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FDA Approves Warning Labels for OTC Heartburn Medications


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FDA Approves Warning Labels for OTC Heartburn Medications

The United States Food and Drug Administration has confirmed that major over-the-counter heartburn medications, including Nexium, Prevacid and Prilosec, will have warning labels.

Use of these products increases a consumers' risk of bone fractures. New labels will warn that the proton pump inhibitors must be used carefully, as high doses increase the risk of hip, spine and wrist injuries.

"Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition," said Dr. Joyce Korvick, deputy director of the division of gastroenterology products.

Korvick explained that epidemiology studies suggest that consumers who use proton pump inhibitors for a year or longer, or at high doses, may may be at increased risk for bone fractures.

Proton pump inhibitors help block the formation of stomach acid, which causes heartburn.