Safety Alerts & Recalls

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FDA Early Communication About Ongoing Safety Review of Exjade
The FDA is reviewing safety issues with Exjade (desferasirox). Exjade has known adverse drug events, including kidney and liver failure, gastrointestinal ulcers and/or hemorrhage (bleeding). New safety data suggests there may be a greater number of these adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). MDS is a collection of disorders in which the bone marrow does not function normally and the body does not make enough normal blood cells (this can result in anemia, or low red blood cell counts). Patients with MDS and other chronic anemias may need many blood transfusions to treat the anemia. Receiving multiple blood transfusions can cause "iron overload" in patients (too much iron in the body). Exjade is an oral medication used to treat iron overload caused by receiving blood transfusions. Because the patients' advanced age, the seriousness of their disease, other medical disorders they may have and their need for blood transfusions may contribute to these reported adverse events, it is difficult for the FDA to draw conclusions without further analysis. The FDA's analysis of the available information is ongoing and the FDA will follow up with additional information once the review is complete. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183651.htm
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Voluntary Recall of Several Children's and Infants' Tylenol Products
McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' Tylenol liquid products that were manufactured between April, 2008 and June, 2008. The company is carrying out this recall because during this period, an unused portion of one inactive ingredient contained bacteria and did not meet all quality standards. Although no bacteria has been detected in the finished products and the finished products have met all standards, McNeil decided to recall all Children's and Infants' Tylenol liquid products which were made during this time. Tylenol is a medication that contains the active ingredient acetaminophen and is used to treat pain and fevers. These recall actions do not apply to Children's Tylenol Meltaways and Junior Strength Tylenol Meltaways or any other branded or generic acetaminophen product. The voluntary recall applies only to the select lots of Children's and Infants' TYLENOL liquid products listed below: SBM041, SBM067, SCM037, SDM027, SEM109 - Children's Tylenol Plus Cold MS Suspension 4 oz. Grape SBM042, SCM015, SCM036, SDM034 - Children's Tylenol Suspension 4oz. Grape SBM043, SBM044, SCM029 Children's - Tylenol Suspension 4oz. Bubble Gum SBM045, SCM011, SCM030, SDM035 - Children's Tylenol Suspension 4oz. Strawberry SBM064, SCM033, SDM020 - Infant's Tylenol Grape Suspension Drops 1/4oz. SBM065, SCM005, SCM006, SDM032 - Infant's Tylenol Suspension 1/2oz. Cherry SBM066, SCM068 - Children's Dye Free Suspension 4oz. Cherry SBM068, SCM035, SCM070, SCM080, SDM005 - Children's Tylenol Suspension 4oz. Cherry SBM069, SBM070, SCM081, SDM006 - Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry SCM012, SCM067, SDM007, SDM068 - Infant's Tylenol Suspension Drops 1/2oz. Grape SCM013, SCM014, SCM069 - Children's Tylenol Plus Flu 4oz. Bubble Gum SCM016, SFM024 - Children's Tylenol Plus Cold Suspension 4oz. Grape SCM017 - Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry SCM082, SDM039, SDM040 - Infant's Tylenol Suspension Drops 1oz. Grape SCM083, SCM084, SDM008 - Infant's Tylenol Dye Free Suspension 1oz. Cherry SDM064 - Children's Tylenol Pediatric Suspension 1oz. Cherry SDM038, SDM009 - Infant's Tylenol Suspension Drops 1oz. Cherry SDM033 - Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum SDM078 - Infant's Tylenol Drops 1oz. Grape SCM034 - Infant's Tylenol Grape Suspension Drops H/G 1/2oz. SDM028 - Children's Tylenol Suspension 4oz. Cherry, Hospital Govt. For more information please visit: http://www.tylenol.com/page.jhtml?id=tylenol/news/subpchildinfantnews.inc and http://www.tylenolprofessional.com/assets/TYLENOL_Letter_091809.pdf and http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183899.htm
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Date Published Title Drug Source
2009-09-28 FDA Early Communication About Ongoing Safety Review of Exjade Deferasirox FDA
2009-09-25 Voluntary Recall of Several Children's and Infants' Tylenol Products Acetaminophen Manufacturer
2009-09-25 Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors Oseltamivir FDA
2009-09-25 New Information About Reports of Acute Pancreatitis in Patients Using Sitagliptan (Januvia, Janumet) Sitagliptin FDA
2009-09-25 New Information About Reports of Acute Pancreatitis in Patients Using Sitagliptan (Januvia, Janumet) Metformin and Sitagliptin FDA
2009-09-17 FDA Requires Black Box Warning for Injection Form of Promethazine Promethazine FDA
2009-09-17 Update on Risk of Progressive Multifocal Leukoencephalopathy (PML) in Tysabri Patients Natalizumab FDA
2009-09-17 Several Lots of Albuterol Sulfate Inhalation Solution, 0.083% Reported Stolen Albuterol Manufacturer
2009-09-17 Three Lots of Ipratropium Bromide Inhalation Solution, 0.02% Reported Stolen Ipratropium Manufacturer
2009-09-16 Low-Dose Aspirin For Prevention Has Fewer Side Effects Than Higher Doses of Aspirin Clopidogrel MediGuard CRT
2009-09-16 Low-Dose Aspirin For Prevention Has Fewer Side Effects Than Higher Doses of Aspirin Ticlopidine MediGuard CRT
2009-09-16 Proton Pump Inhibitors (PPIs) in Healthy Patients May Cause Rebound Heartburn Symptoms Omeprazole MediGuard CRT
2009-09-16 Study Supports Link Between Pitavastatin MediGuard CRT
2009-09-14 Thiazolidinediones Associated with Increased Risk of Fractures Glimepiride and Rosiglitazone MediGuard CRT
2009-09-14 Important Information About Digoxin (Lanoxin) Digoxin MediGuard CRT
2009-09-04 Safety Information Added to the Myfortic Prescribing Information Mycophenolic Acid Manufacturer
2009-08-28 Rivistigmine (Exelon) Linked to Increased Risk of Fainting and Low Heart Rate Exelon MediGuard CRT
2009-08-28 Study Supports Link Between Statins and Muscle Pain and Weakness Atorvastatin MediGuard CRT
2009-08-28 Study Supports Link Between Statins and Muscle Pain and Weakness Fluvastatin MediGuard CRT
2009-08-28 Study Supports Link Between Statins and Muscle Pain and Weakness Lovastatin MediGuard CRT
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