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August 2013 Medication Safety Labeling Changes

August brought changes to thirty-four (34) medical product labels, with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

pillsFor a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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