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September 2010 Safety Labeling Changes: 37 Medical Product Labels with changes to Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch September 2010 Safety Labeling Changes posting includes 37 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/ucm228392.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:
Aciphex (rabeprazole sodium)
Alli (orlistat)
Altabax (retapamulin)
Apokyn (apomorphine hydrochloride)
Arava (leflunomide)
Casodex (bicalutamide)
Combunox (Oxycodone HCl/ibuprofen)
Desferal (deferoxamine mesylate)
Dexilant (dexlansoprazole)
Faslodex (fulvestrant)
Minocin (minocycline hydrochloride)
Nexium (esomeprazole magnesium)
Nexium I.V. (esomeprazole sodium)
Noxafil (posaconazole)
Prevacid (lansoprazole)
Prilosec (omeprazole magnesium)
Protonix (pantoprazole sodium)
Rotarix (rotavirus vaccine, live, oral)
Zegerid (omeprazole/sodium bicarbonate)
Zegerid with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide)
Zofran (ondansetron hydrochloride)
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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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