sábado, 13 de febrero de 2016

FDA MedWatch - January 2016 Drug Safety Labeling Changes includes 26 products with revisions to Prescribing Information.

Safety Information > January 2016

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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:
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)  

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