FDA Issues Guidance on Heart Health Labeling Statements for Aspirin

The Food and Drug Administration on Nov. 6 issued a guidance document on recommended statements for over-the-counter drugs containing aspirin that are labeled with cardiovascular-related imagery. FDA regulations currently allow labeling for cardiovascular events only in professional labeling directed to healthcare professionals, the agency said. However, “FDA does not intend to take action against manufacturers of single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid … 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 agency said.