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The MedWatch December 2010 Safety Labeling Changes posting includes 58 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm235838.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
Ablavar (gadofosveset trisodium)
Aceon (perindopril erbumine)
Baraclude (entecavir)
Copegus (ribavirin)
Eovist (Gadoxetate disodium) injection
Innopran XL (propranolol hydrochloride)
Magnevist (gadopentetate dimeglumine)
MultiHance (gadobenate dimeglumine)
Omniscan (gadodiamide)
Optimark (gadoversetamide)
Prilosec OTC (omeprazole magnesium)
Pristiq (desvenlafaxine)
Prohance (gadoteridol)
Relenza (zanamivir)
Remicade (inflximab)
Terconazole Vaginal Cream
Zegerid OTC capsules
Zerit (stavudine)
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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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