FDA Clears OTC Heartburn Drugs After Fracture Risk Found to Be Unlikely

The U.S. Food and Drug Administration (FDA) said over-the-counter heartburn drugs such as Prevacid and Prilosec do not appear to be associated with an increased chance of fractures and scrapped plans to update the drug labels to warn consumers of such a risk, The Wall Street Journal reported Thursday.

Last year, the agency claimed that proton pump inhibitors (PPIs), which suppress acid in the stomach, might be associated with an increased risk of hip, wrist and spine fractures and said new warnings would be placed on prescription and over-the-counter products.

However, the FDA said Wednesday that the increased fracture risk was unlikely with over-the-counter versions of the drugs, which use lower doses than prescription products. PPIs make up the third-biggest selling class of drugs in the US.

"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 posted on its website.

The agency said it recognized that consumers might take over-the-counter products for longer periods of time or at higher doses than stated on the label and said doctors should be aware of the fracture risk.

Prescription PPIs such as AstraZeneca's Nexium were meant to treat gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus. Drugs such as Prilosec, Zegerid and Prevacid are sold in over-the-counter versions for the treatment of frequent heartburn.

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