FDA: Prolonged PPI use may increase risk of bone fractures

SILVER SPRING, Md. Prolonged use of a common class of drugs for treating digestive problems may increase the risk of bone fractures, the Food and Drug Administration said Tuesday.

The FDA issued a warning to consumers and healthcare professionals based on a review of several epidemiological studies that long-term use of prescription and OTC proton-pump inhibitors or use of the drugs in high doses could increase the risk of fractures of the hip, wrist and spine. Information about the possible risks will be included on revised product labels for PPIs, the FDA said.

“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton-pump inhibitors for one year or longer, or at high doses,” FDA division of gastroenterology products deputy director for safety Joyce Korvick said. “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, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”

PPIs are used to great gastroesophageal reflux disease, ulcers, esophageal inflammation and heartburn. Prescription PPIs include AstraZeneca’s Nexium, which IMS Health ranks as one of the top-selling drugs in the world, with 2009 sales of $6.3 billion, and Takeda’s Dexilant (dexlansoprazole). OTC PPIs Prilosec OTC (omeprazole), marketed by Procter & Gamble, and Prevacid 24HR (lansoprazole), marketed by Novartis, under licenses from AstraZeneca and Takeda, respectively.

AstraZeneca spokesman Blair Hains told Drug Store News the company recently had received the notice from the FDA and would respond within the allotted 30 days.

“We’re all working toward the same thing,” Hains said. “We want prescribers and patients to have the best healthcare information that’s out there.”