In July 2016, 52 drug products have had changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
See below for a list of drugs that had modifications to the specified 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)
For more information about the specific safety labeling changes, go to the FDA’s website. For general information about drug labeling changes and monthly summaries, click here.
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