COX-2 Selective Inhibitors and NSAIDs - Patient Medication Guide Requirement
June 16, 2005
The FDA has requested a labeling change for all prescription and over-the-counter NSAIDs, including COX-2 selective agents. This change requires a boxed warning describing the potential for increased risk of cardiovascular events and life-threatening gastrointestinal bleeding. Additionally, pharmacists and prescribers are now required to give patients a Medication Guide when any prescription NSAID (including COX-2 selective agents) is dispensed. Additional information is available at the following links:
- MedWatch Alert:
- FDA Drug Information:
- NSAID Medication Guide for Patients:
The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. This requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1). However, it may be appropriate to educate inpatients about the potential hazards of prescription medications, at the clinician’s discretion. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
June 16, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.