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Hypomagnesemia Linked to PPIs Can Cause Serious Adverse Effects
Docs Advised to Check Serum Magnesium Levels Before, During Treatment
By News Staff
In a March 2 safety announcement, the FDA said prolonged use -- longer than one year -- of the medications was associated with adverse events.
Eight prescription PPIs were included in the FDA's safety announcement:
- esomeprazole magnesium, which is marketed as Nexium;
- dexlansoprazole, which is marketed as Dexilant;
- omeprazole, which is marketed as Prilosec;
- omeprazole and sodium bicarbonate, which is marketed as Zegerid;
- lansoprazole, which is marketed as Prevacid;
- pantoprazole sodium, which is marketed as Protonix;
- rabeprazole sodium, which is marketed as AcipHex; and
- the combination drug naproxen and esomeprazole magnesium, which is marketed for arthritis relief as Vimovo.
OTC Proton Pump Inhibitors Safe When Used Correctly, Says FDA
Available OTC versions of PPIs include:
- omeprazole, which is marketed as Prilosec OTC;
- omeprazole and sodium bicarbonate, which is marketed as Zegerid OTC; and
- lansoprazole, which is marketed as Prevacid 24HR.
The FDA said checking serum magnesium levels was particularly important in patients taking the heart medication digoxin because low magnesium can increase the likelihood of serious side effects associated with that drug.
Magnesium supplements can be used to treat hypomagnesemia. However, patients who develop the condition may need to discontinue PPI therapy in addition to supplementing their magnesium levels. In one-fourth of the cases reviewed by the FDA, supplementation alone did not improve low serum magnesium levels.
The agency issued the following information for physicians:
- Advise patients to seek immediate medical care if they experience signs of hypomagnesemia, including arrhythmias, tetany, tremors or seizures, while taking PPIs. In children, arrhythmias may cause fatigue, upset stomach, dizziness and lightheadedness.
- Consider PPIs as a possible cause of hypomagnesemia, particularly in patients who are clinically symptomatic.
- OTC versions of the drugs are marketed at lower doses and are intended for a 14-day course of treatment as many as three times per year. However, physicians should be aware that consumers may take OTC PPIs for periods of time that exceed directions on OTC labels. Physicians who recommend prolonged use of an OTC product should tell patients about the risk of hypomagnesemia.
- Report adverse events involving PPIs to the FDA's MedWatch program.
FDA Issues Warning About Proton Pump Inhibitors
Studies Show Link Between PPI Use, Increased Fracture Risk, Other Adverse Effects
FDA Advises Against Use of Clopidogrel With Omeprazole, Other Drugs
Drug Interaction Reduces Effect of Anticlotting Medication
FDA Drug Safety Communication: "Low magnesium levels can be associated with long-term use of proton pump inhibitor drugs (PPIs)"
(March 2, 2011)