FDA Strengthens NSAID Warning for Cardiovascular Risks

On July 9, 2015, the U.S. Food and Drug Administration (FDA) announced that it is strengthening its warning on labels that non-aspirin, non-steroidal anti-inflammatory drugs (referred to as NSAIDs) can cause heart attacks or strokes. These drugs, which include popular OTC medications such as ibuprofen and naproxen, are widely used in the United States.

Prescription and OTC non-aspirin NSAIDs already include information about the risk for heart attack and stroke with NSAIDs, either of which can lead to death, the FDA stated in their news release. Following an extensive review of new safety information, the FDA will now require the drug labels of all prescription and over-the-counter (OTC) NSAIDs to be upgraded to strengthen the warning and reflect the increased cardiovascular risk.

Prescription nonaspirin NSAID labels started including "Boxed Warning" and "Warnings and Precaution" sections in 2005. Since that time, the FDA reviewed new safety information on prescription and OTC NSAIDs that included observational studies, a large combined analysis of clinical trials, and scientific publications.

The FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee discussed these studies at a joint meeting on February 10 and 11, 2014. Based on the FDA’s review and the advisory committee’s recommendations, the updated labels for prescription NSAIDs will be updated to include the following information:

• The risk of heart attack or stroke risk can begin as early as the first weeks of NSAID use, and the risk may increase with longer NSAID use.
• The higher the dose, the greater the risk.
• Although the risk was previously thought to be similar for all NSAIDs, recent information calls this into question. The FDA now says that there is insufficient information to determine whether the risk is higher or lower for one NSAID compared with any other.
• A large number of studies show that both patients with and without heart disease or risk factors for heart disease are at increased risk for heart attack or stroke when taking NSAIDs. Study estimates of the extent of increased risk are varied, depending on the medications and doses studied.
• The risk for heart attack or stroke associated with NSAID use is greater in patients who have heart disease or risk factors for heart disease because their risk is higher at baseline.
• Patients who take NSAIDs after a first heart attack are more likely to die in the year after the heart attack than those who did not take NSAIDs after their first heart attack.
• Patients are at increased risk for heart failure when taking NSAIDs.

The FDA recommends that patients and healthcare professionals remain alert for cardiac-adverse effects for the duration of their NSAID use. Those taking NSAIDs should seek immediate medical attention if they have cardiovascular –related symptoms including chest pain, shortness of breath, difficulty breathing, weakness in one part or one side of their body, or slurred speech.

More information on this alert is available on the FDA website.

Healthcare professionals and patients should report adverse events related to NSAID use to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, via fax at 1-800-FDA-0178, or via mail to the address on the pre-addressed form.