The U.S. Food and Drug Administration has published safety labeling changes made prescribing information for 34 products in September.
Changes were made to boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert and medication guide.
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
To view a listing of drug names and safety labeling sections revised, click here. 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.
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