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The MedWatch October 2015 Safety Labeling Changes posting includes 26 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm471840.htm
The following drugs had modifications to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections:
Atropine Sulfate Injection
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Eloxatin (oxaliplatin) Injection, for Intravenous Use
INOmax (nitric oxide) for Inhalation
Jadenu (deferasirox) Tablets
Letairis (ambrisentan) Tablets
Mirena (levonorgestrel-releasing intrauterine system)
Myfortic (mycophenolic acid) Delayed-release Tablets
Nicoderm CQ (nicotine transdermal system)
Opdivo (nivolumab) Injection
Ortho Evra (norelgestromin and ethinyl estradiol transdermal patch)
Ortho-Novum Tablets (norethindrone/ethinyl estradiol) Tablets and Modicon 28 Tablets (norethindrone/ethinyl estradiol)
Picato (ingenol mebutate) Gel
Pradaxa (dabigatran etexilate mesylate) Capsules
Technnivie (ombitasvir, paritaprevir, and ritonavir) Tablets
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use
Yervoy (ipililumab) Injection
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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