sábado, 14 de mayo de 2016

Safety Information > April 2016

Safety Information > April 2016

FDA MedWatch - April 2016 Drug Safety Labeling Changes includes 29 products with revisions to Prescribing Information

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch April 2016 Safety Labeling Changes posting includes 29 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, orPRECAUTIONS sections:

Aciphex (rabeprazole sodium) Delayed-release Tablets, for Oral Use and Aciphex Sprinkle (rabeprazole sodium delayed-release capsules) 
Betaseron (interferon beta-1b) for Injection, for Subcutaneous Use 
Cialis (tadalafil) Tablets, For Oral Use 
Cimzia (certolizumab pegol) for Injection, for Subcutaneous Use  
Cordarone (amiodarone HCl) Tablets 
Gilotrif (afatinib) Tablets, for Oral Use 
Kadcyla (ado-trastuzumab emtansine) for Injection, for Intravenous Use  
Lenvima (lenvatinib) Capsules, for Oral Use 
Limbitrol (chlordiazepoxide and amitriptyline HCI) and Limbitrol DS  
Lopid (gemfibrozil Tablets, USP)
Nesina (alogliptin) Tablets, for Oral Use
Nplate (romiplostim) for Injection, for Subcutaneous Use
Onglyza (saxagliptin) Tablets, for Oral Use
Oxaliplatin Injection for Intravenous Use 
Precedex (dexmedetomidine hydrochloride) Injection and Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection
Ringer’s Injection, USP in VIAFLEX Plastic Container 
Skyla (levonorgestrel-releasing intrauterine system)
Tivicay (dolutegravir) Tablets, For Oral Use 
Triumeq (abacavir, dolutegravir, and lamivudine) Tablets, For Oral Use
Vibramycin (doxycycline hyclate) Intravenous
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension, Vibramycin Hyclate (doxycycline hyclate capsules, USP), Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate tablets, USP)
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use 
Zestril (lisinopril) Tablets, for Oral Use 
Zonegran (zonisamide) Capsules, for Oral Administration  

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