New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Immunization Update
• December 22, 2010 HPV Vaccine – Gardasil UPDATE The FDA
approved vaccination in people ages 9 through 26 years for
the prevention of anal cancer and associated precancerous
lesions due to human papillomavirus (HPV) types 6, 11, 16,
and 18. Gardasil was studied in a randomized, controlled trial
of men who self-identified as having sex with men (MSM).
This population was studied because it has the highest
incidence of anal cancer. At the end of the study period,
Gardasil was shown to be 78 percent effective in the
prevention of HPV 16- and 18-related AIN. Because anal
cancer is the same disease in both males and females, the
effectiveness data was used to support the indication in
females as well. (N Engl J Med 2011; 364:401-411)
PPI’s and Fracture Risk
• May 25, 2010 FDA Safety Alert PPI’s and Fracture Risk FDA is
revising the prescription and over-the-counter (OTC) labels for
a class of drugs called proton pump inhibitors to include new
safety information about a possible increased risk of fractures
of the hip, wrist, and spine with the use of these medications.
– Six epidemiological studies that reported an increased risk of fractures
of the hip, wrist, and spine with proton pump inhibitor use. Some
studies found that those at greatest risk for these fractures received
high doses of proton pump inhibitors or used them for one year or
more. The majority of the studies evaluated individuals 50 years of age
or older and the increased risk of fracture primarily was observed in
this age group.
– Individuals at risk for osteoporosis should have their bone status
managed according to current clinical practice, and should take
adequate vitamin D and appropriate calcium supplementation. (IE a
soluble calcium salt like calcium citrate)
Wayne Weart
New Drug Update Part I