FDA’s Latest Move Against Aspirin for CVD Primary Prevention: A Picture Is Worth 11 Words
Want a pretty picture on your aspirin product packaging? You’ll also need a bold written reminder telling buyers to consult their doctors.
New draft guidance issued by the US Food and Drug Administration (FDA) states that companies using heart-related images on the packaging for their over-the-counter aspirin need to also include language reminding patients to consult their healthcare providers before taking the product.
The action appears to be the latest strike against the “aspirin-a-day keeps the doctor away” mentality that once supported a wider role for aspirin in the primary prevention of cardiovascular disease. Last year the United States Preventive Services Task Force (USPSTF) concluded that aspirin for primary prevention of cardiovascular disease could only be recommended for individuals 50 to 69 years of age with a 10% or greater 10-year risk of MI or stroke. Previous USPSTF guidance had recommended aspirin for a much wider group of patients.
The latest USPSTF update came on the heels of an FDA decision not to grant a primary prevention indication to aspirin-manufacturer Bayer due to the bleeding and stroke risks associated with daily aspirin.
In the FDA’s draft document, released Thursday, the agency states that a number of over-the-counter aspirin products contain “cardiovascular-related imagery”—hearts, electrocardiogram graphics, or stethoscopes—presumably used to suggest to consumers that this is a drug that helps the heart. The agency will not take action against companies for using these images, the draft document notes, but it will require any manufacturers using these images to include the statement: “Consult your healthcare provider before using this product for your heart.”
This language would need to appear “with sufficient prominence” and “reasonable proximity” to the imagery, the FDA document states.
The draft guidance is intended for industry and will be open to comments for a period of 60 days.
US Food and Drug Administration Draft Guidance: Recommended statement for over-the-counter aspirin-containing drug products labeled with cardiovascular related imagery. Guidance for Industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536506.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery Published on: January 12, 2017. Accessed on: January 13, 2017.