7/14/2015
Last week, the FDA increased the level of warning for NSIADS such as ibuprofen and naproxen. The new warning states that NSAID use increases heart attack risk.. The former warning stated that use “may” increase the risk.
Non-steroidal anti-inflammatories (NSAIDS) are popular for their ability to relieve pain, reduce inflammation and lower fevers. They’re available over the counter as Advil and Motrin (ibuprofen) and Aleve (naproxen) as well as by prescription.
The update is the result of recent studies that show the risk of heart attack increases within the first few weeks of use even in patients who take the drugs for a short time. Especially at risk are those who have already had a heart attack or who have had cardiac bypass surgery. The FDA further suggests that patients consult their doctors before using NSAIDS if they have a history of cardiovascular disease or high blood pressure. Other health officials, such as Judy Racoosin, the deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products, take an even more cautious position.
“Everyone may be at risk — even people without an underlying risk for cardiovascular disease.”
From the FDA website:
“Based on our review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:
- The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
- The risk appears greater at higher doses.
- It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
- NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
- In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
- Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
- There is an increased risk of heart failure with NSAID use.”
Seek immediate medical attention if you’re taking NSAIDs and notice symptoms such as:
- Chest pain
- Trouble breathing
- Sudden weakness in one side or part of the body
- Slurred speech
These symptoms may be indicative of heart attack or stroke.
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