[brian]

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/2..._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