MedWatch August 2013 Safety Labeling Changes


The MedWatch August 2013 Safety Labeling Changes posting includes 34 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: 

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections: 


Ablavar (Gadofosveset Trisodium) Injection
Aerospan (flunisolilde) Inhalation Aerosol
Avelox (Moxifloxacin Hydrochloride) Tablets and Injection
Cipro (Ciprofloxacin Hydrochloride) Tablets and Oral Suspension
Cipro IV (Ciprofloxacin Hydrochloride) Injection
Cipro XR (Ciprofloxacin extended-release) Tablets
Colyte (Peg-3350 & electrolytes) For oral solution
Crestor (Rosuvastatin Calcium) Tablets
Daliresp (Roflumilast) Tablets
Desoxyn (Methamphetamine Hydrochloride) Tablets
Doxil (Doxorubicin HCL) Liposome Injection
Factive (Gemifloxacin Mesylate) Tablets
Levaquin (Levofloxacin) Tablets, Oral Solution and Injection
Lialda (Mesalamine) Delayed-release Tablets
Mirena (Levonorgestrel-Releasing Intrauterine System)
Noroxin (Norfloxacin)
Letairis (Ambrisentan) Tablets
Omniscan (Gadodiamide) Injection
Optimark (Gadoversetamide) Injection
Quillivant XR (Methylphenidate) Extended-release Oral Suspension
Relistor (Methylnaltrexone Bromide) Subcutaneous Injection
Skyla (Levonorgestrel-Releasing Intrauterine System)
Strattera (Atomoxetine Hydrochloride) Capsules
Sutent (Sunitinib Malate) Capsules
Votrient (Pazopanib) Tablets
Xarelto (Rivaroxaban) Tablets
Xgeva (Denosumab) Injection
Zevalin (Ibritumomab Tiuxetan) Injection


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