For decades, people have spent billions on such drugs as Prevacid, Prilosec and Nexium to treat heartburn; in fact, Nexium’s $6 billion in sales a year makes it one of nation’s top-selling drugs.
But stop the music. Stomach acid isn’t a bad thing — if it stays in the belly. In fact, stomach acid is necessary for proper digestion and absorption of minerals, vitamins, B-12 and nutrients, with further responsibilities in killing bad, and fostering good, bacteria in the stomach and intestinal tract.
So it should be no major surprise that using these anti-acid drugs for months, years and even decades to treat gastro-esophageal reflux disease or GERD, can cause unwanted health consequences.
For sure, a steady stream of peer-reviewed studies has linked extended use of these strong anti-acid drugs with various health problems including chronic kidney disease, osteoporosis and higher risk of fractures, pulmonary tuberculosis, gastric and esophageal cancers, and even dangerous drug interactions.
The U.S. Food and Drug Administration last year warned that what are known as proton-pump inhibitors — which are now available over the counter — can lead to pneumonia and Clostridium difficile, the gastro-intestinal infection known as C-diff that takes hold when protective bacteria are eliminated by antibiotics or other agents affecting gut chemistry.
“Reflux is an esophageal-sphincter disease, so what makes suppressing acid for the rest of your life a good thing?” asked Todd Berg, CEO of Torax Medical Inc., a St. Paul, Minn., company that produces a device to help correct the sphincter dysfunction causing reflux.
“Giving patients these drugs is coming home to roost. It’s a failure of the medical community in treating this disease,” he said.
There are 15 million people currently using these acid reducing drugs in the United States because of their effectiveness in controlling heartburn.
As Mr. Berg noted, dysfunction of the lower esophageal sphincter, which doesn’t close properly after swallowing food, allows stomach acid to backflow into the lower esophagus, with resulting irritation causing heartburn. These drugs mask the effect of — rather than halt the flow of — stomach juices. That can lead to tissue changes known as Barrett’s esophagus, which brings a heightened risk of esophageal cancer. This same class of drugs also is used to treat peptic ulcers in the stomach and small intestine and erosive conditions in the esophagus.
But a German study published Feb. 15 in JAMA Neurology, coming on the heels of a previous study, have hoisted red flags for doctors and patients alike by documenting a 33 percent increase in dementia and 44 percent increase in Alzheimer’s disease among seniors using these acid reducing drugs. “The avoidance of [proton pump inhibitor] medication may prevent the development of dementia,” it concludes, based on an analysis of health data along with tests done on mice. The study calls for clinical trials “to examine this connection in more detail.”
“Overall, there’s a risk of dementia based on these articles,” said Lewis H. Kuller, emeritus professor in the department of epidemiology at the University of Pittsburgh Graduate School of Public Health. While not proving that the drugs cause dementia, the study did show an association. “If you don’t need the drug, don’t use it.”
Some physicians have begun prescribing these proton pump inhibitors as a last resort rather than first-line treatment for GERD.
The problem is, “the drug is effective. There is no question about it, it works,” said Dr. Kuller, who wrote the JAMA editorial accompanying the German dementia study, which he describes as solid. “The issue is whether too many people are taking them and whether there are adverse side effects unrecognized by doctors and the public, with people taking these drugs for long periods of time. If the drug causes dementia, then the mechanism may provide important new information.”
Virtually all drugs pose potential risks, he said, “But if you are taking them long term and getting good effects, other drugs can be used, instead.”
AstraZeneca, which produces Prilosec OS and Nexium products, said it wasn’t consulted in any of the proton pump inhibitor studies and for that reason cannot comment about them. However, it stated by email that “patient safety is an important priority for AstraZeneca, and we believe all of our PPI medicines are generally safe and effective when used in accordance with the label.” But those labels, in fact, recommend the drug be used for no longer than 14 days.
“This has been established through human data studies and more than a decade of real-world clinical use,” AstraZeneca said, while encouraging patients “to work with their health care provider to determine the most appropriate treatment approach based on their individual needs.”
Most of the studies detailing potential side effects from the drugs are observational, which means they use similar population groups in comparing the health of those on the drugs vs. those not using them. Such studies can find a link but cannot state whether the drug actually causes the side effects. Still, those links are raising concern.
For example, there’s a clear association between proton-pump inhibitors and bone fractures likely resulting from lack of stomach acid hindering absorption of magnesium, calcium and other nutrients necessary for bone health.
Blair Jobe, director of the Esophageal and Lung Institute in the Allegheny Health Network, said he still prescribes the drugs routinely but now “with a plan in place.” But the studies are prompting his patients to express concerns.
“I saw a 70-year-old lady the other day with osteopenia (thinning bones) who came to me with concern about PPIs. I took her off of them and put her on Zantac,” he said, explaining that Zantac is an Histamine-2 drug, which reduces stomach acid to a lesser degree. Another 18-year-old female patient, he said, made an appointment to state her concerns that the drugs may be posing a risk to bone and mental health.
Dr. Jobe’s study published in 2011 revealed a higher risk of esophageal cancer among those who’ve used proton pump inhibitors over the long term.
“The more people on PPIs, the more side effects,” he said. “Now I’m seeing many patients in the weekly clinic and a larger percentage are coming in to discuss their PPI use due to what they heard in the lay media and literature.”
The drugs are “incredibly hard to get off of because they improve a person’s quality of life so well,” Dr. Jobe said. “Multiple people are on them, and now we see people who’ve been on them for 30 years and you have to understand there is no free lunch here. There is give and take. If you abide by the [instructional] insert, it says, ‘Do not take this product for more than 14 days.’ ”
David Templeton: dtempleton@post-gazette.com or 412-263-1578.
First Published: March 22, 2016, 4:00 a.m.
