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May 2013 Medication Safety Labeling Changes

May brought changes to forty (40) medical product labels (down from 48 changes in April), 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.

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

The following medications have been affected:

  • Codeine Sulfate Solution
  • Codeine Sulfate Tablets
  • Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
  • Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) Capsules
  • Promethazine and Codeine Syrup
  • Promethazine, Phenylephrine and Codeine Syrup
  • Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) Tablets
  • SynalgosDC (dihydrocodeine bitartrate, aspirin, and caffeine) Capsules
  • Vivelle-Dot (estradiol transdermal system)
  • Kombiglyze XR (saxagliptin + metformin XR FDC) tablets
  • Onglyza (saxagliptin)
  • Dyna-Hex 0.75 (chlorhexidine gluconate 0.75% solution)
  • Gemzar (Gemcitabine for injection), 1g and 200 mg
  • Humira (adalimumab)
  • Inspra (eplerenone) 25 mg and 50 mg Tablets
  • Magnesium Sulfate in dextrose 5 percent injection, USP
  • Magnesium Sulfate Injection, USP, 50 percent
  • Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container
  • Neoral Soft Gelatin Capsules (cyclosporine capsules, USP)
  • Neoral Oral Solution (cyclosporine oral solution, USP)
  • Rituxan (rituximab)
  • Sandimmune Injection (schizophrenics USP)
  • Sandimmune Oral Solution (cyclosporine USP)
  • Sandimmune Soft Gelatin Capsules (cyclosporine USP)
  • Tasmar (tolcapone) 100 mg Tablets
  • Tysabri (Natalizumab) injection
  • Yervoy (ipilimumab)