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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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Date Published Title Drug Source
2011-03-02 FDA Warns: Low Magnesium Levels Can Be Associated With Long-Term Use of Prescription Proton Pump Inhibitors Dexlansoprazole FDA
2011-03-01 FDA Review of Abacavir Finds No Increased Risk of Heart Attack Abacavir with Lamivudine FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone Topical FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone FDA
2011-02-25 Recall of Certain Lots of SUDAFED 24 Hour Pseudoephedrine Manufacturer
2011-02-24 Roche Announces Recall of ACCU-CHEK FlexLink Plus Infusion Sets Insulin Aspart FDA
2011-02-24 Upsher-Smith Expands Recent Recall to Include: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin Oxybutynin FDA
2011-02-24 Upsher-Smith Expands Recall of Jantoven to Include More Tablet Strengths and Other Products Oxybutynin FDA
2011-02-22 Labeling Change for all Antipsychotic Medications: Warnings Regarding Use During Pregnancy Moban FDA
2011-02-18 Upsher-Smith Announces Nationwide Recall Of Jantoven Warfarin Sodium Tablets, 3mg, Due To Mislabeled Bottles Warfarin FDA
2011-02-18 Terbutaline: Change To the Prescribing Information - Boxed Warning Against Use for Treatment of Preterm Labor Terbutaline FDA
2011-02-17 Janssen Recalls 10 Lots of Invega Sustenna Syringes Paliperidone FDA
2011-02-07 Watson Informs Customers of Important Information About Alcohol Prep Pads in Trelstar Kits Triptorelin FDA
2011-02-07 Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because of Incorrect Package Labeling Hydrocodone with Acetaminophen FDA
2011-02-07 Qualitest Recalls Phenobarbital Tablets Because of Incorrect Package Labeling Phenobarbital FDA
2011-02-04 FDA Update: Avandia, Avandamet and Avandaryl Labels Now Include Information About Heart-Related Risks, Patient Access Restrictions Expected Later This Year Glimepiride and Rosiglitazone FDA
2011-02-03 Lundbeck Inc. No Longer To Make Mebaral FDA
2011-02-01 Novartis Informs Customers of Important Information About Alcohol Prep Pads Packaged With Extavia Interferon beta-1b Kit FDA
2011-01-31 GSK Informs Customers of Important Information About Alcohol Prep Pads in Arixtra Starter Kits Fondaparinux FDA
2011-01-26 Pfizer Informs Customers of Important Information About Alcohol Prep Pads in Relistor Kits Methylnaltrexone FDA
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