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FDA Updates Prescribing Information for Blood Pressure Medicine Olmesartan to Include Link to Intestinal Problems (Sprue-Like Enteropathy)
The U.S. Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause an intestinal problem known as sprue-like enteropathy. The FDA identified this safety issue after reviewing adverse event reports identified in the FDA’s Adverse Event Reporting System (FAERS), published literature case series, information from FDA’s Mini-Sentinel pilot of the Sentinel Initiative, and information from the CMS Medicare database. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization. In the identified case-reports, stopping the olmesartan resulted in improvement of the sprue-like enteropathy symptoms in all patients. Olmesartan is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm359477.htm
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One Lot of Rugby Labeled Enteric Coated Aspirin 81 mg Tablets Recalled - May Contain Acetaminophen 500 mg Tablets
Advance Pharmaceutical Inc. is conducting a voluntary nationwide recall to the customer level of a single lot of the over-the-counter drug, Rugby label Enteric Coated Aspirin Tablets, 81 mg. Lot 13A026 is being recalled due to a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, which actually contains Acetaminophen 500 mg Tablets. The recalled product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablets with the following codes: NDC 0536-3086-41 and UPC 3 0536-3086-41 9. Consumers who take Rugby label Enteric Coated Aspirin Tablets, 81 mg from lot 13A026 may be unknowingly taking acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg. This may cause severe liver damage to people in any of the following categories: --- Those who take other drugs containing acetaminophen. --- Those who drink 3 or more alcoholic drinks per day. --- Those who have liver disease. The labeled directions for this recalled product instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 4-8 tablets daily of the defective product may be ingesting up to 24,000 mg of acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg). For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm357924.htm?source=govdelivery
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Date Published Title Drug Source
2013-07-03 FDA Updates Prescribing Information for Blood Pressure Medicine Olmesartan to Include Link to Intestinal Problems (Sprue-Like Enteropathy) Hydrochlorothiazide, Amlodipine, and Olmesartan FDA
2013-06-20 One Lot of Rugby Labeled Enteric Coated Aspirin 81 mg Tablets Recalled - May Contain Acetaminophen 500 mg Tablets Aspirin FDA
2013-06-19 FDA Investigates Reports of Two Deaths Following Injections of Zyprexa Relprevv (Olanzapine Pamoate) Olanzapine FDA
2013-06-13 Zydus Pharmaceuticals Recalls One Lot of Warfarin 2 mg Tablets Warfarin FDA
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer Ipratropium FDA
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer and Asthmanefrin Starter Kit FDA
2013-05-29 The Last of the CFC-Containing Inhalers To Be Taken Off the Market Maxair FDA
2013-05-29 L. Perrigo Co. Recalls Select Lots of Liothyronine Sodium Tablets, 5 mcg Liothyronine FDA
2013-05-24 Physicians Total Care Recalls Single Lot of Plavix 75 mg Clopidogrel FDA
2013-05-24 Recall of Levoxyl Produces Medication Shortage Levothyroxine Manufacturer
2013-05-07 FDA Warns Pregnant Women to Not Use Certain Migraine Prevention Medicines Divalproex Sodium FDA
2013-05-01 FDA Updates Prescribing Information for Samsca: Limits Use Tolvaptan FDA
2013-04-29 Anti-Seizure Medicine Potiga (Ezogabine) Linked to Eye Problems and Blue Skin Discoloration Ezogabine FDA
2013-04-26 Saratoga Therapeutics, LLC Recalls ebA Multivitamin Supplement Due to Undeclared Milk Components Multivitamin FDA
2013-04-19 One Touch Verio IQ and FreeStyle lnsulinx Blood Glucose Meters Recalled Insulin Lispro and Insulin Lispro Protamine FDA
2013-04-01 FDA Allows Changes to the Warnings and Directions for Use of Nicotine Patches, Gum, and Lozenges Nicotine FDA
2013-03-15 FDA Studies Possible Pancreatic Risk With Class of Diabetes Drugs Sitagliptin FDA
2013-03-12 FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax) Azithromycin FDA
2013-02-25 Affymax and Takeda Announce a Recall of All Lots of Omontys (Peginesatide) Injection Peginesatide Manufacturer
2013-02-03 Novartis Recalls Several Lots of Triaminic® and Theraflu Warming Relief® Syrups Manufacturer
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