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.
Related Articles on Medication Safety:
8 Steps to Prevent Medication Errors in Surgery Centers
Nurse at Alta Bates Summit Medical Center Administered Fatal Medication Dose
Staff Education Tool: Medication Safety Reconciliation Toolkit
