viernes, 14 de agosto de 2015

FDA MedWatch - July 2015 Safety Labeling Changes includes 49 products with revisions to Prescribing Information

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch July 2015 Safety Labeling Changes posting includes 49 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections:
Aczone (dapsone topical gel) 5 % 
Agrylin (anagrelide hydrochloride) Capsules  
Aranesp (darbepoetin alfa) 
Aricept (donepezil HCl) Film Coated Tablet  
Aricept (donepezil HCl) Tablet
Aricept ODT (donepezil HCl) Tablet
Auryxia (ferric citrate) Tablets  
Ceftriaxone for Injection and Dextrose Injection, for Intravenous Use  
Cellcept (Mycophenolate Mofetil) Capsules
Cellcept (Mycophenolate Mofetil) HCL) Injection
Cellcept (Mycophenolate Mofetil) Oral Suspension  
Cellcept (Mycophenolate Mofetil) Tablets
Cholografin Meglumine (iodipamide meglumine) Injection
Cleocin Vaginal Cream
Cleocin Vaginal Ovules  
Conray (Iothalamate Meglumine) Injection
Conray 30 (Iothalamate Meglumine) Injection 
Conray 43 (Iothalamate Meglumine) Injection
Cystografin (diatrizoate meglumine) Injection
Cystografin Dilute (diatrizoate meglumine) Injection
Digoxin 0.05 mg/mL Oral Solution USP 
Diovan (valsartan) Capsules
Diovan (valsartan) Tablets
Diovan HCT (valsartan/hydrochlorothiazide) Tablets 
Droxia (hydroxyurea)
Dysport (abobotulinumtoxinA) Injection
Etopophos (etoposide phosphate) for Injection 
Evotaz (atazanavir/cobicistat) Tablets   
Exforge (amlodipine/valsartan) Tablets  
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets
Exjade (deferasirox) Tablets 
Eylea (aflibercept) Injection  
Gelnique (oxybutynin chloride), 10 percent gel  
Gelnique (oxybutynin chloride), 3 percent gel 
Gilenya (fingolimod) Capsules 
Hexabrix (ioxaglate meglumine 39.3%; ioxaglate sodium 19.6%) Injection
Isovue (iopamidol) Injection
Isovue (iopamidol) Injection Pharmacy Bulk Pack and Imaging Bulk Pack
Isovue-M (iopamidol) Injection
Jentadueto (linagliptin and metformin hydrochloride) Tablets 
Lanoxin (digoxin) Injection
Lanoxin (digoxin) Injection Pediatric 
Lanoxin (digoxin) Tablets
Lantus (insulin glargine injection)
Lexiva (fosamprenavir calcium) Tablets and Oral Solution   
Lotensin (benazepril) Tablets 
MD-76R (Diatrizoate Meglumine; Diatrizoate Sodium) Injection
Mycobutin (rifabutin) Capsules 
Neupogen (filgrastim) 
Omnipaque (iohexol) Injection
Omnipaque (iohexol) Injection Pharmacy Bulk Pack
Optiray (ioversol) Injection
Optiray (ioversol) Injection Pharmacy Bulk Package
Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablets  
Oxytrol (oxybutynin transdermal system) 
Plavix (clopidogrel bisulfate) Tablets 
Prinivil (lisinopril) Tablets 
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets 
Tradjenta (linagliptin) Tablets 
Ultravist (iopromide) Injection
Ultravist (iopromide) Injection Pharmacy Bulk Pack
Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Copackaged for Oral Use
Visipaque (iodixanol) Injection
Visipaque (iodixanol) Injection Pharmacy Bulk Pack
Vitekta (elvitegravir) Tablet 
Zmax (azithromycin extended release) for Oral Suspension 
Zykadia (ceritinib) Capsules 
Zyprex Intramuscular (olanzapine) 
Zyprexa (olanzapine) Tablets
Zyprexa Relprevv (olanzapine) For Extended Release Injectable Suspension 
Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets

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