The FDA has determined that osteoporosis and fracture warnings are not needed on the labels of OTC proton pump inhibitors (PPIs), which are widely used to combat gastroesophageal reflux disease (GERD).
Last year, the FDA announced plans to revise the labels of OTC and prescription PPIs to reflect a possible increased risk of fractures of the hip, wrist, and spine.
However, “Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low-dose PPI use is unlikely,” the agency has now declared.
OTC PPIs are marketed at low doses and are only supposed to be used for 14-day periods up to three times per year. The FDA’s evaluation demonstrated that the patients at greatest risk for fractures received high doses of prescription PPIs and/or used such an agent for at least a year. The agency did caution, however, that clinicians should be aware of the risk for fracture if they are recommending use of the OTC products for longer periods of time than specified on the label.
The FDA also recently cautioned that prescription PPIs may cause low serum magnesium levels if taken for prolonged periods of time (in most cases, longer than one year). In approximately 25% of the cases reviewed by the agency, magnesium supplementation alone could not overcome the hypomagnesemia, and the patient had to stop using the PPI.