Download NEWS YOU CAN USE 2016 01 UPD

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 9 -15
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