The US Food and Drug Administration (FDA) is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that NSAIDs can increase the chance of a heart attack or stroke, either of which can lead to death. Current labeling on both prescriptions and OTC NSAID medications warns of increased risk of heart-related adverse effects if the medications are used long-term. However, the new warning states that heart attacks and strokes can occur in the first few weeks of taking the drugs. The agency also warns that the risks increase with higher doses of the drugs. The updates are based on an FDA review of recent studies and recommendations by outside advisers. “In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke,” the agency notes in the announcement posted to its website.
In 2004, Merck & Co Inc., pulled its pain reliever Vioxx off the market due to links to heart attack and stroke. Vioxx had been introduced as an NSAID offering fewer gastrointestinal side effects. In 2005, FDA added boxed warnings to all prescription NSAIDs and similar warnings to OTC NSAIDs advising patients to use the medications for the shortest period of time (eg, less than 10 days) and at the lowest possible dose levels. This strengthened warning alerts patients with cardiovascular disease that they are at greatest risk for cardiac adverse events from NSAID use. FDA also reminds consumers of the dangers of combination medications that may expose them to excessive dosage levels of NSAIDs.
A study last year examined cardiac events in prescription NSAID use.
More articles about NSAIDs may be found here.
Read the US Food and Drug Administration consumer update published on their website.