Safety Alerts & Recalls

What does this mean?

For most people, the benefits of prescription PPIs will continue to outweigh the risks. You should not stop taking your prescription PPI drug without talking to your healthcare professional. Because of this new safety information, your healthcare professional now may occasionally check your serum magnesium level (a blood test) while you are taking your prescription PPI drug. You should tell your healthcare professional if you have ever been told you have low magnesium levels in your blood, take the drug digoxin (Lanoxin), or are being treated with a diuretic such as furosemide (Lasix), bumetanide (Bumex), torsemide (Demadex), ethacrynic acid (Edecrin), chlorothiazide (Diuril), hydrochlorothiazide (Microzide, Oretic, plus many combination blood pressure pills), indapamide, and metolazone (Zaroxolyn). This safety alert is especially important for patients taking digoxin because low magnesium can increase the likelihood of serious side effects.

If you take an over-the-counter (OTC) PPI drug, follow the directions on the package carefully and make sure your healthcare professional knows if you have been taking an OTC PPI drug for longer than the recommended 14-day course.

While taking PPIs, you can watch for symptoms of low levels of magnesium in the blood such as abnormal heart rate or rhythm (including a racing heartbeat or palpitations), muscle spasm, tremor or convulsions. In children, abnormal heart rates may cause fatigue, upset stomach, dizziness and lightheadedness. Please seek immediate care if you (or your child) experience any of these symptoms.

If you have questions or concerns about your PPI drug, please discuss them with your healthcare professional. Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of PPIs to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Warns: Low Magnesium Levels Can Be Associated With Long-Term Use of Prescription Proton Pump Inhibitors

Today, the Food and Drug Association (FDA) notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) medicines may cause low levels of magnesium in the blood (hypomagnesemia) if taken for long periods of time (in most cases, longer than one year). Low magnesium levels in the blood can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements and may also require stopping the PPI. Information about the potential risk of low magnesium blood levels from PPIs will be added to the WARNINGS AND PRECAUTIONS sections of the labels for all the prescription PPIs.

PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), and AcipHex (rabeprazole sodium). Vimovo is a prescription combination drug product that contains a PPI (esomeprazole magnesium) and naproxen. Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).

In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14 day course of heartburn treatment up to 3 times per year. The FDA believes that there is very little risk of hypomagnesemia when OTC PPIs are used according to the directions on the OTC label.

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Source: FDA
Publication Date: 2011-03-02
Last Updated: 2011-03-03
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