FDA MedWatch - November 2009 Drug Safety Labeling Changes: 44 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - November 2009 Drug Safety Labeling Changes: 44 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 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/ucm191946.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:

• Actiq (fentanyl citrate)
• Adenocard (adenosine)
• Adenoscan (adenosine)
• Avandaryl (rosiglitazone maleate and glimepiride)
• Byetta (exenatide)
• Cimzia (certolizumab pegol)
• Cleocin HCL (clindamycin hydrochloride)
• Enbrel (etanercept)
• Humira (adalimumab)
• Lotensin (benazepril hydrochloride)
• Lotensin HCT (benazepril/hydrochlorothiazide)
• Lopressor (metoprolol tartrate)
• Norvir (ritonavir) capsule and solution
• Parnate (tranylcypromine sulfate)
• Plavix (clopidogrel bisulfate)
• Qualaquin (quinine sulfate)
• Rebetol (ribavirin), Soma (carisoprodol)
• Remicade (infliximab)
• Simponi (golimumab)
• Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
• Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
• Tekturna (aliskiren)

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