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The MedWatch August 2014 Safety Labeling Changes posting includes 32 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/ucm413266.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Adenoscan (adenosine) injection
Axert (almotriptan malate) Tablets
Elelyso (taliglucerase alfa) for injection
Eliquis (apixaban) tablets
Estring (estradiol vaginal ring)
Farxiga (dapagliflozin) tablets
Ifex (ifosfamide) for Injection
Inlyta (axitinib) tablets
Intelence (etravirine) tablets
Juxtapid (lomitapide) capsules
Keppra XR (levetiracetam) extended-release tablets
Nicorette (nicotine polacrilex) Gum9 [OTC]
Omnitrope (somatropin [rDNA origin] injection)
Pradaxa (dabigatran etexilate mesylate) capsules
Radiogardase (Prussian Blue Insoluble) capsules
Requip XL (ropinirole) tablet, extended release
Stavzor (valproic acid) Delayed Release Capsules
Sylatron (peginterferon alfa-2b) for injection
Vectibix (panitumumab) Injection
Vimpat (lacosamide) Oral Solution, Tablet, Injection
Zemplar (paricalcitol) capsules
Zohydro ER (hydrocodone bitartrate) extended-release capsules
Zyban (bupropion hydrochloride) Sustained-Release Tablets
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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