FDA Strengthens Warning Of Heart Attack, Stroke Risk for NSAIDs.

By Dr Deepu

FDA Strengthens Warning Of Heart Attack, Stroke Risk for NSAIDs.

ABC World News (7/9, story 11, 1:15, Muir) reported that the Food and Drug Administration strengthened its warning about risks associated with popular pain medicines Advil (ibuprofen), Motrin (ibuprofen), and Aleve (naproxen).

        NBC Nightly News (7/9, story 3, 2:00, Holt) reported that FDA officials now believe that the evidence is “conclusive” that non-steroid anti-inflammatory drugs (NSAIDs) “can increase the chance of heart attack and stroke.”

        The CBS Evening News (7/9, story 10, 0:25, Pelley) reported that the risks are present even with short-term use of 10 days or less.

        According to New York Times (7/10, A20, Tavernise, Subscription Publication), current labels for these over-the-counter drugs indicate they “may cause” an increased risk of heart attack or stroke. However, the FDA believes that “new data from a recent analysis provided stronger evidence of the increased risk of heart failure from such drugs.”

        The Wall Street Journal (7/10, A4, Burton, Subscription Publication) reports that the agency will request the manufacturers change the safety labels on the drugs to indicate the drugs cause increased risk of heart failure within the coming months.

        The Los Angeles Times (7/10, Healy) reports in “Science Now” that the warnings will also point out that “the higher risk of stroke or heart attack is evident in the first weeks a patient starts taking such drugs, that the risk appears to escalate at higher doses and with longer use, and that even people with no other cardiovascular risk factors are more likely to suffer heart attack or stroke when taking the medications.”

        The AP (7/10, Perrone) reports that “the labeling change is the latest step in the FDA’s ongoing safety review of the drugs, which stretches back to 2004,” when “Merck & Co Inc. pulled its blockbuster pain reliever Vioxx [rofecoxib] off the market because of links to heart attack and stroke.”

        Also covering the story are the NBC News(7/10, Fox) website, HealthDay (7/10, Thompson),MedPage Today (7/10, Brown), and Medscape(7/10, Brown).