April 2012 Safety Labeling Changes

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The MedWatch April 2012 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. 

 

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm

 

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

 

Aceon (Perindopril Erbumine)

Altace (Ramipril)

Atacand (Candesartan Cilexetil)

Sporanox (Itraconazole)

Zortress (Everolimus)

Advicor (Niacin Extended-release/Lovastatin)

Altoprev (Lovastatin Extended-release)

Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide)

Premarin (Conjugated Estrogens,USP)

Tekamlo (Aliskiren and Amlodipine)

Tekturna (Aliskiren)

Tekturna HCT (Aliskiren and Hydrochlorothiazide)

Vagifem (Estradiol)

Valturna (Aliskiren and Valsartan)

Viracept (nelfinavir mesylate)

 

Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)

Cimzia (Certolizumab Pegol) 

Krystexxa (Pegloticase)

Levaquin (Levofloxacin) 

Levemir (Insulin Detemir [rDNA origin])

Neupro (Rotigotine)

Nutropin (Somatropin [rDNA origin])

Prandimet (Repaglinide and Metformin HCL)

Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)

Sutent (Sunitinib Malate)

Synagis (palivizumab)

Tarceva (Erlotinib)

Victoza (liraglutide [rDNA])

Votrient (Pazopanib)

Xgeva (Denosumab)

Yasmin (Drospirenone and Ethinyl Estradiol)

Yaz (Drospirinenone and Ethinyl Estradiol)

Zegerid (Omeprazole and Sodium Bicarbonate) 

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