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FDA: OTC aspirin labels with CV imagery should prompt consumers to consult physician
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The FDA issued a draft guidance recommending that labels of over-the-counter aspirin using any CV-related imagery be accompanied by a statement reminding consumers to speak to a health care provider before taking aspirin for prevention of CV events.
This recommendation applies to single-ingredient aspirin, buffered aspirin and aspirin in combination with an antacid, labeled with CV-related imagery marketed under the tentative final monograph for internal analgesic, antipyretic and antirheumatic drug products for over-the-counter (OTC) human use.
Under professional labeling directed to healthcare professionals, OTC aspirin has indications for reducing risk for recurrent MI or stroke. Citing concerns about bleeding risk, the FDA does not allow manufacturers to promote aspirin for primary prevention of CV events.
The agency wrote in the draft guidance that because of potential side effects associated with long-term aspirin therapy such as bleeding, kidney failure and other types of strokes, the message “consult your health care provider before using this product for your heart” should accompany OTC aspirin with any CV-related imagery.
Public comments can be made on the draft guidance until March 13, 2017. Comments can be submitted to www.regulations.gov or to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should include the docket number, FDA-2012-D-0529.
After analyzing comments on the draft guidance, the FDA issues a final guidance, which may or may not be different from the draft guidance.