New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Colchicine • September 30, 2010 FDA notified companies to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. • Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. Approved by the FDA in 2009, Colcrys’ prescribing information contains important safety data and recommendations on drug interactions and dosing not available with unapproved products – Max dose 3 x 0.6 mg tabs per acute attack (NOT 4.8 mg total dose) – Colchicine is a substrate for CYP 3A4 and efflux pumps (P-glycoprotein) Immunization Update October 28, 2010 ACIP Recommends Tdap for patients 65 y/o and older • Tdap can replace Td in adults aged 65 years and older in those who have not previously received Tdap. In addition, adults aged 65 years or older who anticipate contact with children aged 12 months or younger should also be vaccinated to protect both themselves and the infant. • Tdap vaccine was not licensed for use in adults aged 65 years or older until 7/8/2011; however, data from the Vaccine Adverse Event Reporting System suggest that the "safety profile of Tdap vaccine in these adults is as safe as the Td vaccine." • "Tdap can be administered regardless of interval since the last tetanus or diphtheria containing vaccines." Wayne Weart New Drug Update Part I
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
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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