FDA: Safety Labeling Changes Made to Prescribing Information for 48 Products in October

The U.S. Food and Drug Administration has published safety labeling changes made prescribing information for 48 products in October.


Changes were made to boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert and medication guide.


The following drugs had modifications to the boxed warnings, contraindications and warnings sections:

  • 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


To view a listing of drug names and safety labeling sections revised, click here. Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.


Related Articles on Medication Safety:

Commentary: Anesthesiologists Should Take Active Role in Drug Safety, Shortages

7 Top Noncompliance Issues in Medication Management

Accepted & Recommended Process for Disposing Expired Medications: Q&A With Sheldon Sones of Sheldon S. Sones and Associates

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