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)
