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FDA: Long-term proton pump inhibitor use linked with hypomagnesemia
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The FDA has issued a public safety communication warning that the long-term use of prescription proton pump inhibitors is potentially associated with low magnesium levels.
Citing a review of 38 cases from the Adverse Event Reporting System and 23 cases from medical literature, the agency determined there was an association between hypomagnesemia-related adverse events in adult patients who had been taking proton pump inhibitors (PPIs) for at least 3 months. Most of the events occurred after 1 year of taking PPIs, and approximately one quarter of the cases required the discontinuation of PPI treatment (as well as magnesium supplementation). The agency also noted that since hypomagnesemia is likely under-reported and under-recognized, available data was insufficient to quantify an incidence rate.
Among the clinically serious events reported in the review were tetany, seizures, tremors, carpo-pedal spasm, atrial fibrillation, supraventricular tachycardia and abnormal QT interval.
The FDA communication said that the mechanism responsible for the association was not known, and recommended that patients on PPIs exhibiting symptoms of hypomagnesemia first talk to their health care providers before discontinuing any prescription PPI regimens.
“Health care professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia,” the agency wrote in the announcement. “For patients taking digoxin, this is especially important because low magnesium levels increase the likelihood of serious side effects.”
The full FDA communication can be found here.
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