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According to an update provide by federal drug regulators this week, the risk of bone fractures from Nexium, Prilosec, Prevacid and other heartburn drugs only applies to prescription strength versions of these drugs, as patients at the highest risk for fractures received high-doses or used the medications for more than a year.
The FDA issued an update to an earlier drug safety communication yesterday, indicating that it has determined that use of high doses of a class of drugs known as proton pump inhibitors (PPIs) for more than a year can increase the risk of osteoporosis and fractures of the hip, wrist and spine.
The agency’s findings mean that a warning added last year to prescription-strength PPIs will not be needed for the over-the-counter (OTC) versions of the drugs.
The OTC versions of the drugs are at much lower doses than the prescription strength versions. They also are only intended for 14-day treatments up to three times per year. FDA officials said they are aware that some consumers may take the OTC heartburn drugs for longer periods of time than recommended and said healthcare professionals should be aware of the fracture risk if making such a recommendation to their patients.
The FDA first announced in May 2010 that warnings would be provided about the risk of bone fracture side effects from the heartburn drugs, but warnings were only indicated for prescription strength versions. Drugs affected by the labeling changes included prescription strength Nexium, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo.
The warnings came after FDA drug safety reviewers looked at a number of epidemiological studies into PPI bone fracture risks.
The prescription drugs pull in about $14 billion in U.S. sales each year, and many are prescribed for indigestion and heart burn, although with the exception of Prilosec, they are only approved for treatment of ulcers, acid reflux disease and erosive esophagitis. There were about 119 million prescriptions for proton pump inhibitors in the U.S. last year. Some medical experts estimate that as many as 69% of proton pump inhibitor prescriptions were written for “off-label” uses, which have not been approved as safe and effective by the FDA.