PPIs get warning on fracture risk
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High doses or long-term use of proton-pump inhibitors may increase the risk of certain fractures, the FDA recently warned health care professionals and patients.
The labeling of both prescription and over-the-counter PPIs will be revised to reflect this risk, according to an FDA news release. The warning is based on an FDA review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist and spine in patients using PPIs.
Physicians should weigh the known benefits against the potential risks of proton-pump inhibitors when determining if these medications are appropriate for treatment, the FDA advised. “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 an FDA official.
Any side effects or other product problems with PPIs should be reported via the FDA's MedWatch Adverse Event Reporting program or by calling 800-332-1088.