The Long Run

Acid reflux in flux

The FDA warns that long-term use of proton pump inhibitors could have adverse effects. So doctors are reevaluating the popular medication.

By Kay Lazar
April 4, 2011

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Marian Mandell is not a teetotaler. The 65-year-old retired Newton real estate broker enjoys her coffee and savors a nice glass of wine, too — both no-nos for people who struggle with acid reflux because the beverages are thought to worsen the ailment.

On paper, or to be more precise, in her medical records, Mandell is one of those people. She was prescribed an acid reflux medication about eight years ago and has been taking it religiously since, though she can’t remember the last time she even had indigestion.

“I should maybe check,’’ she said, “to find out if I still need to take this.’’

Some doctors are starting to wonder the same thing for their patients, after a warning last month from federal regulators about the most popular type of acid reflux medications. Known as proton pump inhibitors, or PPIs, they include Nexium, Prilosec, Prevacid, and Zegerid.

The Food and Drug Administration’s advisory said patients who take the medications for a long time, generally more than one year, may end up with low magnesium levels, which can put them at risk for seizures, irregular heartbeats, and muscle spasms.

It was the second warning about the medications from the agency in less than a year. Last May, the FDA said the drugs, both sold as prescriptions and over-the-counter, may increase the risk of hip, wrist, and spine fractures, especially for patients who are over 50 and have been taking them for longer than one year or are receiving high doses.

Acid reflux is the backward flow of stomach acid into the esophagus, the tube that connects the throat and stomach. Sometimes the reflux progresses to a more severe form, known as GERD, or gastroesophageal reflux disease, which can irritate the lining of the esophagus and cause frequent heartburn, chest pain, regurgitation of food and liquid, and coughing, often at night when patients are lying down.

Proton pump inhibitor medications, which have been on the market for two decades, work by blocking or decreasing the secretion of acids in the stomach. Sales of the medicines have soared in recent years, growing from 92 million prescriptions dispensed in the United States in 2005 to 118.5 million last year, according to IMS Health, a Pennsylvania-based company that tracks prescription sales. Roughly $11.4 billion worth of the prescriptions were sold last year in this country, the fourth largest amount for a class of drugs, after antipsychotics, cholesterol-lowering statins, and antidepressants, IMS Health found.

The numbers don’t reflect the countless other sales of the drugs over the counter, and Dr. Jacques Carter, a Beth Israel Deaconess Medical Center primary care physician, said it may be time to rethink that availability. He said that, given the new concerns, it might be wiser for regulators to require that drug stores sell the medicines behind the counter, so consumers would have to ask a pharmacist for the product. That way, he said, they may have a better chance of learning about the possible adverse side effects or interactions with other medications.

“At least when I prescribe them to my patients, I am aware of their medical histories and also what other medications they might be taking,’’ said Carter, who is also a Harvard Medical School assistant professor.

Carter said that since the recent FDA warning about low magnesium levels, he is more closely monitoring his acid reflux patients who are also taking certain medications for high blood pressure, because some of those medicines can deplete their magnesium levels, too.

The FDA warnings have prompted Dr. Elisa Choi, a Boston primary care physician with Harvard Vanguard Medical Associates, to reconsider the long-term use of proton pump inhibitors in all of her patients, and not just those with heart disease or older patients with an already higher risk for bone fractures.

“This raises questions about a medication that is widely prescribed and rather casually used,’’ Choi said. “This may be an opportunity for me to rethink, for every single patient, what truly was the indication and need for proton pump therapy.

She said the issue becomes more pressing as patients age and tend to need other medications, such as heart and osteoporosis medicines, which may place them at higher risk for complications from proton pump inhibitors.

Choi, and other doctors, said some patients are able to discontinue the medicines if they make changes in their lifestyle, such as not eating for several hours before bedtime, and sticking to a diet that would not trigger their symptoms. Spicy foods, caffeine, alcohol, chocolate, and some tomato-based dishes, such as spaghetti, can worsen acid reflux symptoms.

Choi said she has had patients who, with some coaching, have been able to make the changes and found they no longer needed the medicine.

But Carter, the Beth Israel Deaconess physician, said his patients often find it hard to forgo problematic foods — “they aren’t going to give up their spaghetti and lasagna,’’ he said — and prefer taking a pill instead.

There are other alternatives.

Dr. Denis McCarthy, a University of New Mexico School of Medicine professor and researcher who treats patients with digestive disorders, has found that many people taking proton pump inhibitors can be switched to another type of acid-suppressive medication, known as an H2 blocker, such as Zantac, that is easy to use and often less expensive.

For a minority of patients with severe acid reflux problems, long-term use of proton pump inhibitors is essential, McCarthy said. Still, he has concerns about the medicine’s potential affect on a patient’s ability to absorb iron. McCarthy said he often sees new patients, particularly those over age 40, who have been on proton pump inhibitors for more than a year and are anemic. A recent study in Digestive Diseases and Sciences pointed to a possible link, but more rigorous research on this is needed, McCarthy said.

Also lacking are large, well-controlled studies that could help doctors understand the best way to wean patients off proton pump inhibitors, said Dr. Robert Burakoff, director of the center for digestive health at Brigham and Women’s Hospital.

Doctors have found that stopping the medicines abruptly can worsen acid reflux symptoms in some patients. So Burakoff said he has either tapered the dosage or instructed patients to take the medicine every other day.

He said there are still many unanswered questions. The most recent FDA warning about low magnesium levels, for instance, suggested that doctors test a patient’s magnesium level prior to prescribing proton pump inhibitors and then “periodically’’ thereafter.

“If we are going to keep a person on PPIs for the long-term, we will have to make a decision about when to check the magnesium again,’’ Burakoff said. “Is it three, or six ,or nine months? It’s unclear.’’

Similarly perplexing, he said, is the warning about potential fracture risks. The studies the federal agency reviewed before issuing its warning did not include information about the patients’ family history, which can make some more susceptible to fractures. Neither did it specify the other types of medications the patients were taking, which also may have elevated their risks.

Since that warning, Burakoff said, he has started suggesting that his patients who are newly prescribed proton pump inhibitors also get a baseline bone density test to assess the strength of their bones before taking the medications.

“The difficulty,’’ he said, “is we don’t know how often to repeat that test.’’

Kay Lazar can be reached at

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