News You Can Use… Stacey Karl, PharmD Pete Koval, PharmD Cone Health Family Medicine January 2016

New Drug Approval Basaglar ® (insulin glargine) gained FDA approval for treatment of type 1 and type 2 diabetes First insulin product approved through an abbreviated approval pathway Trials proved that it was sufficiently similar to Lantus (insulin glargine) 12/16/2015 FDA.gov

New Drug Approval Zurampic ® (lesinurad) gained FDA approval for treatment of hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor Inhibits uric acid reabsorption in the kidney Most common side effects include headache, increased SCr, and GERD 12/22/2015 FDA.gov

New Drug Approval QuilliChew ® (methylphenidate ER) gained FDA approval for treatment of ADHD in patients ages 6 years old and above First and only long-acting chewable methylphenidate treatment Strengths: 20, 30, and 40 mg tablets 12/07/2015 Pfizer.com

New Drug Approval Uptravi ® (selexipag) gained FDA approval for treatment of Pulmonary Arterial Hypertension (PAH) Oral IP prostacyclin receptor agonist Common side effects: headache, diarrhea, jaw pain, nausea/vomiting, myalgia, painful extremities, and flushing 12/22/2015 FDA.gov

New Indication Pradaxa ® (dabigatran) gained FDA approval for the prevention of DVT and PE in patients undergoing hip replacement surgery Also approved for treatment of PE/DVT, to lower the risk of recurrent PE/DVT in those previously treated, and to reduce the risk of stroke or systemic embolism in AFib 11/24/2015 Medscape.com

Expanded Indication Gardasil 9 ® (Human Papillomavirus 9- valent Vaccine, Recombinant) gained FDA approval for the prevention of anal cancer and genital warts in males 16 through 26 years old Already approved for use in boys years old for the prevention of these diseases 12/15/2015 Merck.com

REMS Program Lifted The FDA is lifting the REMS program for Avandia ® (rosiglitazone) and combination products FDA reports that the REMS is no longer necessary to ensure that the benefits of the drug outweigh its risks 12/16/2015 FDA.gov

New Guidelines The CDC has posted new opioid guidelines open for public comment until January 13, 2016 The guidelines recommend against opioid therapy for chronic pain and prefer nonpharmacologic treatment and nonopioid treatment 12/14/2015 CDC.gov

New Study A new study compared azithromycin vs doxycycline for urogenital chlamydia due to concern for decreased efficacy with azithromycin Azithromycin was 97% effective and doxycycline was 100% in patients receiving directly observed therapy Both still appropriate treatment options 12/24/2015 NEJM.com