Drug Safety Labeling Changes - July 2014

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July 2014

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
Arixtra (fondaparinux sodium) Solution for InjectionBoxed Warning-WarningsPrecautions----
Linzess (linaclotide) capsulesBoxed WarningContraindicationsWarningsPrecautions----
Afinitor (everolimus) tablets for oral administration--WarningsPrecautionsAdverse Reactions---
Afinitor Disperz (everolimus tablets for oral suspension)--WarningsPrecautionsAdverse Reactions---
Anafranil (clomipramine) Capsules--WarningsPrecautionsAdverse Reactions---
Aptryxol (desvenlafaxine) extended-release Tablets --WarningsPrecautionsAdverse Reactions---
Aristocort Forte (Triamcinolone Diacetate, USP) Injectable Suspension--Warnings-----
Aristospan (triamcinolone hexacetonide) Injection Suspension--Warnings-----
Brintellix (vortioxetine) Tablets --WarningsPrecautionsAdverse Reactions---
Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate) Injection Suspension--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Celexa (citalopram hydrobromide) Tablets--WarningsPrecautionsAdverse Reactions---
Cymbalta (duloxetine hydrochloride) Capsules--WarningsPrecautionsAdverse Reactions---
DEPO-MEDROL  (methylprednisolone acetate injectable suspension, USP)--Warnings-----
Desvenlafaxine Fumarate Extended-Release Tablets --WarningsPrecautionsAdverse Reactions---
Desyrel (trazodone hydrochloride) Tablets--WarningsPrecautionsAdverse Reactions---
Docetaxel Injection--WarningsPrecautionsAdverse Reactions---
Effexor XR (venlafaxine hydrochloride) extended-release tablets --WarningsPrecautionsAdverse Reactions---
Fetzima (levomilnacipran) extended-release capsules--WarningsPrecautionsAdverse Reactions---
Fortical (calcitonin-salmon [rDNA origin]) Nasal Spray for Intranasal Use--WarningsPrecautionsAdverse Reactions---
Flomax (tamsulosin hydrochloride) Capsules--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Fluoxetine Tablets--WarningsPrecautionsAdverse Reactions---
Forfivo XL (bupropion hydrochloride Extended-Release Tablets --WarningsPrecautionsAdverse Reactions---
Hexadrol (dexamethasone sodium phosphate) Injection--Warnings-----
Humatrope (somatropin [rDNA origin] for injection)--WarningsPrecautions----
Jakafi (ruxolitinib phosphate) Tablets--WarningsPrecautions----
Kadcyla (ado-trastuzumab emtansine) for injection, for intravenous Use--WarningsPrecautionsAdverse Reactions---
Kenalog Injection (triamcinolone acetonide injectable suspension)--Warnings-----
Khedezla (desvenlafaxine base extended-release) Tablets--WarningsPrecautionsAdverse Reactions---
Lexapro (escitalopram oxalate) Tablets and Oral Solution--WarningsPrecautionsAdverse Reactions---
Luvox (fluvoxamine maleate) Tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Luvox CR (fluvoxamine maleate) Extended-Release Capsules--WarningsPrecautionsAdverse Reactions---
Norpramin (desipramine hydrochloride tablets USP)--WarningsPrecautionsAdverse Reactions---
Oleptro (trazodone hydrochloride) extended-release tablets--WarningsPrecautionsAdverse Reactions---
Pamelor (nortriptyline HCl) Solution (Pamelor (nortriptyline HCl) Capsules--WarningsPrecautionsAdverse Reactions---
Paxil (paroxetine hydrochloride) tablets, oral suspension and controlled-release tablets--WarningsPrecautionsAdverse Reactions---
Pexeva (paroxetine mesylate) Tablets--WarningsPrecautionsAdverse Reactions---
Pristiq (desvenlafaxine) Extended-Release Tablets--WarningsPrecautionsAdverse Reactions---
Prozac (fluoxetine hydrochloride) Delayed Release Capsules--WarningsPrecautionsAdverse Reactions---
Prozac (fluoxetine hydrochloride) Pulvules--WarningsPrecautionsAdverse Reactions---
Remeron (mirtazapine) Tablets Remeron SolTab orally disintegrating tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Sinequan (doxepin hydrochloride) Capsules and Oral Concentrate--WarningsPrecautionsAdverse Reactions---
Solu-Cortef (hydrocortisone sodium succinate) Injection and Sterile Powder for Injection--Warnings-----
Solu-Medrol (methylprednisolone sodium succinate) Sterile Powder for Injection--Warnings-----
Surmontil (Trimipramine Maleate) Capsules --WarningsPrecautionsAdverse Reactions---
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules--WarningsPrecautionsAdverse Reactions---
Tofranil-PM (imipramine pamoate) Capsules--WarningsPrecautionsAdverse Reactions---
Trelstar (triptorelin pamoate for injectable suspension) Intramuscular use--WarningsPrecautions----
Trileptal (oxcarbazepine) film-coated tablets and oral suspension for oral administration --WarningsPrecautions----
Vantas (histrelin acetate) subcutaneous implant--WarningsPrecautions----
Venlafaxine Hydrochloride Extended-Release Capsules--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Victrelis (boceprevir) Capsules--WarningsPrecautions----
Viibryd (vilazodone hydrochloride) Tablets --WarningsPrecautionsAdverse Reactions---
Vivactil (protriptyline HCL) Tablets --WarningsPrecautionsAdverse Reactions---
Wellbutrin (bupropion hydrochloride) Wellbutrin SR and Wellbutrin XL Sustained-Release Tablets--WarningsPrecautionsAdverse Reactions---
Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets--WarningsPrecautions----
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate --WarningsPrecautionsAdverse Reactions---
Azor (amlodipine and olmesartan medoxomil) tablets, for oral use---Precautions----
Edarbi (azilsartan medoxomil) Tablets---Precautions----
Edarbyclor (azilsartan medoxomil/chlorthalidone) Tablets---Precautions----
Effexor XR (venlafaxine hydrochloride) extended-release tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Excedrin Migraine (acetaminophen and caffeine) Tablets, Caplets and Geltabs---Precautions----
Lupron (leuprolide acetate) Injection---Precautions----
Namenda XR (Memantine Hydrochloride Extended-Release) Capsules---Precautions----
Teveten (eprosartan mesylate)---Precautions----
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets---Precautions----
Adderall XR (dextroamphetamine mixed salts of a single entity amphetamine product) Capsules----Adverse Reactions---
Biaxin Filmtabs (clarithromycin tablets, USP) Biaxin Granules (clarithromycin for oral suspension USP) Biaxin XL Filmtabs (clarithromycin extended release tablets)----Adverse Reactions---
Cardene (nicardipine hydrochloride) Injection----Adverse Reactions---
Crestor (rosuvastatin calcium) tablets----Adverse Reactions---
Crixivan (indinavir sulfate)----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Implanon (etonogestrel implant), For Subdermal Use----Adverse Reactions---
Nexplanon (etonogestrel implant), Radiopaque, Subdermal Use Only----Adverse Reactions---
Vyvanse (lisdexamfetamine dimesylate) Capsules----Adverse Reactions---
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