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
