Posted by Kevin F. Smith, M.D., M.P.H.
In case you are wondering about the Food and Drug Administration’s (FDA) plans to strengthen fact label warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs): Use of these medications on a limited basis remains sound clinical practice.
Commonly used OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve). NSAIDs are also often an ingredient in sleep aids and multi-symptom cold and flu remedies.
At WorkCare, initial treatment recommendations typically include the application of ice and use of an OTC NSAID during the first 24-48 hours following a work-related strain, sprain or contusion to reduce localized swelling and discomfort. These first-aid measures are included in protocols followed by our clinicians who assess workers’ complaints and provide care guidance onsite or via our 24-hour Incident Intervention hotline.
The FDA will require updates to drug facts labels to indicate that non-aspirin, prescription-strength and OTC NSAIDs increase the chance of a heart attack or stroke.
Existing labels already state “the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.” Additionally, the label says consumers should not take more than directed and that the smallest effective dose should be used. It also states that OTC NSAIDs are not intended to be used for more than 10 days for pain or three days for fever. Beyond that time, consumers are advised to seek the advice of a physician. People with high blood pressure, heart disease, liver cirrhosis or kidney disease are advised to check with a doctor before taking OTC NSAIDs.
Along with other warnings, WorkCare clinicians will continue to remind potential consumers of heart and stroke risk in relation to using more than or longer than directed.
Based on a review of studies and advisory committee recommendations, the FDA said NSAID labels will be updated to reflect the following:
- Non-aspirin NSAIDs increase the chance of a heart attack or stroke as early as the first weeks of use. Risk may increase with longer use and appears greater at higher doses.
- NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors. In general, patients with heart disease or risk factors have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors.
- In studies, patients treated with NSAIDs following a first heart attack were found to be more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs.
Advice for Consumers
It is important to note that potential cardiovascular side effects have been known about NSAIDs for years and that WorkCare has incorporated this knowledge in its treatment protocols.
We recommend the following:
- Always check labels to learn about therapeutic uses, recommended dose and duration, and potential side effects.
- If you are taking more than one OTC medication, check active ingredients on the side of the container to ensure that you are not using more than one product with the same active ingredient.
- Limit OTC medication use to a few days; consult a medical professional before continuing use.
- If you have heart disease or high blood pressure, consult a health care provider before using an NSAID.
Symptoms that warrant immediate medical attention include:
- Chest pain
- Shortness of breath or trouble breathing
- Sudden weakness or numbness in one part or side of the body
- Slurred speech
Under any circumstances, if you have questions about a drug’s benefits, side effects or how it may interact with other medications, consult a medical professional.
Kevin F. Smith, M.D., M.P.H., a WorkCare consulting physician, has more than 25 years of experience in occupational and preventive medicine. He completed his medical residency training at Yale University and the University of Iowa. He has practiced in the U.S., Sweden and the United Kingdom.