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The MedWatch July 2014 Safety Labeling Changes posting includes 73 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 product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm409189.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Afinitor (everolimus)
Afinitor Disperz (everolimus tablets for oral suspension)
Anafranil (clomipramine)
Aptryxol (desvenlafaxine)
Aristocort Forte (Triamcinolone Diacetate, USP)
Aristospan (triamcinolone hexacetonide)
Arixtra (fondaparinux sodium)
Brintellix (vortioxetine)
Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine hydrochloride)
DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)
Desvenlafaxine Fumarate
Desyrel (trazodone hydrochloride)
Docetaxel Injection
Effexor XR (venlafaxine hydrochloride)
Fetzima (levomilnacipran)
Flomax (tamsulosin hydrochloride)
Fluoxetine Tablets
Forfivo XL (bupropion hydrochloride)
Fortical (calcitonin-salmon [rDNA origin])
Hexadrol (dexamethasone sodium phosphate)
Humatrope (somatropin [rDNA origin] for injection)
Jakafi (ruxolitinib phosphate)
Kadcyla (ado-trastuzumab emtansine)
Kenalog Injection (triamcinolone acetonide injectable suspension)
Khedezla (desvenlafaxine base extended-release)
Lexapro (escitalopram oxalate)
Linzess (linaclotide)
Luvox (fluvoxamine maleate)
Luvox CR (fluvoxamine maleate)
Norpramin (desipramine hydrochloride tablets USP)
Oleptro (trazodone hydrochloride)
Pamelor (nortriptyline HCl)
Paxil (paroxetine hydrochloride)
Pexeva (paroxetine mesylate)
Pristiq (desvenlafaxine)
Prozac (fluoxetine hydrochloride)
Prozac (fluoxetine hydrochloride) Pulvules
Remeron (mirtazapine)
Sinequan (doxepin hydrochloride)
Solu-Cortef (hydrocortisone sodium succinate)
Solu-Medrol (methylprednisolone sodium succinate)
Surmontil (Trimipramine Maleate)
Symbyax (olanzapine and fluoxetine hydrochloride)
Tofranil-PM (imipramine pamoate)
Trelstar (triptorelin pamoate for injectable suspension)
Trileptal (oxcarbazepine)
Vantas (histrelin acetate)
Venlafaxine Hydrochloride
Victrelis (boceprevir)
Viibryd (vilazodone hydrochloride)
Vivactil (protriptyline HCL)
Wellbutrin (bupropion hydrochloride)
Zelapar (selegiline hydrochloride)
Zoloft (sertraline hydrochloride)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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