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Mrx CLINICAL ALERT MRx AUGUST 2018 CLINICAL ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS HOT TOPIC: potential to placebo in non-dependent FIRST DRUG COMPRISED adult recreational drug users. EDITORIAL OF ACTIVE MARIJUANA DERIVATIVE APPROVED Cannabidiol oral solution was studied STAFF in 3 randomized, double-blind, placebo- Under Priority review, the United States controlled clinical trials including 516 (US) Food and Drug Administration (FDA) patients with either LGS or Dravet EDITOR IN CHIEF approved cannabidiol oral solution syndrome. Cannabidiol taken with ® Maryam Tabatabai (Epidiolex ) for the treatment of the patient’s current anticonvulsant PharmD seizures associated with Lennox-Gastaut regimen was shown to be effective syndrome (LGS) or Dravet syndrome in in reducing the frequency of seizures patients ≥ 2 years of age. It is the only when compared with placebo. Over EXECUTIVE EDITOR drug approved to treat Dravet syndrome the 12-week treatment period, the Carole Kerzic and the FDA designated it as an Orphan reduction in median number of LGS RPh drug and Rare pediatric disease drug seizures ranged from 37% to 44% with to treat both serious, difficult-to-treat CBD and 17% to 22% with placebo. DEPUTY EDITORS childhood seizure disorders. Dravet For Dravet syndrome, seizure reductions Stephanie Christofferson syndrome is diagnosed in approximately were 39% and 13% with CBD and PharmD 1 in 15,700 individuals in the US and placebo, respectively. Common side is characterized by frequent prolonged effects (≥ 10%) reported with CBD Jessica Czechowski seizures and developmental delays. LGS were increased liver transaminases PharmD involves frequent drop seizures and (particularly with concurrent use of impaired intellectual development. It valproate and clobazam), somnolence, Lara Frick accounts for 2% to 5% of childhood decreased appetite, diarrhea, rash, PharmD, BCPS, BCPP seizure disorders. LGS is typically fatigue, insomnia, and infections. first seen between the ages of 3 to Epidiolex must be dispensed with a Leslie Pittman 5 years and persists into adulthood. patient Medication Guide that describes PharmD Other medications approved to treat important information about the drug’s LGS include clobazam, clonazepam, uses and risks. felbamate, lamotrigine, rufinamide, and topiramate. Under the Controlled Substances Act, CBD is a Schedule I controlled substance Cannabidiol (CBD) oral solution is the because it is a chemical component first agent to garner FDA approval that of the cannabis plant. Availability of contains a purified drug substance Epidiolex is anticipated after the US Drug derived from marijuana. While CBD Enforcement Administration (DEA) has is a cannabinoid found in marijuana, made a scheduling determination for it is not the primary psychoactive the product, which is expected to take component, nor is it associated with place within 90 days of drug approval. intoxication or euphoria, as seen with tetrahydrocannabidiol (THC). Studies demonstrated CBD has a similar Download at: drug-liking and physical dependence magellanrx.com | AUGUST 2018 FDA ISSUES STRONGER CDC now recommends the 3HP regimen be administered FLUOROQUINOLONE WARNINGS by DOT or self-administered therapy (SAT) in patients ≥ 2 years of age. The CDC acknowledges that additional The FDA is strengthening warnings for all systemic studies are needed to understand the pharmacokinetics, fluoroquinolone antibiotics related to the risks of significant safety, and tolerance of 3HP in patients ages < 2 years; hypoglycemia and certain mental health side effects. A adherence and safety of 3HP-SAT among patients < 18 recent FDA review identified 56 cases of hypoglycemic years of age; and safety of 3HP during pregnancy. coma associated with fluoroquinolone use during October 1987 to April 2017. Most patients had risk factors for GUIDELINE UPDATE ON OSTEOPOROSIS hypoglycemia (e.g., older age, diabetes, renal impairment). Based on this new information, hypoglycemic coma will SCREENING be added to the label’s existing warnings regarding blood Osteoporotic fractures are associated with multiple negative glucose disturbances. outcomes including limitations in ambulation, chronic pain, disability, loss of independence, and decreased The Agency also found inconsistent labeling regarding quality of life. With the aging population in the US, the psychiatric effects among fluoroquinolone agents. The prevalence of primary osteoporosis will likely increase FDA is requiring that labels of all systemic agents include to approximately 12.3 million Americans > 50 years of the following psychiatric adverse effects: disorientation, age by the year 2020. Higher rates of osteoporosis and disturbances in attention, delirium, memory impairment, osteoporotic fractures occur in women compared to men; agitation, and nervousness. The FDA warns that psychiatric however, fracture-related mortality is higher among men. adverse reactions may occur after just one dose. Osteoporosis is generally asymptomatic until a fracture occurs; therefore, screening for osteoporosis is the most Fluoroquinolone treatment should be discontinued if effective tool in preventing osteoporotic fractures. patients report any central nervous system (CNS) side effects or blood glucose disturbances. Switching to a In an effort to decrease preventable burden, the US non-fluoroquinolone antibiotic should be considered if Preventive Services Task Force (USPSTF) released updated possible. Fluoroquinolones should not be prescribed to guidelines regarding osteoporosis screening to prevent treat acute bacterial sinusitis, acute bacterial exacerbations fractures. They recommend screening for osteoporosis of chronic bronchitis, and uncomplicated urinary tract with bone measurement testing in all women aged ≥ 65 infections (UTIs) if patients have other treatment options years and in postmenopausal women < 65 years who are because the risks outweigh the benefits in these patients. considered to be at increased risk of osteoporosis by a clinical risk assessment tool (Level B recommendations). CDC UPDATES RECOMMENDATIONS FOR Evidence is convincing to support the use of subsequent LATENT TUBERCULOSIS TREATMENT drug therapies to reduce fracture rates in postmenopausal women. A similar effect cannot be presumed to occur in The Centers for Disease Control and Prevention (CDC) men; therefore, the USPSTF concludes that the current updated their recommendations on the treatment of evidence is insufficient to determine the benefit of latent tuberculosis infection (LTBI). In 2011, the CDC osteoporosis screening on fracture prevention in men. recommended once-weekly isoniazid and rifapentine for 12 weeks (3HP) administered by directly observed therapy USPSTF states there is compelling evidence that bone (DOT); however, this regimen was not recommended for measurement tests are accurate for predicting osteoporotic use in children < 12 years of age or for patients with fractures. Central dual-energy X-ray absorptiometry (DXA) human immunodeficiency virus-1 (HIV-1) infection. that measures bone mineral density (BMD) of the hip and In 2017, a CDC Work Group conducted a systematic lumbar spine is most commonly used to define osteoporosis review and meta-analysis of the 3HP regimen and and guide treatment initiation. Risk assessment tools with determined that it is as safe and effective as other moderate accuracy in predicting osteoporosis and related recommended LTBI regimens and achieves significantly fractures include: the Simple Calculated Osteoporosis higher treatment completion rates. As a result, the CDC Risk Estimation (SCORE), Osteoporosis Risk Assessment now recommends 3HP for treatment of LTBI in patients Instrument (ORAI), Osteoporosis Index of Risk (OSIRIS), ≥ 2 years of age and in patients with HIV-1 infection or Osteoporosis Self-Assessment Tool (OST), and the Fracture acquired immunodeficiency syndrome (AIDS) who are Risk Assessment Tool (FRAX®). Screening interval may taking antiretroviral medications with acceptable drug- be based on age, baseline BMD, and projected time to drug interaction profiles with rifapentine. Additionally, the osteoporosis development. 2 | AUGUST 2018 DRUG INFORMATION HIGHLIGHTS • The nationwide shortage of epinephrine auto-injectors, for • Two vaccines for the prevention of herpes zoster (shingles) the emergency treatment of allergic reactions, including are available in the US for use in people aged ≥ 50 anaphylaxis, appears to be subsiding. While Impax’s years. They include a live attenuated virus vaccine authorized generic (AG) version of the discontinued (Zostavax®), administered as a single subcutaneous Adrenaclick® continues to be on backorder, Mylan (SC) dose, and a recombinant zoster vaccine (Shingrix®), reports that they are shipping large amounts of Epipen® which is administered as a 2-dose intramuscular (IM) 0.3 mg, Epipen Jr® 0.15 mg, and their respective AGs, series, with the second dose given anytime from 2 to to distributors. No shortages are reported for Kaleo’s 6 months after the first. During the 4 months following Auvi-Q® 0.3 mg, 0.15 mg, and 0.1 mg. Adamis’ Symjepi® the introduction of Shingrix in October 2017, the CDC 0.3 mg, FDA-approved in June 2017, has not entered received 13 reports of administration errors involving the US market; further, approval of the 0.15 mg version Shingrix. Errors included incorrect route of administration, of Symjepi is expected in September 2018. inappropriate age of recipient, patient receipt of vaccine • The FDA announced a voluntary recall of several
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