Safety Alerts & Recalls

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FDA Completes Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury
According to the U.S. Food and Drug Administration (FDA), people who take Xenical or Alli need to be aware of the rare occurrence of severe liver injury reported in some individuals who take these weight-loss drugs. The active ingredient in both of these drugs is orlistat. Xenical (orlistat 120 mg) is a prescription product. Alli (orlistat 60 mg) is sold over-the-counter (OTC) without a prescription. The FDA has approved a revised label for Xenical to include this new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The FDA is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning. For more information form the FDA about orlistat and severe liver injury, please visit: FDA's Consumer Update - http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213401.htm FDA's Questions and Answers - http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213040.htm FDA's Complete Safety Announcement - http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm
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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
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Date Published Title Drug Source
2010-05-27 FDA Completes Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury Orlistat FDA
2010-05-26 FDA Updates Prescribing Information for Proton Pump Inhibitors to Warn About Increased Risk of Fractures Dexlansoprazole FDA
2010-05-25 Ultram and Ultracet Prescribing Information Updated Tramadol FDA
2010-05-12 Serious Side Effects from Swallowing Topical Benadryl Product Diphenhydramine FDA
2010-05-12 Nycomed Recalls Several Different Eye Ointments Maxitrol FDA
2010-05-12 Diflorasone Cream: Nycomed Recalls Two Lots Diflorasone FDA
2010-05-12 Proton Pump Inhibitors (PPIs) May Be Linked to Bone Fractures and Bacterial Infections Omeprazole MediGuard CRT
2010-05-10 Voluntary Recall of Certain Lots of Claritin Eye Drops Ketotifen Manufacturer
2010-05-06 What Consumers Need to Know About Recalled Liquid Products for Children Cetirizine Manufacturer
2010-05-04 Medication Guide Reviews Risks of Vivitrol Naltrexone Manufacturer
2010-05-03 FDA Announces Ongoing Safety Review of Gonadotropin-Releasing Hormone (GnRH) Agonists Lupron FDA
2010-05-03 Voluntary Recall of Certain Liquid Children's and Infants' Tylenol Motrin, Zyrtec, and Benadryl Products Cetirizine Manufacturer
2010-04-26 Metoprolol: Ipca Laboratories Recalls Single Lot of Metoprolol Tartrate 50 mg Tablets Metoprolol FDA
2010-04-26 DIgoxin: West-ward Recalls Single Lot of Digoxin 125 mcg (0.125 mg) Tablets Digoxin FDA
2010-04-21 Propylthiouracil: FDA Requires Addition of Boxed Warning About Reports of Severe Liver Injury Propylthiouracil FDA
2010-04-20 Triclosan: FDA Publishes Questions and Answers Guide Triclosan FDA
2010-04-20 Risperidone: Dr. Reddy's Recalls Several Lots Risperidone FDA
2010-04-20 Glycopyrrolate: Corepharma LLC Issues Recall Glycopyrrolate FDA
2010-04-20 Apotex Recalls One Lot of Fluticasone Nasal Spray Fluticasone Nasal FDA
2010-04-20 Apotex Recalls Two Lots of Ipratropium Nasal Solution Ipratropium FDA