse effects will help you make a better-informed decision.
(Warning issued July 2018.)
(Warning issued May 2007.)
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What Does One Look Like?
The following excerpt from the prescription label of Zoloft is an example of a boxed warning.
Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Zoloft is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD).
In 2016, the FDA issued similar labeling guidance and warnings for immediate-release opioid medications.
In other words, opioids are dangerous drugs if not used judiciously under a physician’s close supervision.
These guides are meant to be given out by your pharmacist at the time you have your prescription filled.
The guides are also available online from the drug company and from the FDA.
2018;17(2):117123. doi:10.1080/14740338.2018.1415323
U.S. Food & Drug Administration.Drug advertising: A glossary of terms.
O’Connor N.FDA boxed warnings: How to prescribe drugs safely.Am Fam Physician; 81(3):298-303.
U.S. Food & Drug Administration.New safety measures announced for extended-release and long-acting opioids.
U.S. Food & Drug Administration.Patient labeling resources.
