FDA MedWatch - July 2016 Safety Labeling Changes includes 52 products with revisions to Prescribing Information

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - July 2016 Safety Labeling Changes includes 52 products with revisions to Prescribing Information

 

The MedWatch July 2016 Safety Labeling Changes posting includes 52 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

The "Summary Page" table provides a listing of product names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm514705.htm

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and/or PRECAUTIONS sections:

Avelox (moxifloxacin hydrochloride)
Acetadote (acetylcysteine) Injection
Alinia (nitazoxanide)
Aromasin (exemestane)
Asmanex HFA (mometasone furoate)
Caprelsa (vandetanib)
Cipro (ciprofloxacin hydrochloride) Tablets, Solution, Oral Suspension
Cipro XR (ciprofloxacin extended release) Tablets 
Clinolipid (lipid injectable emulsion)
Dexilant (dexlansoprazole delayed-release capsules) 
Dulera (formoterol fumarate, mometasone furoate)
Dysport (abobotulinumtoxinA)
Effient (prasugrel)
Eliquis (apixaban)
Epivir (lamivudine) Tablets and Oral Solution
Evotaz (atazanavir/cobicistat)
Factive (gemifloxacin mesylate) 
Faslodex (fulvestrant)
Flovent Diskus (fluticasone propionate inhalation powder)
Flovent HFA (fluticasone propionate)
Glyxambi (empagliflozin and linagliptin)
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)
Humulin R U-500 (insulin human injection)
Ilaris (canakinumab)
Isoniazid Tablets
Jardiance (empagliflozin)
Kadcyla (ado-trastuzumab emtansine)
Kepivance (palifermin) Injection
Lamprene (clofazimine)
Levaquin (levofloxacin)
Mirapex (pramipexole)
Mirapex ER (pramipexole) extended-release
Mirvaso (brimonidine)
Moxifloxacin Injection
Namzaric (memantine and donepezil hydrochlorides) Extended-release
Noroxin (norfloxacin)
Plegridy (peginterferon beta-1a)
Pravachol (pravastatin sodium)
Prismasol and Phoxillum Renal Replacement Solution
Synjardy (empagliflozin and metformin hydrochloride)
Tarka (trandolapril/verapamil hydrochloride ER tablets)
Thallous Chloride T1201 Injection
Xolair (omalizumab) Lyophilized Powder
Yondelis (trabectedin)

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