Regulatory Focus™ > News Articles > FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

Posted 06 November 2017 | By Zachary Brennan 

FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday.

"Because of the potential side effects associated with long-term aspirin therapy, FDA recommends that any cardiovascular-related imagery on OTC aspirin labels be accompanied by a statement that reminds consumers to talk to their health care provider before using aspirin for the professional indication of secondary prevention of cardiovascular events," the guidance says.

The six-page guidance was issued because of the potential side effects associated with long-term aspirin therapy, FDA said.

The agency says the statement – "Talk to your doctor or other healthcare provider before using this product for your heart" – should appear in reasonable proximity to the cardiovascular related imagery and with similar prominence in at least 6-point type size font on the principal display panel.

In terms of the difference between the draft from January and final guidance, FDA said it revised the recommended statement to make it more consumer friendly.

Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry


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