September 2011 Medication Label Changes

Last month brought changes to thirty-four (34) medical product labels (down from 45 changes in August), with changes to the prescribing information to include any of the following areas: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.


New Medication Label Changes

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following drugs have been effected:

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