Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

FDA Updates Prescribing Information for Proton Pump Inhibitors to Warn About Increased Risk of Fractures
The U.S. Food and Drug Adminstration (FDA) has announced there is a possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers. The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. This new safety information is based on the FDA's review of several studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use. The greatest increased risk for fractures in these studies involved people who had been taking prescription PPIs for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter). This FDA review included the Archives of Internal Medicine study described in the recent iGuard alert about this same safety issue. PPIs are available both as prescription and as over-the-counter (OTC) medications. The prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. The PPIs available over-the-counter are used to treat frequent heartburn. The prescription PPIs are esomeprazole (Nexium), dexlansoprazole (Dexilant), lansoprazole (Prevacid), omeprazole (Prilosec), omeprazole and sodium Bicarbonate (Zegerid), pantoprazole (Protonix), rabeprazole (Aciphex), and naproxen and esomeprazole (Vimovo). Prilosec OTC, Prevacid 24HR, and Zegerid OTC are sold over-the-counter (OTC) for the treatment of frequent heartburn. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213240.htm and http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm#TableofEpidemiologicalstudiesevaluatingfractureriskwithprotonpumpinhibitors
Learn More

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
Learn More

Date Published Title Drug Source
2010-05-26 FDA Updates Prescribing Information for Proton Pump Inhibitors to Warn About Increased Risk of Fractures Dexlansoprazole FDA
2011-03-02 FDA Warns: Low Magnesium Levels Can Be Associated With Long-Term Use of Prescription Proton Pump Inhibitors Dexlansoprazole FDA
2011-03-24 FDA Issues Update for Proton Pump Inhibitors and Risk of Fractures Dexlansoprazole FDA
2012-02-08 FDA Issues Safety Announcement: Proton Pump Inhibitors (PPIs) Possibly Associated with Clostridium Difficile-Associated Diarrhea (CDAD) Dexlansoprazole FDA
2009-06-15 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Dexmethylphenidate FDA
2013-12-17 FDA Warns of Rare Risk of Priapism Associated with Methylphenidate Products Dexmethylphenidate FDA
2008-10-16 Selected Recall of ETHEX Dextroamphetamine Sulfate 5 mg Tablets Dextroamphetamine Manufacturer
2008-11-10 Recall on Several Lots of Dextroamphetamine 10 mg Tablets Dextroamphetamine Manufacturer
2009-01-29 Recall on All ETHEX Brand Dextroamphetamine Tablets Dextroamphetamine Manufacturer
2009-06-15 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children Dextroamphetamine FDA
2008-10-10 Important Information About Safe Use of Children's Cough and Cold Medicine Dextromethorphan Manufacturer
2010-06-01 All Lots of Four Select PediaCare Products Recalled Dextromethorphan Manufacturer
2012-12-11 Proctor and Gamble Recalls Select Lots of Vicks NyQuil Cold & Flu, Nighttime Relief FDA
2012-05-23 McNeil Consumer Healthcare Recalls Imodium Manufacturer
2009-12-08 Safety Update to the Prescribing Information for Diclofenac Products Diclofenac FDA
2011-11-17 FDA Requests a Stop to the Distribution of Pennsaid Samples Diclofenac FDA
2013-08-30 Consumers Warned Not to Purchased Ortiga, an Unapproved Product Diclofenac FDA
2009-12-08 Safety Update to the Prescribing Information for Diclofenac Products Diclofenac Sodium with Misoprostol FDA
2012-07-22 Physicians Total Care, Inc Recalls Several Lots of Arthrotec 75 Diclofenac Sodium with Misoprostol FDA
2008-03-27 Potential increased risk of heart attack Didanosine FDA
Back to Consumer Med Safety