Study Finds Growing Reason to Be Wary of Some Reflux Drugs

Study Finds Growing Reason to Be Wary of Some Reflux Drugs

Paula Span

THE NEW OLD AGE JAN. 29, 2016

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CreditJoyce Hesselberth

Maybe you have seen television ads starring the beefy, affable comedian and actor known as Larry the Cable Guy.

In his sleeveless shirt and gimme cap, he’s driving a monster truck or streaking along on a jet ski, pausing to chomp on a turkey drumstick or a barbecued rib, all the while proclaiming his love for America and for Prilosec OTC to fight “frequent heartburn.”The caution that the drug should be taken for no more than 14 days, and not more often than every four months, appears briefly on-screen. If you blink or go fetch your glasses, you’ll miss it.

Todd Semla has noticed the ads, too, and he’s not a fan. “I don’t see Larry the Cable Guy saying, ‘If you take this drug often, your kidneys may be affected or you could break a hip,’” said Dr. Semla, a pharmacist at the Feinberg School of Medicine at Northwestern University, and past president of the American Geriatrics Society.

Since their introduction in 1990, the drugs collectively known as proton pump inhibitors (common brand names: Nexium, Prevacid, Prilosec) have become among the most frequently prescribed in the country; as the Cable Guy points out, they are also available over the counter. They suppress stomach acid more effectively than a previous class of drugs called H₂ blockers (Zantac, Tagamet, Pepcid).

They have also given users reason to be wary. In recent years, scores of studies have reported associations between prescription P.P.I. use and an array of health problems, including bone fractures, low magnesium levels, kidney injuries and possibly cardiovascular drug interactions.

They are also linked to infections, like the stubborn Clostridium difficile and pneumonia. Reducing the acidity of the stomach, researchers believe, allows bacteria to thrive and then spread to other organs like the lungs and intestines.

The latest findings, published in JAMA Internal Medicine, point to increased risk of chronic kidney disease among users, which is particularly worrisome.

“You can treat and hopefully cure infections,” said Dr. Adam Schoenfeld, an internal medicine resident at the University of California, San Francisco, and an author of an accompanying editorial on the drugs’ adverse effects. “Fractures can heal, though they can be catastrophic events for older people. But chronic kidney disease doesn’t go away.”

The new study, by a Johns Hopkins team, compiled years of data from two sources: a community sample of 10,482 adults in four communities in North Carolina, Mississippi, Minnesota and Maryland (average age: 63) and a cohort of nearly 250,000 patients in a rural Pennsylvania health care system. Those who took prescription proton pump inhibitors were 20 percent to 50 percent more likely to develop chronic kidney disease than nonusers, said the senior author, Dr. Morgan Grams, a nephrologist and epidemiologist at Johns Hopkins.

Like the rest of these drug studies, this one demonstrated an association, not a direct cause. But in the Pennsylvania sample, the researchers documented a dose effect: The risk of chronic kidney disease rose 15 percent among those taking the drug once a day, but 46 percent in those taking it twice daily, compared with nonusers. “That leads us to believe there’s a causal effect,” Dr. Grams said.

Relative risk statistics sometimes seem to exaggerate the dangers of a drug or an illness, if they were low to begin with. But “kidney disease is quite common, particularly among older adults,” Dr. Grams pointed out. And the P.P.I.-using population is vast, she added. “When you have 15 million people using these drugs, even relatively rare adverse effects can affect a lot of people.”

Older people should probably pay special heed. They are more likely to have reflux, Dr. Semla said, in part because the muscle that prevents stomach acid from rising into the esophagus weakens with age. Older adults are therefore more likely to take these drugs, and also more vulnerable to the diseases and disorders associated with them, especially with long-term use.

All of this led an American Geriatrics Society panel last year to add proton pump inhibitors to the list called the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, citing the risk of bone loss and fractures and C. diff infection.

The Food and Drug Administration has also issued several safety announcements about these drugs’ association with C. diff, fracture riskand low magnesium, linked to kidney disease and other ailments.

So you’d think use of proton pump inhibitors would be declining. It’s not.

“Despite this information, those drugs are extremely overprescribed,” Dr. Schoenfeld said.

From 1999 to 2002, 9 percent of people ages 55 to 64 reported using a prescription gastric reflux drug (including non-P.P.I.s) in the previous 30 days, the Centers for Disease Control and Prevention has reported.

Ten years later, the proportion had risen to 16 percent. Among prescription medications, only cardiac and cholesterol drugs were more commonly used by adults ages 55 to 64.

Proton pump inhibitors can be crucial medications, doctors hasten to point out, for those with peptic ulcers or for intensive care patients, among others. They’re also the most effective option for severe reflux. But whether over the counter or prescribed (prescriptions can involve higher doses), they are usually recommended for short-term use.

Yet “there are definitely older people who’ve been on these for 10 or 20 years,” Dr. Schoenfeld said. Perhaps the medication was prescribed during a hospital stay, then never discontinued. Or a patient took a nonprescription version for a bout of indigestion, felt better and therefore kept taking it, though the initial problem may have long ago disappeared. Doctors, too, often fail to question extended use, Dr. Schoenfeld said.

Regularly reviewing all medications, prescription and over the counter, at office visits might help reduce this overuse. Dr. Schoenfeld recommends tapering off a proton pump inhibitor to see if it’s still needed, or switching to one of the less potent H₂ blockers, which don’t appear to entail the same risks.

Better yet, nonpharmacological approaches can often reduce heartburn and other reflux-related problems. Losing weight helps; so does limiting certain medications, like aspirin. Dr. Semla suggests raising the head of your bed so stomach acid has a harder time climbing.

Moreover, “if people eat a lot of fatty, greasy foods or drink a lot of alcohol or caffeine, those are all triggers for heartburn,” Dr. Schoenfeld said. It probably also helps — “people are going to hate me” — to cut back on chocolate.

“With time or with dietary changes,” he said, “a lot of these symptoms would go away on their own.”

Listen up, Cable Guy.