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
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