New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
2 nd Annual Essentials in Primary Care<br />
Fall Conference<br />
Friday, November 11, <strong>2011</strong><br />
FDA Safety <strong>Update</strong> Simvastatin<br />
FDA is requiring changes to the simvastatin label to add new<br />
contraindications (should not be used with certain medications)<br />
and dose limitations for using simvastatin with certain<br />
medicines.<br />
• Contraindicated with : Itraconazole, Ketoconazole,<br />
Posaconazole (<strong>New</strong>), Erythromycin, Clarithromycin,<br />
Telithromycin, HIV/HCV protease inhibitors, Nefazodone,<br />
Gemfibrozil (old 10mg), Cyclosporine (old 10 mg), and Danazol<br />
(old 10mg).<br />
• Maximum 10 mg simvastatin dose with: Amiodarone (old<br />
20mg), Verapamil (old 20mg) and Diltiazem (old 40 mg).<br />
• Maximum 20 mg simvastatin dose with: Amlodipine (<strong>New</strong>)<br />
and Ranolazine (<strong>New</strong>)<br />
Varenicline Safety <strong>Update</strong><br />
6-16-<strong>2011</strong> FDA safety update Chantix (varenicline) may increase<br />
the risk of certain cardiovascular adverse events in patients with<br />
cardiovascular disease<br />
FDA reviewed a randomized, double-blind, placebo-controlled<br />
clinical trial designed to assess the efficacy and safety of Chantix<br />
for smoking cessation in 700 patients aged 35 to 75 years with<br />
stable, documented cardiovascular disease (other than, or in<br />
addition to, hypertension) that had been diagnosed at least two<br />
months prior to the screening visit. Patients were randomized to<br />
treatment with Chantix 1 mg twice daily (n=350) or placebo<br />
(n=350). The study consisted of a 12-week treatment period that<br />
was followed by a 40-week non-treatment period.<br />
Wayne Weart<br />
<strong>New</strong> <strong>Drug</strong> <strong>Update</strong> Part I