FDA MedWatch - October 2015 Drug Safety Labeling Changes includes 26 products with revisions to Prescribing Information

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