September 2010 FDA Safety Labeling Changes
In the second half of each month, the FDA publishes a list of all safety labeling changes for the previous month. The MedWatch September 2010 safety labeling changes posting includes 37 products with 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 revised safety labeling sections. Selecting a drug product name in the summary view will take you to the detailed view page, which identifies revised safety labeling sections and subsections, 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 IV (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)
