A new study found that heartburn drugs are linked to an increased risk of early death. The findings were published Monday in the British Medical Journal Open. The authors explained that at prescription strength, proton-pump inhibitors are linked to a possible 25 percent increased risk of early death from any cause.
The authors noted they didn’t examine over-the-counter proton-pump inhibitors or any particular brand of prescription-strength drugs. They also stressed that their study doesn’t prove cause and effect.
The drugs, also known as PPIs, suppress excess acid in the stomach caused by heartburn. Usually, prescription formulas are taken by patients who suffer from severe conditions for extended periods of time, while lower-dose over-the-counter formulas are only approved for short-term use by the US Food and Drug Administration.
Proton-pump inhibitors increase risk of early death by 25 percent
Other studies had already linked proton-pump inhibitors to an increased risk of poor health, according to senior author of the new research, Dr. Ziyad Al-Aly, of the Washington University School of Medicine.
“A number of studies reported that use (of these drugs) is associated with a number of adverse events including kidney disease, fractures, pneumonia, dementia, C. diff infections and cardiovascular disease,” said Al-Aly, according to CNN.
To find whether that increased risk of poor health translated to increased risk of death, Al-Aly and his co-authors looked at US Department of Veterans Affairs on over 3.5 million people. Al-Aly noted that the VA has the largest integrated electronic medical record system in the world, which allowed them to look at a large number of patients and follow them up for six years to examine their research questions.
The researchers compared patients who took proton-pump inhibitors with those who took another type of drug that reduces heartburn: histamine H2 receptor antagonists, also known as H2 blockers. They made other comparisons, too, including patients who took proton-pump inhibitors versus patients who did not take either H2 blockers or PPIs.
If 500 people took PPIs for a year, there would be at least one death related to the drug use
When they analyzed the data, they found that people who took proton-pump inhibitors experienced a 25% heightened risk of early death from all causes compared with those taking H2 blockers.
Al-Aly said that if 500 patients took proton-pump inhibitors for a year, there would be at least one death that may be related to the drug use. He added that the longer patients took PPIs, the higher their risk of early death.
The researchers also compared users of proton-pump inhibitors with non-users of PPIs or H2 blockers and found the same 25 percent higher risk was seen.
“In our studies, however, we looked at the data, there was always a consistent relationship between (proton-pump inhibitor) use and the risk of death,” warned Al-Aly, according to CNN.
The researchers say the biological reason for a link between proton-pump inhibitors and increased risk of early death is not clear yet. The evidence they gathered suggests that these drugs change how genes express themselves, by increasing some DNA activities while decreasing others. They believe that these genetic differences may be responsible for contributing to earlier deaths.
Limiting a patient’s use of PPIs ‘to instances and durations where it’s medically indicated is warranted’
Al-Aly and his colleagues concluded that the growing body of scientific evidence, which shows a host of adverse events, linked with the use of proton-pump inhibitors is “compelling.” They said that limiting a person’s use of these drugs to instances and durations where it is medically indicated may be warranted.
AstraZeneca, a global pharmaceutical company, manufactures two popular products, both of which come in over-the-counter presentations and prescription-strength formulations.
“We are confident in the safety and efficacy of Nexium and Prilosec when used in accordance with the FDA approved label, which has been established through numerous clinical trials,” said Alexandra Engel, a spokeswoman with AstraZeneca, which was not involved in the new study, according to CNN.
Anita Brikman, senior vice president at Consumer Healthcare Products Association -a trade organization that represents over-the-counter drug manufacturers- said that the new study did not look at OTC products and that it only involved prescription proton-pump inhibitors, which are typically used at higher doses and for longer durations, she noted. Brikman added that this was an observational study so that no firm conclusions can be drawn from it.
Dr. Ihab Hajjar, an associate professor at the Emory University School of Medicine, said that while the new findings are concerning, it is important to note that PPIs users in general, including those involved in the study, are older and have more diseases. However, he stressed that it’s important for patients to regularly review all current medications with the prescribing providers, as sometimes they might be prescribed a medication that is unsuitable for them.