Drug Safety Labeling Changes February 2010

 Drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections during February 2010.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME	SECTIONS MODIFIED
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Caduet (amlodipine besylate/atorvastatin calcium) tablets1		X	X	X	X
Cialis (tadalafil) tablets2		X	X	X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Accutane (isotretinoin) capsules3			X
Bystolic (nebivolol) tablets4			X	X
Carbocaine (mepivacaine HCl) injection5 *risk of chondrolysis			X
Didrex (benzphetamine hydrochloride) tablets6			X	X	X
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine) tablets7			X
Genotropin (somatropin [rDNA origin] for injection8			X	X
Lanoxin (digoxin) pediatric injection and tablets9			X
Marcaine (bupivacaine HCl) injection10 Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine) injection11 Marcaine Spinal (bupivacaine HCl) dextrose injection12 *risk of chondrolysis			X
Naropin (ropivacaine HCl) injection13 *risk of chondrolysis			X
Nesacaine (chloroprocaine HCl) injection14 Nesacaine-MPF (chloroprocaine HCl) injection15 *risk of chondrolysis			X
Norvasc (amlodipine besylate) tablets16			X	X	X
Prepidil (dinoprostone) cervical gel17			X
Rocephin (ceftriaxone sodium) IV and IM18			X
Savella (milnacipran HCl) tablets19			X
Treanda (bendamustine hydrochloride) for injection, for intravenous infusion20			X	X
Xylocaine (lidocaine HCl) injection21 Xylocaine (lidocaine HCl and epinephrine) injection22 Xylocaine (lidocaine HCl) 4% solution23 *risk of chondrolysis			X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Cefoxitin for injection and Dextrose injection in the Duplex container24				X
Intelence (etravirine) 100 mg tablets25				X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Dyazide (hydrochlorothiazide/triamterene) capsules26					X
Forane (isoflurane) liquid for inhalation27					X
Niaspan (niacin) extended release tablets28					X
Pristiq (desvenlafaxine) extended-release tablets29					X