March 02, 2011
FDA Warns That PPIs May Cause HypomagnesemiaThe FDA has notified healthcare professionals and patients that prescription proton pump inhibitors may cause hypomagnesemia if taken for prolonged periods of time (in most cases, longer than one year). Hypomagnesemia can result in serious adverse events including tetany, arrhythmias, and seizures; however, patients do not always have these symptoms. Healthcare 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. For patients taking digoxin, healthcare professionals should periodically obtain magnesium levels.
PPIs are indicated to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prescription PPIs include Nexium (esomeprazole; AstraZeneca), Dexilant (dexlansoprazole; Takeda), Prilosec (omeprazole; AstraZeneca), Zegerid (omeprazole and sodium bicarbonate; Santarus), Prevacid (lansoprazole; Takeda), Protonix (pantoprazole; Pfizer), and AcipHex (rabeprazole sodium; PriCara). Vimovo is a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen; AstraZeneca).
Over-the-counter PPIs include Prilosec OTC (omeprazole; Procter & Gamble), Zegerid OTC (omeprazole and sodium bicarbonate; Merck), and Prevacid 24HR (lansoprazole; Novartis). Because OTC PPIs are marketed at low doses and are only intended for a 14-day course of treatment up to three times per year, the FDA believes that there is very little risk of hypomagnesemia when OTC PPIs are used according to the product label.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245275.htm.