FDA Revs Up WARNING on Ibuprofen, Aspirin, and Other NSAIDS

PillsThe U.S. Food and Drug Administration (FDA) has known for years that taking popular nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil), Aleve and Celebrex may be dangerous for your heart.

It was 2005 when the agency first warned that taking NASIDs increases your risk of heart attack or stroke, either of which can be fatal. Unfortunately, this wasn’t until after the NSAID Vioxx caused up to 140,000 heart attacks in the five-year period it was on the market (it was pulled from the market in 2004).

Today the heart warning is already included in the Boxed Warning section of prescription drug labels, but since the drugs are so widely used, and in light of a new review, the FDA has taken the “unusual step” of strengthening the warning.[i]

The new warning was recommended by an expert panel, which reviewed safety information on both prescription and over-the-counter (OTC) NSAIDs, including observational studies, a large combined analysis of clinical trials, and additional scientific publications. The FDA’s new warning includes the following:[ii]

  • Your risk of heart attack or stroke may increase as early as the first weeks of using an NSAID.
  • Your risk may increase the longer you use the NSAID.
  • The risk appears greater at higher doses.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease.
  • 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.

The FDA further stressed that both you and your doctor should “remain alert for heart-related side effects” the entire time NSAIDs are being taken. As mentioned, they can occur after just a couple of weeks of use and you may be affected even if you’re healthy and have no risk factors for heart disease.

And it’s not only heart risks you need to be concerned about. NSAIDs, including even OTC options like aspirin, are notorious for being hard on your gastrointestinal tract, leading to potentially fatal side effects such as bleeding in your digestive tract, ulcers and perforation of your stomach or intestines.

NSAIDs, which are one of the most common drug classes used to treat joint pain, may even disrupt cartilage synthesis and actually speed up the destruction of cartilage and joints.

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[i] Harvard Health Publications July 13, 2015

[ii] U.S. Food and Drug Administration July 9, 2015

Filed Under: Medications
Written By:  Updated:
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Jesse Cannone, CFT, CPRS, MFT

Jesse is the co-founder and visionary CEO of The Healthy Back Institute®, the world-leading source of natural back pain solutions. His mission as a former back pain sufferer is to help others live pain free without surgery and pharmaceuticals.

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2 thoughts on “FDA Revs Up WARNING on Ibuprofen, Aspirin, and Other NSAIDS”

  1. prayoon says:

    I am supprised to read your long articlsl to disredit all the famous painkilling medicins which save most people’s live in a long history. Then you introduce your own thing call Heal-n-Shoothe,”God in a bottle”.
    But on every bottle of HnS , you declare that : This product and its statements have not beedn evaluated by the FDA. This product is not intended to treat, cure or prevent any discease. So after you propagding your product and ask your customers to beliefe and use it you imediate totally negate amd deny it yourself.
    What is the matter? How could I trust your product?

  2. Steve says:

    Prayoon, Let me clear some things up…

    1. The FDA does not and has never approved or disapproved any supplements, none at one ever… Now they will disallow, certain ingredient and not let the supplement industry use a that ingredient.

    2. This statement is mandated by the FDA, that is be on all supplement bottles, so every product sold in the USA has this statement on it, no exceptions.

    “This product and its statements have not been evaluated by the FDA. This product is not intended to treat, cure or prevent any disease.”

    3. The Statement “God in a bottle” is a comment one of our customers made about Heal n Soothe, not us.

    4. Please take the time to read through our Quality Assurance page for our position on our product and why and how we know our product are clean and safe…

    Steve HBI-Staff

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