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

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

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

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