Monthly FDA Drug List with Safety Label Changes

[mainframetech]

For the full list, go to the website below:


From: FDA MedWatch
Date: 05/14/2012
Subject: FDA MedWatch - 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)

Chris