January 2012
Safety Labeling Changes
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.
Key to Label Section Acronyms:
BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE
BW
C
W
P
AR
PPI/MGAccupril (quinapril hydrochloride) 5 mg, 10 mg 20 mg, 40 mg Tablets
* Anti-Hypertensive Drugs
Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets
* Anti-Hypertensive Drugs
X X X XAltace (ramipril) 1.25, 2.5, 5, and 10 mg Tablets
* Anti-Hypertensive Drugs
X XX XAvalide (irbesartan/hydrochlorothiazide) Tablets, 150/12.5 mg and 300/12.5 mg
* Anti-Hypertensive Drugs
X XX XAvapro (irbesartan) 75 mg, 150 mg, and 300 mg Tablets
* Anti-Hypertensive Drugs
X XX XAzor (amlodipine/olmesartan) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
* Anti-Hypertensive Drugs
X XX XBenicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets
* Anti-Hypertensive Drugs
X XX XDiovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets
* Anti-Hypertensive Drugs
X XX X
* Anti-Hypertensive Drugs
X XX XExforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
* Anti-Hypertensive Drugs
X XX X
* Anti-Hypertensive Drugs
X XX XLotensin (benazepril) 5 mg, 10 mg, 20 mg, and 40 mg Tablets
* Anti-Hypertensive Drugs
X XX X
* Anti-Hypertensive Drugs
X XX X
* Anti-Hypertensive Drugs
X XX XMavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets
* Anti-Hypertensive Drugs
X XX XMicardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets
* Anti-Hypertensive Drugs
X XX XMicardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets
* Anti-Hypertensive Drugs
X XX XTarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg 2/240 mg and 4/240 mg Tablets
* Anti-Hypertensive Drugs
X XX XTeveten (eprosartan mesylate) 400 mg and 600 mg Tablets
* Anti-Hypertensive Drugs
X XX XTeveten HCT (eprosartan mesylate/hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets
* Anti-Hypertensive Drugs
X XX X
* Anti-Hypertensive Drugs
X XX XUnivasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets
Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets
* Anti-Hypertensive Drugs
BW
C
W
P
AR
PPI/MGCeftriaxone for Injection and Dextrose Injection in Duplex Container XX X Evoclin (clindamycin phosphate) Foam X X X X PPI Mavik (trandolapril) 1 mg, 2 mg, and 4 mg Tablets XXX X Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets X X Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, and 80/12.5 mg, and 80/25 mg Tablets XX X Micardis HCT (telmisartan/hydrochlorothiazide) Tablets XX X Twynsta (telmisartan/amlodipine) Tablets X XPPIXenical (orlistat) Capsules XX X (Click on drug name to go to detailed view)BW
C
W
P
AR
PPI/MGChantix (varenicline) Tablets 0.5 mg and 1 mg XXX Erbitux (cetuximab) XX Fanapt (iloperidone) Tablets XX Fazaclo (clozapine) Orally Disintegrating Tablets XXX Gralise (gabapentin) Tablets, 300 mg and 600 mg XX Morphine Sulfate Oral Solution, 10 mg/5 mL, 20 mg/5 mL, and 100 mg/5 mL XXXMGMorphine Sulfate Tablets, 15 mg and 30 mg XXXPCINexium (esomeprazole sodium) For Injection XXX Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg;Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg XXXMGPerforomist (formoterol fumarate) Inhalation Solution XXX Pradaxa (dabigatran etexilate mesylate) Capsules XX MG Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets XXXMGVytorin (ezetimibe/simvastatin) Tablets XXX (Click on drug name to go to detailed view)
BW
C
W
P
AR
PPI/MG
*Renin Inhibitors
XX Droxia (hydroxyurea capsules, USP) 200 mg, 300 mg, 400 mg and Hydrea (hydroxyurea capsules, USP) 500 mg X Marcaine and Marcaine with Epinephrine InjectionMarcaine Spinal Injection
Bupivacaine hydrochloride and epinephrine bitartrate injection X Multaq (dronedarone hydrochloride) 400 mg Tablets X Parlodel SnapTabs (bromocriptine mesylate) Tablets and Capsules X
Tekamlo (aliskiren/amlodipine) 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg and 300 mg/10 mg Tablets
*Renin Inhibitors
XXTekturna (aliskiren) 150 mg, 300 mg Tablets
*Renin Inhibitors
*Renin Inhibitors
XXValturna (aliskiren and valsartan) 150/160 mg and 300/320 mg Tablets
*Renin Inhibitors
XX Zetia (ezetimibe) Tablets X Zyban (bupropion hydrochloride) Sustained-Release Tablets X (Click on drug name to go to detailed view)BW
C
W
P
AR
PPI/MGAstelin (azelastine) Nasal SprayLupron Depot (leuprolide acetate for depot suspension), 11.25 mg
Lupron Depot (leuprolide acetate for depot suspension), 3.75 mg
X Synarel (nafarelin acetate) nasal solution, 2 mg/mL X VESIcare (solifenacin succinate) Tablets X Vidaza (azacitidine) for Injection X Welchol (colesevelam HCL) Tablets and Welchol (colesevelam HCl) for Oral Suspension X Zonegran (zonisamide) Capsules