FDA Warns of Increased Fracture Risk with Antacid Drugs

Washington, DCThe FDA is warning of a possible increase in the risk for fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers.

The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. They are available both as prescription and as over-the-counter (OTC) medications.

The prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. The PPIs available over-the-counter are used to treat frequent heartburn.

The prescription PPIs are:

Nexium
Dexilant
Prilosec
Zegerid
Prevacid
Protonix
Aciphex
Vimovo

The over-the-counter PPIs are

Prilosec OTC (omeprazole)
Zegerid OTC (omeprazole)
Prevacid 24HR (lansoprazole)

The FDA action is based on a review of seven published studies, six of which reported an increased risk of fractures of the hip, wrist, and spine with the use of PPIs. Based on the available data, it is not clear at this time if the use of PPIs is the cause of the increased risk of fractures seen in some studies. Most of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture was seen mainly in this age group.