viernes, 19 de febrero de 2010

FDA MedWatch - January 2010 Drug Safety Labeling Changes: 36 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Re

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:

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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