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The MedWatch September 2014 Safety Labeling Changes posting includes 55 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/ucm417235.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Aloxi (palonosetron hydrochloride) Injection
Aloxi (palonosetron hydrochloride) Oral Capsules
Anzemet (dolasetron mesylate) injection, 20 mg/mL
Anzemet (dolasetron mesylate) tablets, 50 mg and 100 mg
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets
Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
Benicar (olmesartan medoxomil) 5 mg, 20 mg, and 40 mg Tablets
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, and 40.12.5 mg, and 40/25 mg Tablets
Chantix (varenicline) Tablets; 0.5 mg and 1 mg
Clolar (clofarabine) Injection, 1 mg/mL
Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets
Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets
Diovan (valsartan) 80 mg and 160 mg Capsules
Docetaxel Injection Concentrate, 20 mg/1 mL, 80 mg/4 mL, and 140 mg/7 mL
Emsam (Selegiline Transdermal System) 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets
Fosrenol (lanthanum carbonate) chewable tablets 500 mg, 750 mg and 1000 mg
Genotropin (somatropin [rDNA origin] for injection)
Halcion (triazolam) tablets, 0.25 mg
Hyzaar (losartan potassium/hydrochlorothiazide) 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets
Latisse (bimatoprost ophthalmic solution), 0.03 percent
Lexiscan (regadenoson) Injection
Lumigan (bimatoprost ophthalmic solution), 0.01 percent
Lumigan (bimatoprost ophthalmic solution), 0.03 percent
Lumizyme (aglucosidase alfa)
MembraneBlue (trypan blue ophthalmic solution) 0.15 percent
Minivelle (estradiol transdermal system) 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day
Namenda XR (memantine hydrochloride extended-release) Capsule, 7 mg, 14 mg, 21 mg, and 28 mg
Norditropin Cartridges (somatropin [rDNA origin] injection)
Nulojix (belatacept)
Olysio (simeprevir), 150 mg capsules
Ozurdex (dexamethasone intravitreal implant) 0.7 mg
Pegasys (peginterferon alfa-2a)
Qsymia (phentermine and topiramate extended-release) capsules
Revlimid (lenalidomide) Capsules 2.5, 5, 10, 15, 20, and 25 mg
Sancuso (granisetron)
Tasigna (nilotinib) capsules, 150 and 200 mg
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, Tegretol-XR (carbamazepine extended-release)
Tribenzor (olmesartan /medoxomil / amlodipine / hydrochlorothiazide) 20/5/12.5 mg, 40/5/25 mg, 40/10/12.5 mg, and 40/10/25 mg Tablets
Velphoro (sucroferric oxyhydroxide) Chewable Tablets, 500 mg Iron
Vibramycin (doxycycline hyclate) Capsules
Vibramycin (doxycycline hyclate) Intravenous
Vibramycin Calcium (doxycycline calcium oral suspension) Syrup
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension
Vibra-Tabs (doxycycline hyclate) Film Coated Tablets
Xolair (omalizumab)
Xylocaine Viscous (lidocaine HCl) Solution, 2 percent
Zofran (ondansetron hydrochloride) Injection
Zofran (ondansetron hydrochloride) Oral Solution
Zofran (ondansetron hydrochloride) Tablets
Zofran ODT (ondansetron) Orally Disintegrating Tablets
Zoloft (sertraline hydrochloride) 20mg/mL Oral Concentrate
Zuplenz (ondansetron) oral soluble film
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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