Medication Monitor

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  • 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.


  • May 31, 2011

    A safety communication released by FDA highlighted data from two recently published studies that reported a two- to three-fold greater risk of venous thromboembolic events in women taking oral contraceptives containing drospirenone as compared with those taking contraceptive therapy containing levonorgestrel. FDA noted that previous data have had conflicting results, with other studies not reporting any difference in the venous thromboembolic risk between drospirenone-containing products and products containing levonorgestrel or other progestins. The agency is reviewing these and other data and will communicate any new safety information as it becomes available.


  • May 27, 2011


    Treatment of fecal incontinence in adult patients who have failed previous therapies such as modifications in diet, fiber therapy, or antimotility medications 

    Solesta 1 mL injectable gel consists of dextranomer microspheres (50 mg/mL) and stabilized sodium hyaluronate (15 mg/mL) in a phosphate-buffered 0.9% sodium chloride solution. It is injected into the deep submucosal layer in the proximal part of the high pressure zone of the anal canal. A total of four submucosal injections are administered at each treatment session. The injections are designed to build up tissue in that area so that the opening of the anus narrows allowing patients to have better control of their muscles. Only physicians experienced in performing anorectal procedures and who have successfully completed the Solesta injection procedure training program can administer the gel.