Drug Safety Labeling Changes - October 2013

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October 2013

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Entereg (alvimopan) CapsulesBoxed Warning-WarningsPrecautionsAdverse Reactions---
Lovenox (enoxaparin sodium) injectionBoxed Warning-WarningsPrecautions----
Modicon (norethindrone/ethinyl estradiol)Boxed WarningContraindicationsWarningsPrecautions----
Ofirmev (acetaminophen) InjectionBoxed Warning-WarningsPrecautions----
Ortho-Cept (desogestrel/ethinyl estradiol) Boxed WarningContraindicationsWarningsPrecautions----
Ortho-Cyclen (norgestimate/ethinyl estradiol)Boxed WarningContraindicationsWarningsPrecautions----
Ortho Novum (norethindrone/ethinyl estradiol)Boxed WarningContraindicationsWarningsPrecautions----
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)Boxed WarningContraindicationsWarningsPrecautions----
Amerge (naratriptan hydrochloride) tablets-ContraindicationsWarningsPrecautions----
Climara (estradiol) transdermal system and Climara Pro (estradiol/levonorgestrel) transdermal system-ContraindicationsWarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Diovan (valsartan) Capsules-ContraindicationsWarningsPrecautions----
Eovist (gadoxetate disodium) Injection-ContraindicationsWarningsPrecautions----
Exelon (rivastigmine tartrate) capsules and oral solution-ContraindicationsWarningsPrecautionsAdverse Reactions---
Gadavist (Gadobutrol) Injection-ContraindicationsWarningsPrecautions----
Glucovance (Glyburide and Metformin HCl) tablets-Contraindications-Precautions----
Glynase PresTab (micronized glyburide) tablets-Contraindications-Precautions----
Incivek (telaprevir) tablets-Contraindications-Precautions----
Lopid (gemfibrozil) Capsules-ContraindicationsWarningsPrecautions----
Lysteda (tranexamic acid) Tablets-ContraindicationsWarningsPrecautions----
Magnevist (gadopentetate dimeglumine) Injection and Magnevist Pharmacy Bulk Package Injection-Contraindications------
Drug Name BW C W P AR PPI MG PCI
Menostar (estradiol) transdermal system-ContraindicationsWarningsPrecautions----
Micronase (glyburide) tablets-Contraindications-Precautions----
Relpax (eletriptan hydrobomide) tablets-ContraindicationsWarningsPrecautions----
Revia (naltrexone HCl) tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Savella (milnacipran HCl) Tablets-ContraindicationsWarningsPrecautions----
Actemra (tocilizumab) injection--WarningsPrecautions----
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets--WarningsPrecautionsAdverse Reactions---
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets--WarningsPrecautionsAdverse Reactions---
Exjade (deferasirox) tablets, for oral suspension--WarningsPrecautionsAdverse Reactions---
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Juvisync (sitagliptin phosphate and simvastatin) tablets--WarningsPrecautions----
Lantus (insulin glargine [rDNA origin] injection) solution--WarningsPrecautions----
Livalo (pitavastatin) Tablets--WarningsPrecautions----
Lupron Depot (leuprolide acetate for depot suspension) and Lupaneta Pack (leuprolide acetate for depot suspension; norethindrone acetate tablets) --WarningsPrecautions----
Stribild (elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate) fixed dose combination tablets--WarningsPrecautionsAdverse Reactions---
Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets--WarningsPrecautionsAdverse Reactions---
Ultracet (tramadol HCl/acetaminophen) Tablets--Warnings-----
Viread (tenofovir disoproxil fumarate) tablets and oral powder--WarningsPrecautionsAdverse Reactions---
Xalkori (crizotinib) capsules --WarningsPrecautions----
Zaltrap (ziv-aflibercept) Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Accupril (quinapril hydrochloride) Tablets---Precautions----
Accuretic (quinapril hydrochloride/HCTZ) Tablets---Precautions----
Amaryl (glimepiride) tablets---Precautions----
Diabeta (glyburide) tablets---Precautions----
Glucotrol (glipizide) tablets---Precautions----
Glucotrol XL (glipizide) Extended Release tablets---Precautions----
Isentress (raltegravir) film-coated tablets and chewable tablets---Precautions----
Metaglip (glipizide/metformin hydrochloride fixed-dose combination) tablets---Precautions----
Monodox (doxycycline monohydrate) capsules---PrecautionsAdverse Reactions---
Nizoral (ketoconazole) 2% shampoo---Precautions----
Drug Name BW C W P AR PPI MG PCI
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension(albumin-bound))----Adverse Reactions---
Kineret (anakinra) for injection----Adverse Reactions---
Namenda (memantine hydrochloride) tablets----Adverse Reactions---
Nexavar (sorafenib tosylate) tablets----Adverse Reactions---
Nucynta (tapentadol) immediate-release tablets----Adverse Reactions---
Sabril (vigabatrin) tablet and powder for oral solution----Adverse Reactions---
Seroquel (quetiapine fumarate) tablets----Adverse Reactions---
Seroquel XR (quetiapine fumarate) Extended-Release tablet----Adverse Reactions---
Uvadex (methoxsalen) Sterile Solution----Adverse Reactions---
Valium (diazepam) Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Vesicare (solifenacin succinate) tablets----Adverse Reactions---
Xenical (orlistat) capsules---PrecautionsAdverse Reactions---
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