Dimethyl Fumarate (Tecfidera): A New Oral Agent for Multiple Sclerosis

Objective: To describe the clinical evidence supporting the safety, efficacy, and clinical utility of oral dimethyl fumarate for the treatment of multiple sclerosis (MS). Data Sources: A comprehensive PubMed search was conducted in July 2013 using the search terms dimethyl fumarate and Tecfidera. Reference lists of abstracted publications were reviewed to identify relevant works that were not retrieved via the electronic search. Additional information was obtained from the FDA Web site, manufacturer prescribing information, and Clinicaltrials.gov. Study Selection and Data Abstraction: Clinical trials and review articles that included the use of dimethyl fumarate in the treatment of MS and were available in English were abstracted for review. Data Synthesis: The safety and efficacy of dimethyl fumarate for the treatment of relapsing remitting MS was confirmed in 2 phase III trials, DEFINE and CONFIRM. Relative to placebo, twice-daily dimethyl fumarate was found to reduce the proportion of patients with relapses at 2 years by 34% to 49% and the annualized relapse rate by 44% to 53%. Although the incidence of serious adverse effects did not differ from that of placebo, intolerable flushing and gastrointestinal adverse effects prompted discontinuation in 3% and 4% of patients, respectively. Conclusions: In March 2013, dimethyl fumarate was approved as a third oral option for patients with relapsing forms of MS. Although no head-to-head trials have been conducted, a comparison of data from phase III trials suggests that the efficacy of dimethyl fumarate is comparable to that of existing oral agents and may offer a preferable safety profile

Levomilnacipran (Fetzima): A New Serotonin-Norepinephrine Reuptake Inhibitor for the Treatment of Major Depressive Disorder

In July 2013, the US Food and Drug Administration approved levomilnacipran extended release (ER; Fetzima), a serotonin-norepinephrine reuptake inhibitor, for the treatment of adults with major depressive disorder. Levomilnacipran is an active enantiomer of the racemic drug milnacipran that is currently approved in the United States for the treatment of fibromyalgia. This article provides an overview of the mechanism of action, pharmacokinetic properties, clinical efficacy, safety, and tolerability of levomilnacipran ER. Relevant information was identified through a search of databases using the key word levomilnacipran. Additional information was obtained from fda.gov, by a review of the reference lists of identified articles, and from posters and abstracts from scientific meetings. Levomilnacipran ER, dosed once daily, is generally well tolerated and has demonstrated favorable effects compared to placebo in clinical trials of patients with major depressive disorder. The increased potency for norepinephrine reuptake inhibition is a characteristic that may represent a novel contribution for levomilnacipran. Additional studies comparing levomilnacipran ER to other commonly prescribed antidepressants are needed to further evaluate its place in therapy

Tasimelteon (Hetlioz™): A New Melatonin Receptor Agonist for the Treatment of Non-24-Hour Sleep-Wake Disorder

In January 2014, the US Food and Drug Administration approved tasimelteon (Hetlioz™), a melatonin-receptor agonist for the treatment of non-24-hour sleep–wake disorder. This article provides an overview of the mechanism of action, pharmacokinetic properties, as well as the clinical efficacy, safety, and tolerability of tasimelteon. Relevant information was identified through a comprehensive literature search of several databases using the key words tasimelteon, Non-24-hour Sleep–Wake disorder, Non-24, and melatonin. Further information was obtained from the tasimelteon package insert, fda.gov, clinicaltrials.gov, briefing materials provided by Vanda Pharmaceuticals, and posters from scientific meetings

Safety of Popular Herbal Supplements in Lactating Women

The increasing popularity and use of dietary supplements has required health care professionals to become more knowledgeable of their properties, interactions, and adverse effects. The objectives of this review were to evaluate the safety of popular dietary supplements in breastfeeding mothers and the effects on the infants. Nine of the most popular herbal dietary supplements were identified based on the 2011 US market report of the top 10 selling botanicals and the most frequently received inquiries by the Ruth A. Lawrence Lactation Study Center at the University of Rochester Medical Center. Relevant publications were identified through June 2014 using PubMed and EMBASE; tertiary references, including the Drugs and Lactation Database and Natural Medicine Comprehensive Database, were also reviewed. These herbals include black cohosh, cranberry, echinacea, evening primrose, garlic, ginseng, melatonin, milk thistle, and St John’s wort. Studies varied greatly with regard to study design, herbal intervention, and outcome measures. Findings suggested that dietary/herbal supplements have not been evaluated in high-quality clinical trials, and there is limited evidence supporting safety of use, particularly among lactating women. Therefore, it is essential for physicians to provide counseling for nursing mothers seeking information on dietary supplements, highlighting reliable safety profiles, inquiring about the potential benefits the patient is seeking, and assessing the patient’s perception of this supplement during breastfeeding. More research and clinical trials are required in this area to guide the recommendations and expand our current knowledge of these products

Stinging Nettle (Urtica dioica): An Unusual Case of Galactorrhea

BACKGROUND: The increasing popularity and availability of herbal supplements among patients necessitates a better understanding of their mechanism of action and the effects they have on the body, both intended and unintended. Stinging nettle (Urtica dioica) is an herbaceous shrub found throughout the world that has been used for medicinal purposes for centuries. CASE REPORT: A 30-year-old woman with obesity and GERD presented to a primary care clinic with new-onset galactorrhea. A urine pregnancy test was negative. Prolactin, thyroid-stimulating hormone (TSH), and a metabolic panel were all within normal limits. A mammogram demonstrated scattered areas of fibroglandular density and benign-appearing calcifications in the left breast. The breast ultrasound showed no suspicious findings. Her medications included intermittent Echinacea, etonogestrel implant 68 mg subdermal, and the supplement stinging nettle 500 mg, which she had been taking over the past month for environmental allergies. After consultation with a clinical pharmacist, the stinging nettle was discontinued. No additional changes to her medications or supplements were made. One week after discontinuation, she returned to the clinic with complete resolution of the galactorrhea. CONCLUSIONS: Stinging nettle (Urtica dioica) is a common supplement and has effects on (1) sex hormone-binding globulin, (2) histamine-induced prolactin release, and (3) serotonin-induced release of thyrotropin-releasing hormone. The local estrogen bioactivity in breast tissue may subsequently lead to gynecomastia and/or galactorrhea. Supplements are an often overlooked but a critical component of medication reconciliation and potential clinical adverse effects