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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.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm245011.htm
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FDA Review of Abacavir Finds No Increased Risk of Heart Attack
The Food and Drug Administration (FDA) updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack (also known as myocardial infarction or MI) seen in some research studies, but not in others. The FDA reviewed 26 randomized clinical trials, and did not find an increased risk of heart attack associated with the use of abacavir. The FDA will continue to communicate any new safety information to the public as it becomes available.
Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection. Abacavir is sold under the brand name Ziagen and is also sold in combination with other antiretroviral drugs under the names Trizivir and Epzicom.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm245164.htm
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