Medication Monitor

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  • 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).

  • June 5, 2011

    FDA issued an alert that SimplyThick should not be given to premature infants because the product may cause necrotizing enterocolitis (NEC). Specifically, SimplyThick should not be given to infants born before 37 weeks' gestation who are currently receiving hospital care or have been discharged from the hospital within the past 30 days. The agency is currenlty aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.

    On June 4, SimplyThick voluntarily recalled its thickening gel product manufactured at its Stone Mountain, GA, plant. SimplyThick's recall of this product is a result of the company's failure to ensure that harmful bacteria of possible public health significance were destroyed in the manufacturing process at that manufacturing plant. Product manufactured at other facilities remains on the market.


  • June 4, 2011

    Hundreds of drug products repackaged for hospital inpatients by Aidapak Services have been recalled because of the possibility of contamination of nonpenicillin products with beta-lactam antibiotics, FDA said. A 317-page PDF lists the affected products and lots. These include all repackaged products from this company.

    Patients with hypersensitivities to penicllins or cephalosporins are at risk of reactions if exposed to cross-contaminated products.

  • June 2, 2011

    The results of FDA’s comprehensive trial-level meta-analysis of data from 31 trials involving approximately 156,000 patients showed that patients taking an ARB did not have an increased risk of cancer, compared with those on non-ARB therapy. FDA found no evidence of an association between ARBs and cancer-related death, breast cancer, lung cancer, or prostate cancer. In July 2010, FDA stated that it would conduct this review after a published meta-analysis of 5 randomized clinical trials reported a small but statistically significant increase in the risk of cancer in patients taking ARBs.