Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • June 17, 2011

    Ortho-McNeil-Janssen is initiating a voluntary recall of one lot of Risperdal (risperidone) 3 mg tablets (Lot #0GG904, Expiration Date May 2012, NDC #50458-330-06) and one lot of risperidone 2 mg tablets (Lot #0LG175, Expiration Date Aug 2012, NDC #50458-593-60 ), marketed by Patriot Pharmaceuticals. Both are packaged in bottles containing 60 tablets. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole (TBA). Although not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.

     

     

     

  • 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

    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

    Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip) have been reported, with some patients receiving the wrong medication and subsequently requiring hospitalization. FDA has determined that the factors contributing to the confusion between the two products include similarities of both the brand and generic names, similarities of the container labels and carton packaging, illegible handwriting on prescriptions, and overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals. The manufacturers of these products will be required to use "tall man" lettering on container labels and carton packaging to present the generic names as risperiDONE and rOPINIRole. In addition, changes to individual labels and carton packaging will allow for better visual differentiation between the generic products.

     

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