The warning about an increased risk of osteoporosis and fractures associated with proton pump inhibitors does not apply to over-the-counter formulations, the Food and Drug Administration announced March 23.
“Following a thorough review of available safety data, [the] FDA has concluded that fracture risk with short-term, low-dose PPI [proton pump inhibitor] use is unlikely,” the agency said in a statement. However, the statement pointed out that health care professionals “should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label.”
The statement is a follow-up to an announcement the FDA made in May 2010, which said that the labels for OTC and prescription PPIs were being revised to include new information about the “possible” increases in the risk of hip, wrist, and spinal fractures associated with the use of these medications. The revision was based on an FDA review of several epidemiologic studies that reported an increased risk of these fractures with PPI use and indicated that treatment with high doses for 1 or more years was associated with the greatest risk.
But in the new statement, the FDA said that the available data show that patients at the greatest risk for fractures were treated with high doses of prescription PPIs, which are at doses higher than OTC PPI doses, and/or used a PPI for 1 or more years.
OTC PPIs in the United States are marketed as Prilosec OTC, Zegerid OTC, and Prevacid24HR.
Adverse reactions associated with PPIs should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch.