Popular heartburn drugs linked to higher death risk

July 4, 2017
Millions of US residents take proton pump inhibitors which are widely prescribed to treat heartburn, ulcers and other gastrointestinal problems. The drugs also are available over the counter under brand names that include Prevacid, Prilosec and Nexium. Now, a new study from Washington University School of Medicine in St. Louis shows that long-term use of the popular drugs carries an increased risk of death. Credit: Robert Boston

Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School of Medicine in St. Louis shows that longtime use of the drugs also is associated with an increased risk of death.

Millions of U.S. residents take which are widely prescribed to treat heartburn, ulcers and other gastrointestinal problems. The drugs also are available over the counter under brand names that include Prevacid, Prilosec and Nexium.

For the study, the researchers examined of some 275,000 users of PPIs and nearly 75,000 people who took another class of drugs - known as H2 blockers - to reduce stomach acid. The research is published online July 3 in the journal BMJ Open.

"No matter how we sliced and diced the data from this large data set, we saw the same thing: There's an increased risk of death among PPI users," said senior author Ziyad Al-Aly, MD, an assistant professor of medicine. "For example, when we compared patients taking H2 blockers with those taking PPIs for one to two years, we found those on PPIs had a 50 percent increased risk of dying over the next five years. People have the idea that PPIs are very safe because they are readily available, but there are real risks to taking these drugs, particularly for long periods of time."

Both PPIs and H2 blockers are prescribed for serious medical conditions such as upper gastrointestinal tract bleeding, gastroesophageal reflux disease and esophageal cancer. Over-the-counter PPIs are most often used for heartburn and indigestion.

PPIs have become one of the most commonly used classes of drugs in the United States with 15 million monthly prescriptions in 2015 for Nexium alone, according to WebMD.

A kidney doctor by profession, Al-Aly has previously published studies linking PPIs to kidney disease, and other researchers have shown an association with other . Al-Aly, first author Yan Xie, PhD, a data scientist, and colleagues reasoned that since each of these side effects carries a small risk of death, together they may affect the mortality rate of PPI users.

To find out, the researchers sifted through millions of de-identified veterans' medical records in a database maintained by the U.S. Department of Veterans Affairs. They identified 275,933 people who had been prescribed a PPI and 73,355 people prescribed an H2 blocker between October 2006 and September 2008, and noted how many died and when over the following five years. The database did not include information on cause of death.

Drugs called proton pump inhibitors, or PPIs, help alleviate symptoms from heartburn and ulcers by reducing levels of stomach acid, but they also have been linked to problems such as fractures, dementia and kidney disease. And a new study from researchers at Washington University School of Medicine in St. Louis indicates that people who take ppis for a long time also appear to be at an increased risk of death. Jim Dryden has more... Credit: Washington University BioMed Radio

Al-Aly and colleagues found a 25 percent increased risk of death in the PPI group compared with the H2 blocker group. The researchers calculate that, for every 500 people taking PPIs for a year, there is one extra death that would not have otherwise occurred. Given the millions of people who take PPIs regularly, this could translate into thousands of excess deaths every year, Al-Aly said.

The researchers also calculated the risk of death in people who were prescribed PPIs or H2 blockers despite not having the gastrointestinal conditions for which the drugs are recommended. Here, the researchers found that people who took PPIs had a 24 percent increased risk of death compared with people taking H2 blockers.

Further, the risk rose steadily the longer people used the drugs. After 30 days, the risk of death in the PPI and H2 blocker groups was not significantly different, but among people taking the drugs for one to two years, the risk to PPI users was nearly 50 percent higher than that of H2 blocker users.

Although the recommended treatment regimen for most PPIs is short - two to eight weeks for ulcers, for example - many people end up taking the drugs for months or years.

"A lot of times people get prescribed PPIs for a good medical reason, but then doctors don't stop it and patients just keep getting refill after refill after refill," Al-Aly said. "There needs to be periodic re-assessments as to whether people need to be on these. Most of the time, people aren't going to need to be on PPIs for a year or two or three."

As compared with the H2 blocker group, people in the PPI group were older (64 years old, on average, versus 61) and also somewhat sicker, with higher rates of diabetes, hypertension and cardiovascular disease. But these differences cannot fully account for the increased risk of since the risk remained even when the researchers statistically controlled for age and illness.

Over-the-counter PPIs contain the same chemical compounds as in prescription PPIs, just at lower doses, and there is no way to know how long stay on them. The Food and Drug Administration recommends taking PPIs no longer than four weeks before consulting a doctor.

Al-Aly emphasizes that deciding whether to take a PPI requires a risk-benefit calculation.

"PPIs save lives," Al-Aly said. "If I needed a PPI, I absolutely would take it. But I wouldn't take it willy-nilly if I didn't need it. And I would want my doctor to be monitoring me carefully and take me off it the moment it was no longer needed."

Explore further: Proton pump inhibitors do not contribute to dementia or Alzheimer's disease

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dogbert
not rated yet Jul 04, 2017
The use of PPIs in hospital patients is disturbing. ICUs and Critical Care units are filled with patients who have been prescribed PPIs.
Gigel
not rated yet Jul 04, 2017
If the issue is a bacteria-induced gastritis or ulcer, the ill person could try to avoid foods and drinks with high amounts of sugar. That way the bacteria will have less food to eat and will develop less. I know form some personal experience that sugary drinks can lead to stomach ache. The problem is with higher amounts of sugar; a little sugar is not bad.
gtbarron
not rated yet Jul 04, 2017
These types of studies are almost pointless. They do not expose the most important common denominator which would be cause of death. They do not establish mechanism of injury. They do even establish cause and effect. They do not adequately control for variables and in the case of this study it only pertains to veterans who typically are not representative of the population at large. So _at best_ all this study can say is that without adequate controls of variables such as smoking, alcohol use, co-morbid conditions and other medications PPIs _might_ cause an increased risk of death in veterans. Sadly, that is not how it will usually be reported or interpreted by the media or the average reader many of whom will stop taking their PPI and possibly develop life threatening consequences.
KelDude
not rated yet Jul 04, 2017
I have been on Nexium for years. I have acid reflux burning almost constantly if not using the drug. My doctor insists on this because he says that I will definitely get cancer of the esophagus. I take a nexium every three days and the reflux is completely controlled. What bothers me about this and previous stories on PPI's is they never ever say what level of nexium use is a problem. From my point of view, one every three days must be safer than a daily dose. Time will tell. If I die early, I'll leave a comment to advise others it's not as safe as I thought.
dogbert
not rated yet Jul 04, 2017
KelDude,
If you have to use a particular drug, you just have to. Have you tried an H2 blocker like Zantac?
rrrander
5 / 5 (1) Jul 05, 2017
Anyone who stops taking PPI's based on this is a fool. Acid reflux is a debilitating problem not dealt with with plain anti-acids and it eventually leads to esophageal cancer. The risk of PPI's is well-worth it.
Pooua
1 / 5 (1) Jul 05, 2017
I took prescribed Prevacid for a decade. My dad said I needed to get off it, no matter how, but I told him that my heartburn was too horrible without it. He said to cut dairy from my diet, which also seemed really difficult, as it was one of the most common things I ate. However, I did greatly reduce the amount of milk I bought. I had been having problems with lactose intolerance for a long time, but even lactose-free milk often upset my stomach. I found that once I cut or greatly reduced grocery store milk from my diet, I didn't need Prevacid. I still sometimes drink a few spoonfuls of Maalox at night, maybe once to three times every two or three weeks. Oddly enough, I have no trouble drinking raw, whole milk from the local dairy.
awayneramsey
not rated yet Jul 05, 2017
PPIs or proton pump inhibitors (for acid reflux) are remarkable modern medicines, but those of us who use them must limit these to approximately 1-month or less. According to contra/indications printed on the label of some of these, one side-effect might be anemia, e.g. Famotidine. The words "use only as prescribed" should be heeded and these medications should be easily accessible OTC, that is "over-the-counter." Some of us do not require the "mothering" of a physician to use our much-needed medicines responsibly. We can manage.
postfuture
not rated yet Jul 17, 2017
In many cases acid reflux is just a common side effect of taking antibiotics and can be treated with probiotics and different fermented products, including yogurt, kefir, sauerkraut, pickles, miso. But you have to be patient, it can take several months.

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