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The MedWatch January 2016 Safety Labeling Changes posting includes 26 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/ucm485289.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections:
Botox (onabotulinumtoxinA)
Epaned (enalapril maleate) 1 mg/mL Powder (reconstituted) for Oral Solution
Fanapt (iloperidone) Tablets
Gleostine (Lomustine) Capsules
Halaven (eribulin mesylate) Injection
Hylenex recombinant (hyaluronidase human injection)
Kyprolis (carfilzomib) for Injection
Lotronex (alosetron hydrochloride) Tablets
Mavik (trandolapril) Tablets
Miostat (carbachol intraocular solution, USP)
Orbactiv (oritavancin diphosphate) Lyophilized Powder for Injection
Propylthiouracil Tablets
Simponi (golimumab) Injection
Simponi Aria (golimumab) Injection, for Intravenous Infusion
Tarka (trandolapril/verapamil) Tablets
Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets
Topotecan Injection
Trental (pentoxifylline) Tablets
Twynsta (telmisartan/amlodipine) Tablets
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets)
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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