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Health April 2018

Heed That Black Box Warning on a Daily Pain Reliever?

By Carrie Luger Slayback

People have no warning signs that NSAIDs are causing internal damage before ending up in the hospital with a serious medical condition, 10% of which end in death.

“NSAIDs Responsible for Thousands of Deaths,” read a headline. “More sensational baloney,” I thought.

First, my own NSAID story: In 2007, I caught the toe of my running shoe in a sidewalk crack, went down, banged my knee on cement, and made a little tear in the meniscus. Got up, went on running, but later the knee stiffened and I couldn’t straighten it. Went to the orthopedist, got ibuprofen 800mg “horse pills,” prescribed twice a day. “I can’t wait for my next fix,” I told my husband. Blessed pain relief!

But, yes, that headline was true. Deaths occur from common pain pills. According to WebMd: “FDA Strengthens Warning on NSAIDS and Heart Risk.” Kathleen Doheny of WebMd Health News, lists “short term use of meds” like aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin carry risks of heart disease and stroke. “And it’s true for people without heart disease.”

The innocent ibuprofen, taken for pain could send me to the hospital or the mortuary?

Nutrition Digest (V 38, No. 1) quotes a 1998 Journal of Medicine article: “Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated.” 

Hey, that was 20 years ago. The FDA finally issued a “black box warning” in 2010: “NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.” Other potentially fatal events include gastrointestinal problems and congestive heart failure.

Problems increase with age, history of heart disease and length of use. Troubling because NSAIDs, according to Nutrition Digest, “constitute…more than 70 million prescriptions and more than 30 billion over the counter tablets sold annually in the U.S.”

Has it occurred to you that we’d never suspect the serious health event we or a loved one suffered, was caused by the common ibuprofen?

Yet, Nutrition Digest says: “The toxic effects [of NSAIDs] remain mainly a ‘silent epidemic,’ with many physicians and most patients unaware of the magnitude of the problem.” And those high number of deaths do not include over-the-counter NSAIDs.

The article goes on to cite even more disturbing information. “People have no warning signs that NSAIDs are causing internal damage before ending up in the hospital with a serious medical condition, 10% of which end in death.”

And though the FDA suggested that NSAID use accounted for 10-20,000 deaths a year, There was no large-scale public alert. Instead the FDA opted for a warning label on the box. Such a warning is the strongest language the FDA requires on a medicine box. It means medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.

Then in 2015, the FDA felt the need to strengthen its 2010 black box warning, years after its own mortality figures shown above.

Specific changes for the updated 2015 black box warning listed on the FDA’s “ForConsumers/ConsumerUpdates” site say:

* 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 risk free.

* People who have had heart attacks have increased risk of another heart attack or dying of heart attack-related causes when treated with NSAIDs.

* The risk is also present in people without cardiovascular disease. Everyone may be at risk.

I never read that stuff on the box, or maybe skim it dismissively — “That’ll never happen to me.” My gratitude, nine years ago, for the relief of the ibuprofen prescription, matches millions of “NSAID-takers” in pain. Few know of the risk, most will ignore a threatening black box warning which may let the FDA off the hook, but won’t change consumer habits.

Classes of NSAIDs (non steroidal anti-inflammatories) and prescription Cox-2 inhibitors “work to block the effects of chemicals that increase the feeling of pain and reduce swelling” of whatever hurts, but regrettably, are “likely to cause a different reaction somewhere else, too.”

So, relieving pain for the “occasional headache or backache is probably safe, but the bigger risks are for people who take NSAIDs for the long term. YIKES! “More than half of all bleeding ulcers are caused by NSAIDs” a problem circumvented by taking the Cox-2 inhibitor but their real downside is the increased risk of heart attack, stroke, serious skin reactions.  Cox-2 are prescriptions, but all over-the-counter NSAIDs can cause high blood pressure and kidney damage.

Yet, WebMd goes on to say that “focus on the side effects has made people lose confidence in a very valuable category of drugs.” And non-NSAID “painkillers have their own drawbacks.”  Tylenol does not reduce inflammation and prescription narcotics like OxyContin, Percocet and Vicodin can be addictive.”

Here’s what seems to be good sense regarding NSAID use:

* Short term is best.

* Long term use needs doctor’s consultation. “People respond better to certain NSAIDs,” although nobody know why. A pharmacist, available without appointment, could be a valuable consultant. If people waiting behind you at the drug store makes you uncomfortable, call.

* Read the label and do not take more often than recommended or a greater dose. 

* People with multiple conditions should resist the impulse to grab an over-the-counter  pain killer without careful medical consultation. WebMd notes, “If you're seeing a number of experts, you might be getting a lot of contradictory advice. Cardiologists…focus on the risks. Rheumatologists who treat arthritis tend to focus on the benefits… Getting [patients] the correct medicine requires a careful balancing act.”

* Patients should also look for techniques to reduce pain that don't rely on medication — like biofeedback, acupuncture, hypnosis, and yoga." Depending on your condition, physical therapy, exercise and weight loss – if you're overweight – can also improve your symptoms.

Everyone has bottles of common pain relievers. Few think about risks of grabbing a bottle and swallowing. Magic. They work so often. Appreciate their help but do not assume they are 100% safe just because they’re commonly used. They’re not.


Carrie Luger Slayback an award-winning teacher and champion marathoner, shares personal experience and careful research. Contact her at This email address is being protected from spambots. You need JavaScript enabled to view it. .

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