Unlike their prescription counterparts, over-the-counter (OTC) <"https://www.yourlawyer.com/topics/overview/Proton_pump_inhibitors">proton pump inhibitors, or PPIs, including Prevacid 24HR and Prilosec OTC, aren’t associated with a risk of fractures, according to the U.S. Food & Drug Administration (FDA). As such, the agency said it will not go forward with plans to update the labels of OTC proton pump inhibitors to warn consumers of a fracture risk.
Proton pump inhibitors work by reducing the amount of acid in the stomach, and are approved to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prescription versions of the drugs include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. OTC brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR.
Last year, the FDA said it would be changing the drugs’ labels to warn of a potential fracture risk after a review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group, the agency said.
But now the FDA is changing its tune on OTC proton pump inhibitors. In a statement on its website, the agency said:
“FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication â€œDrug Factsâ€ label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely.
The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.”
The statement goes on to point out that OTC proton pump inhibitors are marketed at low doses and are only intended for a 14 day course of treatment up to 3 times per year. Taking higher doses of OTC proton pump inhibitors, or taking them for extended periods of time, could still pose a fracture risk. Patients and healthcare providers “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 FDA said.