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The MedWatch August 2009 Drug Safety Labeling Changes posting includes 35 drug products with safety labeling changes to the following sections: BOXED WARNING, 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/ucm181141.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 to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
DexFerrum (iron dextran), INFeD (iron dextran), Tasigna (nilotinib), Arixtra (fondaparinux sodium), Flagyl (metronidazole), Inomax (nitric oxide), Lariam (mefloquine hydrochloride), Letairis (ambrisentan), Lopressor HCT (metoprolol tartrate and hydrochlorothiazide), Merrem (meropenem), Primaxin (imipenem and cilastatin), Pristiq (desvenlafaxine), Tobramycin, Zoladex (goserelin acetate).
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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