MedWatch October 2013 Safety Labeling Changes

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The MedWatch October 2013 Safety Labeling Changes posting includes 68 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm373523.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:   

Actemra (tocilizumab) injection
Accupril (quinapril hydrochloride) Tablets
Accuretic (quinapril hydrochloride/HCTZ) Tablets
Altace (ramipril) Capsules     
Amaryl (glimepiride) tablets
Amerge (naratriptan hydrochloride) tablets    
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Climara (estradiol) transdermal system and Climara Pro (estradiol/levonorgestrel) transdermal system     
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets
Diabeta (glyburide) tablets
Diovan (valsartan) Capsules        
Entereg (alvimopan) Capsules
Eovist (gadoxetate disodium) Injection
Exelon (rivastigmine tartrate) capsules and oral solution  
Exjade (deferasirox) tablets, for oral suspension   
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
Gadavist (Gadobutrol) Injection  
Gleevec (imatinib mesylate) Tablets    
Glucovance (Glyburide and Metformin HCl) tablets  
Glucotrol (glipizide) tablets    
Glucotrol XL (glipizide) Extended Release tablets    
Glynase PresTab (micronized glyburide) tablets    
Incivek (telaprevir) tablets    
Isentress (raltegravir) film-coated tablets and chewable tablets    
Juvisync (sitagliptin phosphate and simvastatin) tablets   
Lantus (insulin glargine [rDNA origin] injection) solution    
Livalo (pitavastatin) Tablets    
Lopid (gemfibrozil) Capsules       
Lovenox (enoxaparin sodium) injection    
Lupron Depot (leuprolide acetate for depot suspension) and Lupaneta Pack (leuprolide acetate for depot suspension; norethindrone acetate) tablets
Lysteda (tranexamic acid) Tablets       
Magnevist (gadopentetate dimeglumine) Injection and Magnevist Pharmacy Bulk Package Injection         
Menostar (estradiol) transdermal system    
Metaglip (glipizide/metformin hydrochloride fixed-dose combination) tablets    
Micronase (glyburide) tablets     
Modicon (norethindrone/ethinyl estradiol)  
Monodox (doxycycline monohydrate) capsules      
Nizoral (ketoconazole) 2% shampoo  
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)     
Ofirmev (acetaminophen) Injection    
Ortho-Cept (desogestrel/ethinyl estradiol)     
Ortho-Cyclen (norgestimate/ethinyl estradiol)   
Ortho Novum (norethindrone/ethinyl estradiol)  
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)  
Relpax (eletriptan hydrobomide) tablets    
Revia (naltrexone HCl) tablets   
Savella (milnacipran HCl) Tablets    
Stribild (elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate) fixed dose combination tablets
Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets
Ultracet (tramadol HCl/acetaminophen) Tablets      
Viread (tenofovir disoproxil fumarate) tablets and oral powder
Vytorin (ezetimibe/simvastatin) Tablets
Xalkori (crizotinib) capsules    
Zaltrap (ziv-aflibercept) Injection   
Zocor (simvastatin) Tablets
Zuplenz (ondansetron) oral soluble film  

 

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