FDA warns of potential increase in fracture risk with PPI use, requires product label revisions

Using proton pump inhibitors (PPIs) for a long-term period or at high doses could increase the risk of certain fractures, according to a warning issued by the Food and Drug Administration. The agency is requiring manufacturers of drugs in this class to revise product labels to reflect this new information. The warning applies to prescription PPI products, including esomeprazole magnesium, omeprazole, lansoprazole, dexlansoprazole, pantoprazole sodium, omeprazole/sodium bicarbonate,...

Using proton pump inhibitors (PPIs) for a long-term period or at high doses could increase the risk of certain fractures, according to a warning issued by the Food and Drug Administration. The agency is requiring manufacturers of drugs in this class to revise product labels to reflect this new information.

The warning applies to prescription PPI products, including esomeprazole magnesium, omeprazole, lansoprazole, dexlansoprazole, pantoprazole sodium, omeprazole/sodium bicarbonate, and rabeprazole sodium, among others, as well as over-the-counter (OTC) PPIs, including OTC formulations of omeprazole and lansoprazole.

The regulatory agency said the warning was based on a review of 7 epidemiological studies; in 6 of the studies, an increased risk of fractures of the hip, wrist, and/or spine was reported in patients using PPIs. Results from 2 of the studies suggested that a greater risk of fractures was observed among participants who received high doses of the agents. The FDA also noted that data from 2 of the studies demonstrated an increase in fractures when PPIs were used for a longer duration.

The increased risk in fractures was observed primarily in patients aged 50 years or older, as the majority of the studies reviewed included patients in this age group.

The FDA advised health care professionals to consider implementing treatment at a lower dose or for a shorter duration and to monitor bone status in individuals at risk for osteoporosis.

"At the present time, there is uncertainty about the magnitude of this risk," the agency noted.

The FDA is planning to analyze data from several large, long-term, placebo-controlled clinical trials of bisphosphonates to assess the risk of fractures in women at risk for osteoporosis-related fractures who did or did not use PPIs.