Fitness Files: Risks of your common pain reliever

By Carrie Luger Slayback

Aug. 3, 2016 12:37 PM PT

“NSAIDs Responsible for Thousands of Deaths,” the headline read.

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. I got up and went on running, but later the knee stiffened and I couldn’t straighten it.

I 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. Pain relief!

But, yes, it’s true. Deaths occur from common pain pills. According to WebMd, “FDA Strengthens Warning on NSAIDS and Heart Risk.” Kathleen Doheny of WebMd writes that “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, a publication of the American Nutrition Assn., 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 17 years ago. The FDA 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 that 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 10,000 to 20,000 deaths a year, “There was no large-scale public alert. Instead the FDA opted for a warning label on the box.”

Then, in 2015, the FDA felt the need to strengthen its 2010 black box warning, notably 18 years after release of its own mortality figures above.

By the way, a “black box 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 effects.

Specific changes for the updated 2015 black box warning listed on the FDA’s “For Consumers/Consumer Updates” 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 I skim it dismissively: “That’ll never happen to me.” My gratitude, nine years ago, for the relief of the ibuprofen prescription, matches that of millions of NSAID-takers in pain.

Few know of the risk and most will ignore a threatening “black box warning,” which may let the FDA off the hook but won’t change consumer habits.

Is there a smart way to use NSAIDs? I’ll keep reading to find out what I can and report back.

Newport Beach resident CARRIE LUGER SLAYBACK is a marathoner in her 70s who brought home first places in LA Marathons 2013 and 2014 and the Carlsbad Marathon 2015. She lives in Newport Beach.