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FDA Issues Warning About PPI Antacids and Broken Bones, Product Labeling to Change

By Paul Napoli

Results of recent studies linking popular Proton pump inhibitors (PPIs) to broken bones have prompted the U.S. Food and Drug Administration (FDA) to issue a warning today about the drugs and announce that manufacturers will change product labeling to warn of the risk.

The FDA wants consumers and healthcare professionals to be aware that high doses or long-term use of proton pump inhibitors may cause an increased risk of fractures of the hip, wrist and spine.

Proton pump inhibitors, available by prescription and over-the-counter (OTC), are a class of drug that reduces the production of stomach acid by blocking a certain enzyme in the stomach wall that produces acid.

Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus.

OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).

'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,' said Joyce Korvick, M.D., deputy director for safety in FDA's Division of Gastroenterology Products said in a news release. '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.'

The FDA did not specify which studies influenced the agency's decision, but a study linking PPI's to broken bones appeared in the May 10, 2010 issue of Archives of Internal Medicine.

'A staggering 113.4 million prescriptions for proton pump inhibitors (PPIs) are filled each year, making this class of drugs, at $13.9 billion in sales, the third highest seller in the United States,' wrote Mitchell H. Katz, MD, San Francisco Department of Public Health, San Francisco, CA in an editorial accompanying the study in the medical journal.

Katz says PPIs are over-prescribed, with between 53% and 69% of PPI prescriptions for inappropriate indications and suggests that risks associated with use of PPIs outweigh the benefits in many patients.

Consumers should report any side effects or other product problems with proton pump inhibitors to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on May 26, 2010 (boomark / email).