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The November 2008 posting includes 29 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, 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/nov08_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/nov08.htm
In November 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Premarin (conjugated estrogens) Vaginal Cream
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Viread (tenofovir disoproxil fumarate) Tablets
Promethazine HCl and Codeine Phosphate Oral Solution
Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution
Ranexa (ranolazine) Extended-Release Tablets
Sucraid (sacrosidase) Oral Solution
Aldactone (spironolactone tablets, USP)
Avastin (bevacizumab) For Intravenous Use
Boniva (ibandronate sodium) Tablets
Ethyol (amifostine) For Injection
Selzentry (maraviroc) Tablets
Triglide (fenofibrate) Tablets
You are encouraged to report all serious adverse events and product quality problems for human medical products to MedWatch at: www.fda.gov/medwatch/report.htm.
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