CORRECTED - UPDATE 2-No fracture warning needed for OTC ulcer drugs-FDA
(Corrects to delete inaccurate reference in paragraph 2 to FDA changing labels. This error also appeared in UPDATE 1. Rewrites headline, bullets and story to reflect that news is FDA conclusion that short-term, low-dose use of the drugs is unlikely to pose fracture risk. The finding of potential fracture risk with longer-term use was previously reported)
* Short-term, low-dose use unlikely to pose risk-U.S. FDA
* Agency had warned of risk from long-term, high-dose use
March 23 (Reuters) - Short-term, low-dose use of a popular group of ulcer drugs is unlikely to pose a risk of fractures, the U.S. Food and Drug Administration said on Wednesday.
The agency determined that a fracture warning for the over-the-counter versions of the drugs, known as proton pump inhibitors, is not warranted.
In May 2010, the FDA said that patients taking prescription versions of the drugs at high doses or for longer periods may have increased risk of fractures of the hip, wrist and spine.
Proton pump inhibitors (PPIs) are widely used to treat ulcers, acid reflux and other conditions.
Prescription PPIs include names such as AstraZeneca's (AZN.L) (AZN.N) Nexium, Prilosec and Vimovo, Takeda Pharmaceutical's (4502.T) Dexilant and Prevacid, Pfizer's (PFE.N) Protonix, Johnson & Johnson (JNJ.N) and Eisai's (4523.T) Aciphex and Santarus's SNTS.O Zegerid.
Prilosec, Zegerid and Prevacid are also available in over-the-counter versions.
The over-the-counter drugs 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 on its website.
The FDA said patients at highest risk for fractures received high doses of prescription PPIs -- higher than non-prescription versions -- and/or used the drug for at least a year.
"FDA acknowledges that consumers, either on their own, or based on a healthcare professional's recommendation, may take these products for periods of time that exceed the directions on the OTC label," the agency said.
In its May announcement, the FDA said it had reviewed seven published studies, six of which showed an increased risk of fractures with the use of the drugs.
Most of the studies tested individuals aged 50 years or older, and the increased risk of fracture was seen mainly in this age group. (Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier)
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