Nonsteroidal anti-inflammatory agents (NSAIDs) are medications that can relieve pain and reduce fever. These drugs include over-the-counter-and prescription medications such as aspirin, Motrin, Aleve, Anaprox, and Celebrex. Most medications have untoward side-effects and NSAIDs are no exception. They have been linked to an increased risk of heart attacks and stroke. On July 9, the Food and Drug Administration (FDA) strengthened its existing warning on both over-the-counter and prescription NSAIDS.
The FDA is strengthening an its existing warning placed on NSAID Drug Facts labels to note that the medications can increase the risk of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID; furthermore, the risk might rise the longer an individual takes an NSAID. The agency notes that, although aspirin is an NSAID, this revised warning does not apply to aspirin.
The FDA cautions that many prescription and over-the-counter medications contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient. The agency notes that prescription NSAIDs are an effective treatment for the symptoms of many devastating conditions such as osteoarthritis, rheumatoid arthritis, and gout. Over-the-counter NSAIDs are used to temporarily lower fever and to treat minor aches and pains such as headaches, toothaches, muscular aches, backaches, tendonitis, sprains, strains, and menstrual cramps. Furthermore, some combination medicines, which relieve various symptoms, such as multi-symptom cold products, contain NSAIDs.
“Be careful not to take more than one product that contains an NSAID at a time,” cautioned Karen M. Mahoney, M.D., deputy director of FDA’s Division of Nonprescription Drug Products. She recommended that one should check the list of active ingredients in the Drug Facts label. At present, the labels for both prescription and over-the-counter NSAIDs have information on heart attack and stroke risk. In the coming months, the FDA will require manufacturers of prescription NSAIDs to update their labels with more specific information regarding heart attack and stroke risks. The agency will also request that the manufacturers of over-the-counter NSAIDs update the heart attack and stroke risk information in Drug Facts labels.
In 2005, the FDA added a boxed warning to prescription drug labels for heart attack and stroke risk. Since then, clinical studies have provided additional information regarding these risks, such as data showing that the risk of heart attack and stroke may occur early in treatment, even in the first weeks. “There is no period of use shown to be without risk,” explained Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
Individuals who have cardiovascular disease, particularly those who recently suffered a myocardial infarction (heart attack) or cardiac bypass surgery, are at the highest risk for cardiovascular adverse events associated with NSAIDs. The FDA is adding information in the drug label for individuals who already have had a heart attack. According to recent studies, this vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they are treated with NSAIDs. However, the risk also exists for individuals without cardiovascular disease. “Everyone may be at risk, even people without an underlying risk for cardiovascular disease,” noted Dr. Racoosin.
The FDA offers the following information to consumers regarding NSAIDs. The medications are effective treatments for pain, inflammation, and fever. Consumers can continue taking them but should be aware of this increased risk of heart attack or stroke, especially at higher doses. When using prescription NSAIDs, read the consumer-friendly Medication Guide attached to the prescription; it provides important safety information. If you have heart disease or high blood pressure, consult a healthcare professional before using an NSAID. Balance the benefits of NSAIDs with the possible risks and weigh the options. If you take low-dose aspirin for protection against heart attack and stroke, you should know that some NSAIDs, including ibuprofen and naproxen, can interfere with that protective effect.
Stop taking NSAIDs and seek medical help if you experience symptoms that might indicate a heart problem or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech. Reduce your risk factors for heart disease and stroke. “Smoking, high blood pressure, high cholesterol, and diabetes are major risk factors for these conditions,” cautions Dr. Mahoney. She adds, “If you smoke, work on quitting. See your doctor regularly to find out if you have these other strong risk factors, and commit yourself to taking care of them and of your health.”
