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The MedWatch January 2010 Drug Safety Labeling Changes posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm200254.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
- Exjade (deferasirox)
- Aristocort Forte (triamcinolone diacetate)
- Boniva (ibandronate sodium)
- Effexor (venlafaxine HCl)
- Invirase (saquinavir mesylate)
- Kaletra (lopinavir/ritonavir)
- RotaTeq (rotavirus vaccine, live, pentavalent)
- Tykerb (lapatinib)
- Cancidas (caspofungin acetate)
- Cardene (nicardipine hydrochloride)
- Coumadin (warfarin sodium)
- Crestor (rosuvastatin calcium)
- Kenalog (triamcinolone acetonide)
- Pexeva (paroxetine mesylate)
- R-Gene 10 (arginine hydrochloride)
- Remodulin (treprostinil)
- Symbyax (olanzapine and fluoxetine hydrochloride)
- Toprol-XL (metoprolol succinate)
- Videx EC (didanosine)
- Viramune (nevirapine)
- Zyprexa (olanzapine)
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