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 FDA Safety Update Simvastatin • Fifty-two patients (0.9%) in the 80-mg group versus one patient (0.02%) in the 20-mg group developed myopathy (defined as unexplained muscle weakness or pain with a serum CK >10 times the upper limit of normal [ULN]). This was higher than the labeled risk (based on clinical trial data) of 0.53%. • Twenty-two patients (0.4%) in the 80-mg group versus no patient in the 20-mg group developed rhabdomyolysis (defined as unexplained muscle weakness or pain with serum CK >40 times ULN). • The risks for myopathy and rhabdomyolysis with simvastatin 80 mg were highest in the first 12 months of treatment, 5 per 1000 person-years and 2 per 1000 person-years, respectively, and decreased to 1 per 1000 person-years and 0.4 per 1000 person-years after that. FDA Safety Update Simvastatin 6-8-2011 FDA Safety Update • Based upon data from the SEARCH Trial the FDA is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage. • Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy). • Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 FDA Safety Update Simvastatin FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines. • Contraindicated with : Itraconazole, Ketoconazole, Posaconazole (New), Erythromycin, Clarithromycin, Telithromycin, HIV/HCV protease inhibitors, Nefazodone, Gemfibrozil (old 10mg), Cyclosporine (old 10 mg), and Danazol (old 10mg). • Maximum 10 mg simvastatin dose with: Amiodarone (old 20mg), Verapamil (old 20mg) and Diltiazem (old 40 mg). • Maximum 20 mg simvastatin dose with: Amlodipine (New) and Ranolazine (New) Varenicline Safety Update 6-16-2011 FDA safety update Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease FDA reviewed a randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease (other than, or in addition to, hypertension) that had been diagnosed at least two months prior to the screening visit. Patients were randomized to treatment with Chantix 1 mg twice daily (n=350) or placebo (n=350). The study consisted of a 12-week treatment period that was followed by a 40-week non-treatment period. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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