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News You Can Use… Ethan Hammer, PharmD Candidate Pete Koval, PharmD Cone Health Family Medicine August, 2016
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New Drug Approval Repatha ® (evolovumab) Pushtronex is the first single month PCSK9 inhibitor injection Indicated for treatment of hyperlipidemia Repatha lowered LDL ~71% when added to highest dose statin Previous dosage form: Repatha ® SureClick ® Autoinjector 140mg every 2 weeks http://www.amgen.com/media/news-releases/2016/07/fda-approves-first-and-only-single-monthly-injection-for-a-pcsk9-inhibitor/
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New Drug Approval Xiidra ® (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist Indicated for the treatment of the signs and symptoms of dry eye disease (DED) One drop twice daily in each eye (12h apart) Likely to compete w/ Restasis ® (cyclosporine) Restasis ® lacks Xiidra’s full dry eye label - indicated for “tear production” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510720.htm
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New Drug Approval Adlyxin ® (lixisenatide) GLP receptor agonist Indicated for DM – type 2 Once daily Will join exenatide (Byetta/Bydureon), liraglutide (Victoza), Dulaglutide (Trulicity), Albiglutide (Tanzeum) in the GLP market http://products.Sanofi.US/adlyxin/adlyxin.pdf
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Drug Approved for OTC Differin ® Gel (adapalene gel) 0.1% indicated acne now OTC First retinoid acne medication approved for OTC Approved for use in people >12y http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm
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Drug Prices EpiPens have become “expensive” Prices of EpiPens have increased from $100 in 2004 to $600 in 2016 It is now common for EMTs to use a 1mg vial of epinephrine and syringe http://www.ems1.com/ems-management/articles/2085712-Wash-EMTs-using-cheaper-Epi-Kit-instead-of-EpiPen/
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Inappropriate Prescribing Study Inappropriate prescribing (misuse and underuse) in patients >80 lead to an increases in: mortality rate 8.9% hospitalization rate 31% Patients are at an increased risk of mortality and hospitalization for every additional underused medication Wauters, M. et al. Too many, too few or too unsafe? Impact of inappropriate prescribing on mortality, and hospitalization in a cohort of community-dwelling oldest old. BJCP. July 18, 2016
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FDA Warnings – Quinolones Fluoroquinolones used systemically are associated with disabling and potentially permanent serious side effects that involve: tendons, muscles, joints, nerves, and CNS FDA Black Box Warning advises that the serious side effects outweigh the benefits for acute sinusitis, acute bronchitis, and uncomplicated UTIs who have other treatment options http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm
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