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The MedWatch December 2012 Safety Labeling Changes posting includes 42 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm332340.htm The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS and/or WARNINGS sections:
- Altabax (Retapamulin)
- Antara (Fenofibric Acid)
- Celexa (Citalopram Hydrobromide)
- Chantix (Varenicline)
- Edurant (Rilpivirine)
- Effexor (Venlafaxine Hydrochloride)
- Effexor XR (Venlafaxine Hydrochloride)
- Fibricor (Fenofibric Acid)
- Horizant (Gabapentin Enacarbil)
- Incivek (Telaprevir)
- Lexapro ( Escitalopram Oxalate)
- Omeprazole Sodium Bicarbonate and Magnesium Hydroxide
- Omontys (Peginesatide)
- Paxil (Paroxetine Hydrochloride)
- Pexeva (Paroxetine Mesylate)
- Pradaxa (Dabigatran Etexilate)
- Pristiq (Desvenlafaxine)
- Sabril (Vigabatrin)
- Surmontil (Trimipramine Maleate)
- Tamiflu (Oseltamivir Phosphate)
- Venlafaxine
- Viibryd (Vilazodone HCL)
- Xyrem (Sodium Oxybate)
- Zoloft (Sertraline Hydrochloride)
- Zytiga (Abiraterone Acetate)
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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