October 2011 Medication Label Changes

Last month brought changes to forty-eight (48) medical product labels (up from 34 changes in September), 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.

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New Medication Label Changes


For a complete detailed accounting of the label changes, please 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 drugs have been effected:

Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension
Evamist (estradiol transdermal spray)
Selzentry (maraviroc) Tablets
Demerol (meperidine hydrochloride)
Oral Hycamtin (topotecan) Capsules
Premarin (conjugated estrogens tablets, USP)
Suprenza (phentermine hydrochloride) ODT
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) Tablets
Avelox (moxifloxacin hydrochloride) Tablets and IV
Byetta (exenatide) injection
Clozaril (clozapine) Tablets
Ciprofloxacin Tablets
Ciprofloxacin IV for Inusion Vial
Ciprofloxacin 0.2 % Solution in 5% Dextrose
Ciprofloxacin Oral Suspension
Cipro XR Tablets
Factive (gemifloxacin mesylate) Tablets
Gallium Citrate Ga 67 Injection
Lactated Ringer’s injection in aviva plastic container
Lactated Ringer’s,
Lactated Ringer’s and 5% Dextrose
Sodium Lactate (M/6 sodium lactate) injections in viaflex plastic container
Levaquin (levofloxacin) Tablets
Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules
Lithobid (lithium carbonate) Extended-Release tablets
Nexavar (sorafenib)
Noroxin (norfloxacin) Tablets
OxyContin (oxycodone hydrochloride) Controlled-Release Tablets
Tasigna (nilotinib) Capsules
Veramyst, (fluticasone furoate) Nasal Spray
Votrient (pazopanib hydrochloride) Tablets
Vumon (teniposide) Injection
Vytorin (ezetimibe/simvastatin) Tablets
Zocor (simvastatin) Tablets

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