Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • June 13, 2011

    Bedford Laboratories initiated a nationwide voluntary recall of indomethacin for injection, 1 mg single dose vial, Lot #1948138, Expiration Date September 2011, NDC #55390-299-01. This voluntary recall was initiated because some of the vials in this lot number may contain particulate matter. Out-of-specification results were obtained for particulate matter ≥ 10 micron. The product did meet specification for particulate matter ≥ 25 micron. The particulate matter has been identified as active drug substance and not foreign material or contamination. The product was distributed to wholesalers and distributors nationwide.

      

  • June 13, 2011

    Uses:

    Adjunctive treatment of partial-onset seizures in adults 

    Ezogabine is the first neuronal potassium channel opener approved for the management of patients with epilepsy. Activation of potassium currents mediated by the KCNQ family of ion channels results in stabilization of the resting membrane potential and a reduction in brain excitability. Patients randomized to total daily maintenance ezogabine dosages of 600 mg/d, 900 mg/d, or 1,200 mg/d had significant reductions in seizure frequency over a 28-day period, compared with placebo. According to a press release by Valeant and GlaxoSmithKline, the drug will not be available until later this year because FDA has recommended that the drug be classified as a controlled substance due to its euphoric effects. Final classification is still under review by the Drug Enforcement Administration.    

  • June 10, 2011

    FDA has approved Merck’s redesigned drug container labels that were developed under Merck’s Label Standardization Project. The labels will include a new standardized format to improve readability and provide better information on product and strength differentiation. The project includes the revision of 34 container labels for 16 oral products. The drugs affected include Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.

     

  • June 9, 2011

    FDA is alerting health care providers that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about an increased risk of being diagnosed with a high-grade prostate cancer. Data from the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) showed an increased incidence of high-grade prostate cancer with use of finasteride 5 mg/d for 7 years and dutasteride 0.5 mg/d for 4 years.

     

  • June 9, 2011

    Simvastatin dosage restrictions have been announced by FDA, along with additional contraindications concerning use of the drug with certain other medications or above certain doses with other drugs. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of myopathy, FDA said. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug, the agency added. FDA said simvastatin should never be used with posaconazole, and it moved three drugs from a "do not exceed simvastatin 10 mg" category to an absolute contraindication (gemfibrozil, cyclosporine, and danazol). Dosing limits for simvastain were lowered for amiodaraone, verapamil, and diltiazem (now 10 mg daily) and added for amlodipine and ranolazine (Ranexa—Gilead) (20 mg daily).

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