Drug Safety Labeling Changes - September 2011

Get news by email or subscribe to our news feeds.

September 2011

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Detrol (tolterodine tartrate) tablets and Detrol LA (tolterodine tartrate) extended release tablets-ContraindicationsWarnings-Adverse ReactionsPatient Package Insert--
Orap (pimozide) 1 mg and 2 mg tablets-Contraindications-Precautions----
Anzemet (dolasetron mesylate) tablets and Anzemet (dolasetron mesylate) injection--Warnings-----
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets--WarningsPrecautionsAdverse Reactions---
Effient (prasugrel hydrochloride) 5 mg and 10 mg Tablets--WarningsPrecautions----
Ellence (epirubicin hydrochloride) injection--Warnings-----
Istodax (romidepsin) for Injection--WarningsPrecautions----
MultiHance (gadobenate dimeglumine) injection--WarningsPrecautions----
Nicorette (nicotine polacrilex) 2 mg and 4mg gum [OTC]--Warnings-----
Procardia (nifedipine) 10 mg Capsules--Warnings-Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Procardia XL (nifedipine) 30 mg, 60 mg, and 90 mg Extended Release Capsules--Warnings-Adverse Reactions---
Risperdal (risperidone) tablets, oral solutionRisperdal M-Tab (risperidone) orally disintegrating tabletsRisperdal Consta (risperidone) long-acting injection--WarningsPrecautions----
Stimate (desmopressin acetate) 1.5 mg/mL nasal spray--Warnings-----
Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension for intramuscular use--WarningsPrecautions----
Xenon Xe 133 Gas, 10 and 20 mCi, septum sealed glass vial--Warnings-----
Zofran (ondansetron hydrochloride) injection and premixed injection--Warnings-----
Zofran (ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets--Warnings-----
Claforan (cefotaxime sodium) Injection---Precautions----
Sanctura (trospium chloride) and Sanctura XR (trospium chloride extended release)---Precautions----
Tarka (trandolapril/verapamil hydrochloride) tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Aldactazide (spironolactone/hydrochlorothiazide) tablets----Adverse Reactions---
Fosrenol (lanthanum carbonate) 500 mg, 750 mg, and 1000 mg Chewable Tablets----Adverse Reactions---
Latisse (bimatoprost) ophthalmic solution----Adverse Reactions---
Lexiscan (regadenoson) injection----Adverse Reactions---
Travatan (travoprost) and Travatan Z (travoprost)----Adverse Reactions---
Vyvanse (lisdexamfetamine dimesylate)----Adverse Reactions---
Doxorubicin (doxorubicin hydrochloride) for injection-----Patient Package Insert--
Hide
(web4)