NMA: Nonprescription Medicines Academy

Quick Takes

October 17th, 2012

  • Oxytrol (oxybutynin transdermal system) could become the first nonprescription medication for the treatment of overactive bladder in women. The FDA Nonprescription Drugs Advisory Committee will consider the Rx-to-OTC switch application during its November 9 meeting. The proposed OTC product would be called Oxytrol for Women.
  • A Cochrane systematic review of 16 studies involving 2,027 women found insufficient evidence to support the use of black cohosh (Cimicifuga racemosa or Actaea racemosa) for controlling symptoms of menopause. All studies used oral monopreparations of black cohosh at a median daily dose of 40 mg, for a mean duration of 23 weeks. Comparisons of the effectiveness of black cohosh and other interventions (including hormone therapy, red clover, fluoxetine, and placebo) were either inconclusive (because of considerable heterogeneity or an insufficient number of studies) or not statistically significant. Evidence of the safety of black cohosh also was inconclusive. However, the authors did find adequate justification for conducting further studies in this area. (Cochrane Database Syst Rev. 2012 Sep 12;9:CD007244.)
  • In a randomized, double-blind, placebo-controlled clinical trial that included 52 women with major depressive disorder, concurrent administration of the dietary supplement creatine monohydrate 5 g/day was associated with more rapid antidepressant efficacy of the selective serotonin uptake inhibitor escitalopram, as assessed by changes in the Hamilton Depression Rating Scale (HAM-D) score. Improvements were seen as early as week 2 of treatment; there was no difference between groups in the overall frequency of all reported adverse events. The authors cautioned that replication of the current findings is required in larger study groups and with a longer period of observation. (Am J Psychiatry.2012;169:937-45.)
  • An early release article available on the Annals of Emergency Medicine website reviews the best available evidence on the use of topical antibiotics for acute, minor, uncomplicated soft tissue wounds. After evaluating four randomized, controlled clinical trials—two that focused on repaired wounds and two that focused on minor wounds in children—the authors concluded that topical antibiotics do reduce the infection rate, with a low incidence of contact hypersensitivity. (Ann Emerg Med. 2012 Sep 7. [Epub ahead of print])
  • In a nationwide cohort of more than 99,000 patients in Denmark with first-time myocardial infarction (MI), the use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with persistently increased coronary risk regardless of time elapsed after MI. Specifically, the risk of (1) all-cause death and (2) the combined endpoint of death caused by coronary artery disease or readmission for nonfatal MI remained virtually unchanged throughout all 5 years after discharge from hospital following the first MI. According to the authors, the results support previous findings that NSAIDs have no apparent safe treatment window among patients with MI. (Circulation. 2012 Sep 10. [Epub ahead of print])
  • An analysis of data from 84,602 postmenopausal women in the Nurses’ Health Study cohort found that the use of aspirin, other NSAIDs, or acetaminophen was not importantly associated with the incidence of breast cancer—either overall or by hormone receptor subtype—during 28 years of follow-up. No consistent, significant associations were observed with any of several specific tumor molecular subtypes; the associations also did not vary substantially by body mass index, alcohol consumption, postmenopausal hormone use, or family history of breast cancer. (J Clin Oncol. 2012;30:3468-77. Epub 2012 Aug 27.)
  • The HealthMap.org website based at Children’s Hospital Boston now offers a vaccine finder at the URL http://flushot.healthmap.org/. Visitors who type in their address will receive a list of local locations that offer flu vaccines, including information about which types of vaccines are available (e.g., intradermal, high dose), operating hours, and minimum age requirements. Providers of flu vaccines can join the database at https://flushot.healthmap.org/admin/signup/.
  • The October 2012 issue of Pediatrics includes a policy statement from the American Academy of Pediatrics (AAP) Committee on Infectious Diseases with updated recommendations for prevention and control of influenza in children. The AAP recommends annual trivalent seasonal influenza immunization for all children and adolescents 6 months of age and older; the policy statement includes an updated dosing algorithm for administration of influenza vaccine to children 6 months to 8 years of age. (Pediatrics. 2012; 130:780-92. Epub 2012 Sep 10.)