Home > FDA MedWatch > FDA MedWatch – September 2011 Safety Labeling Changes

FDA MedWatch – September 2011 Safety Labeling Changes

The MedWatch September 2011 Safety Labeling Changes posting includes 34 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/ucm274280.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:

Detrol (tolterodine tartrate) tablets and Detrol LA (tolterodine tartrate) extended release tablets
Orap (pimozide) 1 mg and 2 mg tablets
Anzemet (dolasetron mesylate) tablets and Anzemet (dolasetron mesylate) injection
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
Avastin (bevacizumab)
Cymbalta (duloxetine hydrochloride)
Effient (prasugrel hydrochloride) 5 mg and 10 mg Tablets
Ellence (epirubicin hydrochloride) injection
Istodax (romidepsin) for Injection
Lexiscan (regadenoson) Injection
MultiHance (gadobenate dimeglumine) injection
Nicorette (nicotine polacrilex) 2 mg and 4mg gum [OTC]
Procardia (nifedipine) 10 mg Capsules
Procardia XL (nifedipine) 30 mg, 60 mg, and 90 mg Extended Release Capsules
Stimate (desmopressin acetate) 1.5 mg/mL nasal spray
Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension for intramuscular use
Risperdal (risperidone) tablets, oral solution
Risperdal M-Tab (risperidone) orally disintegrating tablets
Risperdal Consta (risperidone) long-acting injection
Xenon Xe 133 Gas, 10 and 20 mCi, septum sealed glass vial
Zofran (ondansetron hydrochloride) injection and premixed injection
Zofran (ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets

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