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Over-the-Counter Heartburn Drugs Don’t Need U.S. Warnings

Over-the-counter heartburn drugs such as Procter & Gamble Co.’s Prilosec and Novartis AG’s Prevacid don’t increase the risk of broken bones, U.S. regulators said, reversing a decision announced a year ago.

Short-term use of low-dose proton pump inhibitors sold without a prescription “is unlikely” to lead to hip, wrist and spine fractures, the Food and Drug Administration said today. The agency said in May that over-the-counter and prescription heartburn drugs would need new warnings about broken bones.

Patients at highest risk for fractures took high doses of prescription heartburn and acid-reflux treatments or used the drugs for at least a year, the FDA said today. Over-the-counter versions are intended for 14-day use up to three times a year and the risks may increase if these medicines are taken more often.

“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 notice.

Novartis, of Basel, Switzerland, sells Prevacid over the counter under a license from Takeda Pharmaceutical Co., of Osaka, Japan. Prilosec, sold by Cincinnati-based P&G, contains a chemical similar to the key ingredient in Nexium, the leading prescription heartburn drug sold by London-based AstraZeneca Plc.

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