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February 2014 Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information
The MedWatch February 2014 Safety Labeling Changes posting includes 35 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 product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm388717.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Promacta (eltrombopag)
Nizoral (ketoconazole)
Bravelle (urofollitropin for injection, purified)
Juvisync (sitagliptin and simvastatin)
Menopur (menotropins for injection)
Mevacor (lovastatin)
Samsca (tolvaptan)
Vytorin (ezetimibe/simvastatin)
Zocor (simvastatin)
Afinitor (everolimus)
Afinitor Disperz (everolimus tablets for oral suspension)
Agrylin (anagrelide hydrochloride)
Aloxi (palonosetron hydrochloride)
Astagraf XL (tacrolimus extended-release capsules)
Imuran (azathioprine)
Lodosyn (carbidopa)
Simponi Aria (golimumab)
Victrelis (boceprevir)
Zelboraf (vemurafenib)
Biltricide (praziquantel)
Juxtapid (lomitapide)
Nexium (esomeprazole magnesium)
Nexium I.V. (esomeprazole sodium)
Prilosec (omeprazole)
Prilosec (omeprazole magnesium)
Vimovo (naproxen/esomeprazole magnesium)
Xarelto (rivaroxaban)
Zegerid (omeprazole/sodium bicarbonate)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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