Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • June 16, 2011

    According to FDA, new safety information will be added to Warnings and Precautions section of the varenicline label describing a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. In addition, the patient Medication Guide will be revised to inform patients about this possible risk. A review of data from a randomized, controlled trial involving 700 patients showed that more patients treated with varenicline compared with placebo had events such as angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.

     

  • June 15, 2011

    Uses:

    Prophylaxis of organ rejection in adult patients receiving kidney transplant

    Belatacept works by binding to CD80 and CD86 on antigen-presenting cells, thereby blocking CD28-mediated costimulation of T lymphocytes. This is beneficial because activated T lymphocytes are the predominant mediators of immunologic rejection.

    Belatacept is administered as an intermittent I.V. infusion and given with basiliximab induction, mycophenolate mofetil, and corticosteroids. Data from two Phase III trials show that the overall efficacy of belatacept was similar to that of cyclosporine at 1 and 3 years. Patients treated with belatacept had superior renal function. Because of its immunosuppressing effects, belatacept is associated with many of the serious adverse reactions common with these agents, including infections and malignancies.

  • June 15, 2011

    American Regent is conducting a voluntary nationwide recall of concentrated sodium chloride injection, 23.4%, 30 mL Single Dose Vial, Lot #0362, Expiration Date May 2012, NDC #0517-2930-25, and of methyldopate injection, 250 mg/5 mL (50 mg/mL), 5 mL single dose vial, Lot #0152, Expiration Date March 2012, NDC #0517-8905-10. These recalls were initiated because some of the vials in these lots contain visible particulates. For the methyldopate injection, some of the vials of this lot contained translucent visible particles consistent with glass delamination. The glass particles (flakes) ranged in size from <50 microns to 200 microns. Both products were distributed to wholesalers and distributors nationwide.

     

  • June 15, 2011

    A safety communication has been released by FDA that use of pioglitazone for more than 1 year may be associated with an increased risk of bladder cancer. This information is based FDA's review of data from a planned 5-year interim analysis of an ongoing, 10-year epidemiological study of pioglitazone use. The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone and in those exposed to the highest cumulative dose of the drug. An epidemiological study conducted in France also suggested that use of pioglitazone was associated with an increased risk of bladder cancer, prompting that country to suspend the use of this agent. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines, and the patient Medication Guide will be revised to include information on the risk of bladder cancer. FDA noted that it will continue to evaluate data from the ongoing 10-year epidemiological study and conduct a comprehensive review of the results from the French study; updated information will be released when it becomes available.

     

  • 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.    

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