The MedWatch February 2010 Drug Safety Labeling Changes

The MedWatch February 2010 Drug Safety Labeling Changes posting includes 24 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm202912.htm

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 to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Caduet (amlodipine besylate/atorvastatin calcium)
Cialis (tadalafil)
Accutane (isotretinoin)
Bystolic (nebivolol)
Carbocaine (mepivacaine HCl)
Didrex (benzphetamine hydrochloride)
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine)
Genotropin (somatropin [rDNA origin]
Lanoxin (digoxin)
Marcaine (bupivacaine HCl)
Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine)
Marcaine Spinal (bupivacaine HCl)
Naropin (ropivacaine HCl)
Nesacaine (chloroprocaine HCl)
Nesacaine-MPF (chloroprocaine HCl)
Norvasc (amlodipine besylate)
Prepidil (dinoprostone)
Rocephin (ceftriaxone sodium)
Savella (milnacipran HCl)
Treanda (bendamustine hydrochloride)
Xylocaine (lidocaine HCl)
Xylocaine (lidocaine HCl and epinephrine)