MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on web

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This is a keeper - for future reference . . .You may recognize a lot of these meds! . .. Rogenecarwol@... wrote: News from the FDA.. some of these drugs are highly advertised....Carolyn=============Date: Thu, 24 Apr 2008 16:09:55 -0500 (CDT)From: "U.S. Food & Drug Administration (FDA)" Subject: MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on webMedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES. The Summary Page provides a

listing of drug names and safety labeling sections revised: _http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm_ [ http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm ] The Detailed View Page 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: _http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm_ [ http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm ] In January 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: EstroGel 0.06% (estradiol gel) Herceptin (trastuzumab) Intravenous Infusion Rituxan (rituximab) Injection For Intravenous Use Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets) Janumet (sitagliptin/metformin HCl) Tablets Mycamine (micafungin sodium) For Injection

Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use Tysabri (natalizumab) Injection For Intravenous Use WelChol (colesevelam hydrochloride) Tablets Azactam (aztreonam for injection, USP) Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use Chantix (varenicline) Tablets Cialis (tadalafil) Tablets E.E.S. (erythromycin ethylsuccinate) Ery-Ped (erythromycin ethylsuccinate, USP) Humira (adalimumab) Injection, Solution For Subcutaneous Use Lunesta (eszopiclone) Tablets Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) PCE (erythromycin particles in tablets) Dispertab Tablets Rapamune (sirolimus) Oral Solution and Tablets ________________________________________________________________________This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [

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