How much? How often?

The new FDA warning on NSAIDs seems to be don’t take too much too often but is vague on what that is.  From FDA.gov:

Next time you reach into the medicine cabinet seeking relief for a headache, backache or arthritis, be aware of important safety information for non-steroidal anti-inflammatory drugs.

FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance 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, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)

Reading a warning like this makes us old guys with arthritis really interested in how much and how often.  FDA doesn’t really say other than

FDA added a boxed warning to prescription drug labels for this risk in 2005. More recent data and information are prompting FDA to update NSAID labeling. Today we know 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,” says Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

As a regular user of ibuprofen and aspirin for arthritis and reminders that I wasn’t as indestructible as I thought I was a half-century ago, stuff like this is absolutely meaningless.  (And, yes, my doc knows how much and frequency.)

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14 responses to “How much? How often?

  1. luisadownunder

    Ahh, that most meaningless of all words, “may”.

  2. Now that ASA is rated less dangerous than previously , I wonder how the old pyrazolidines would rank vs. the latest NSAIDS….
    Does the ‘n’ in the ‘COX-n’ inhibitor define the kind of side-effect risk? It seems to be the case………
    Rheumatologists told me 50 years ago that arthritics would take the stomach-ulcerating phenylbutazone ad nauseum preferring the hematemesis to the arthritis………..
    These drugs were formerly termed ‘prescription poisons’, it seems that having the cure worse than the complaint is always a possibility……

    • “prescription poisons” is term used by charlatans to sell their own brand of either useless or equally poisonous solutions to ailments. It has no scientific meaning whatsoever.

      • Here in NZL the terms ‘Prescription poison’ and ‘Dangerous drug’ had statutory meaning in the past…
        Both classes were available only on prescription….
        Dangerous drugs included all addictive substances except ethanol and nicotine, of course…..

        • Thank you for the clarification. I had not heard the term “prescription poison” except used in a derogatory was to describe drugs people opposed in the US. Other countries obviously use it differently.

  3. The clot genesis is measured against the GI bleeding and the risks are there.

  4. Interesting – and it was just a few weeks ago we learned taking 1 Advil a day could greatly extend your life. I am confused by conflicting Junk Science :S
    http://m.huffpost.com/us/entry/6354856

    • “the lifespan of Saccharomyces cerevisiae, Caenorhabditis elegans and Drosophila melanogaster”—works on yeast, nematodes and fruit flies. Nothing about people in there, though. Maybe that’s why it’s confusing.

      • I agree the study was done on various insect like critters, but the press sure IMPLIED, that this would work for humans, potentially increasing Human lifespans by up to 12 years. A figure that probably came out of thin air, to make a cool sounding press release.

        • At least you recognize the study was done on insects and that this is important. Yes, the press seemed to believe this applied to people, too, even though that is not what the study showed. Many people are not going to realize that bugs and people are fundamentally different. (A terrifiying thought, really, that people can be so lacking in understanding.)

  5. Does anyone have a source for the studies on which this is based? I have been searching because I’d like to see actual numbers studied and how the studies were ran. An “increased risk” is often meaningless if your risk was one in 100,000 to start with. Double the risk and it’s 2 in 100,000. Not that scary, really.

  6. B.G. ‘As a regular user of ibuprofen and aspirin’….You seem to have got it right ….. The ‘literature’ implies that if you alternate the two at 8-hour intervals, you are cured, with the side effects tending to cancel…….
    BUT: Please don’t challenge me to a tennis match…..I have the imaginary ME / SAIS

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