Heartburn Meds May Cause Bone Fractures

The FDA issued a warning about a possible increased risk of hip, wrist, and spinal fractures with high doses or long-term use of proton pump inhibitors, and so product labeling will be changed. The products include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix and Aciphex. Over-the-counter versions include Prilosec OTC, Zegerid OTC and Prevacid 24HR. “Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” Joyce Korvick, deputy director for safety in the FDAs Division of Gastroenterology Products, says in a statement. Most of the studies evaluated people 50 years or older, and the increased risk of fracture primarily was observed in this age group (there's more info, including a table of epidemiologicalhere).

3 Comments

May 25, 2010 - 4:04pm

Very interesting post, Ed!

“...the exact mechanisms for an increased risk of fractures with proton pump inhibitor use are not known.”

“To further investigate this issue, the FDA plans to analyze data from several large, long-term, placebo-controlled clinical trials of bisphosphonates (drugs used to prevent fractures) to assess the risk of fractures in women at risk for osteoporosis-related fractures who used or did not use proton pump inhibitors.”

I wonder if GI absorption of dietary calcium is not affected by long term PPI treatment. Could it be something as simple as the pH effect in the upper GI tract? I hope that the prospective studies measure Vitamin D3, calcium, and magnesium levels! Many of us D3 deficient. D3 deficiency alone puts us at increased risk of fractures. Could the risk of fractures with long term PPI treatment be mitigated with Vitamin D3 supplementation, e.g. at 5,000 IU per day?

http://www.nutraingredients-usa.com/Research/Vitamin-D-deficiency-increases-hip-fracture-risk-researchers

http://jama.ama-assn.org/cgi/content/abstract/293/18/2257

May 25, 2010 - 4:23pm

Here are some links to Vitamin D deficiency, mineral absorption, and secondary hyperparathyroidism, which may be playing a role in this apparent association between fractures and PPI treatment.

http://en.wikipedia.org/wiki/Vitamin_D

http://content.nejm.org/cgi/content/short/317/9/532

http://www.vivo.colostate.edu/hbooks/pathphys/digestion/smallgut/absorb_minerals.html

http://edrv.endojournals.org/cgi/content/short/22/4/477