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The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.
On Nov. 6, 2017, FDA release guidance regarding the use of cardiovascular-related imagery used in the labeling and packaging of over-the-counter (OTC) aspirin products. The guidance recommends that OTC aspirin products that have such images include a statement reminding consumers to discuss the use of aspirin with their doctors before taking the OTC product as a prevention for cardiovascular events.
According to the agency, images such as heart symbols used on packaging of aspirin may imply that these OTC products are intended for the prevention of heart-related incidents. The guidance states that while “secondary prevention of cardiovascular events is permitted as an indication for aspirin in professional labeling (21 CFR 343.80),” FDA wants to promote safe use of OTC aspirin. FDA has published proposed rules in the past requiring statements to be printed advising patients to consult their doctor before using OTC aspirin for cardiovascular events, but these rules were not finalized.
“… FDA does not intend to take action against manufacturers of single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, marketed pursuant to the TFM for IAAA Drug Products because the product label includes cardiovascular related imagery such as the heart image, if the label also includes the following statement: Talk to your doctor or other healthcare provider before using this product for your heart,” the guidance states.
The recommended statement should appear in proximity to any heart imagery in at least 6-poing type size on the principal display panel.