FDA lifts fracture warning on OTC stomach meds

Over-the-counter heartburn drugs don't need a new fracture-risk warning, the FDA says. When used at low doses and on a short-term basis, OTC versions of meds such as Prilosec and Prevacid don't appear to boost the risk of fractures, the agency said. But prescription-strength proton-pump inhibitors used over the long term still aren't in the clear.

"In contrast to prescription PPIs, [over-the-counter] PPIs are marketed at low doses and are only intended for a 14-day course of treatment up to three times per year," the FDA said in a statement. Patients may use the OTC products for longer periods--or even at higher doses--the agency said, so doctors should remain aware of the fracture risk associated with increased usage.

In May of last year, FDA warned that patients using high doses of prescription PPIs--such as Pfizer's Protonix, AstraZeneca's Nexium and Prilosec and Takeda Pharmaceuticals Prevacid--or taking the drugs for long periods of time may end up with an increased risk of hip, wrist and spinal fractures. That warning was based on the FDA's review of seven published studies, Reuters reports, with six of those showing an increased risk of fractures in those who used the drug, especially patients aged 50 years or older.

- read the announcement from the FDA
- see the Dow Jones story
- get more from Reuters

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