March 2, 2011 — Long-term use of prescription proton-pump inhibitors (PPIs) can be associated with hypomagnesemia, which can in turn cause serious muscle spasms (tetany), arrhythmias, and seizures, but may instead be asymptomatic, the US Food and Drug Administration (FDA) cautioned today.
The FDA recommends that clinicians consider checking serum magnesium levels before starting patients on PPIs for long-term therapy (generally 1 year or longer) and when the drugs will be coadministered with other agents that can cause low magnesium levels, such as diuretics or digoxin. For patients on digoxin, "this is especially important because low magnesium can increase the likelihood of serious side effects," the advisory says.
In addition, periodic monitoring of serum magnesium levels in at-risk patients is recommended.
In about 25% of cases reported to and reviewed by the FDA, magnesium supplementation alone was insufficient for correcting hypomagnesemia, and PPI therapy had to be discontinued.
The alert does not specify whether over-the-counter (OTC) formulations of PPIs have been associated with hypomagnesemia, but it does include a list of the products.
The drugs in question include esomeprazole magnesium (Nexium, AstraZeneca), dexlansoprazole (Dexilant, Takeda), omeprazole (Prilosec, Astra-Zeneca; also available OTC), omeprazole/sodium bicarbonate (Zergerid, AstraZeneca; also available OTC), lansoprazole (Prevacid, Novartis; also available OTC) pantoprazole soidum (Protonix, Wyeth/Pfizer; and generics) rabeprazole sodium (AcipHex, Eisai and Ortho-MacNeil), and esomeprazole magnesium/naproxen (Vimovo, AstraZeneca).
More information about today's announcement is available on the FDA Web site.
To report adverse events related to abacavir, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
The FDA recommends that clinicians consider checking serum magnesium levels before starting patients on PPIs for long-term therapy (generally 1 year or longer) and when the drugs will be coadministered with other agents that can cause low magnesium levels, such as diuretics or digoxin. For patients on digoxin, "this is especially important because low magnesium can increase the likelihood of serious side effects," the advisory says.
In addition, periodic monitoring of serum magnesium levels in at-risk patients is recommended.
In about 25% of cases reported to and reviewed by the FDA, magnesium supplementation alone was insufficient for correcting hypomagnesemia, and PPI therapy had to be discontinued.
The alert does not specify whether over-the-counter (OTC) formulations of PPIs have been associated with hypomagnesemia, but it does include a list of the products.
The drugs in question include esomeprazole magnesium (Nexium, AstraZeneca), dexlansoprazole (Dexilant, Takeda), omeprazole (Prilosec, Astra-Zeneca; also available OTC), omeprazole/sodium bicarbonate (Zergerid, AstraZeneca; also available OTC), lansoprazole (Prevacid, Novartis; also available OTC) pantoprazole soidum (Protonix, Wyeth/Pfizer; and generics) rabeprazole sodium (AcipHex, Eisai and Ortho-MacNeil), and esomeprazole magnesium/naproxen (Vimovo, AstraZeneca).
More information about today's announcement is available on the FDA Web site.
To report adverse events related to abacavir, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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