FDA MedWatch - February 2010 Drug Safety Labeling Changes: 24 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - February 2010 Drug Safety Labeling Changes: 24 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

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)

 

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