Side Effects of Nexium, Prilosec, Other PPIs May Increase Dementia Risk: Study

The findings of new research raises further concerns about the potential side effects of popular heartburn drugs, such as Nexium, Prilosec, Prevacid and others, suggesting that users may face an increased risk of experiencing dementia. 

In a study published this month in the medical journal JAMA Neurology, German researchers say that a class of widely used acid reflux drugs, known as proton pump inhibitors (PPIs), may significantly increase the dementia risk when the medications are used regularly.

PPIs are designed to reduce the amount of acid in the stomach, treating gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, and inflammation of the esophagus. Drugs that belong to the class include some of the biggest selling medications in the U.S., such as Nexium, Prevacid, Prilosec (and generic omeprazole), Protonix, AcipHex, Dexilant, Vimovo and Zegerid.

Prior to becoming available over-the-counter, prescription Nexium generated an estimated $6 billion in annual sales.

In this latest study, researchers conducted a prospective cohort study with observational data from a major German health insurer involving nearly 74,000 patients from 2004 to 2011. They looked at dementia rates among patients prescribed Nexium, Prilosec, Protonix, Prevacid, and AcipHex.

Researchers found that those who used these heartburn drugs regularly had a 44% increased risk of dementia incidents compared to those who did not use those medications. The mean age of the subjects was 83-84 years of age.

According to the researchers, similar findings were indicated in earlier mouse studies.

“The avoidance of PPI medication may prevent the development of dementia,” the researchers warned, while noting that they did not find a causal link between the drugs and the onset of dementia. “Randomized, prospective clinical trials are needed to examine this connection in more detail.”

Heart burn drugs have already been linked to a number of other potentially harmful side effects, and some consumer watchdog groups have even warned that they could be addictive. One of the most dramatic side effects are those of bone fractures.

In 2010, the FDA required the manufacturers of all other proton pump inhibitor (PPI) medications to update the warning labels, adding information about a potential risk of fractures and bone problems from side effects of Prilosec, Nexium and other drugs in the same class.

That warning was updated again by the FDA in 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time.  Lower dose, over-the-counter, versions of the drug did not appear to be affected, according to federal drug regulators.

A number of former users who have suffered bone fractures have pursued a Nexium lawsuit, alleging that AstraZeneca failed to adequately warn about the risks associated with long term use of the heartburn drug.