PHARM.D

Varenicline May Raise CV Events in CVD Patients Michael O'Riordan The smoking-cessation drug varenicline (Chantix, Pfizer) may be associated with a small increased risk of cardiovascular events in patients with cardiovascular disease, according to the Food and Drug Administration (FDA) [1]. The new safety communication, which will be added to the warnings and precautions section of the drug's label, states that physicians need to balance the known benefits of varenicline--a drug effective in helping patients quit smoking--with the potential risks when deciding to use the drug in patients with cardiovascular disease. In a review of a randomized, double-blind, placebo-controlled study of 700 patients treated with varenicline for smoking cessation, there was an increased risk of nonfatal MI, revascularization, angina pectoris, and peripheral vascular disease when compared with patients treated with placebo. Although the study was not designed to detect a statistical differenc...

 FDA Restricts Use of Simvastatin 80 mg Michael O'Riordan  The Food and Drug Administration is recommending that physicians restrict prescribing high-dose simvastatin (Zocor, Merck) to patients, given an increased risk of muscle damage [1]. The new FDA drug safety communication, issued today, states that physicians should limit using the 80-mg dose unless the patient has already been taking the drug for 12 months and there is no evidence of myopathy. "Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug," the agency states. In addition, the FDA is requesting that additional changes be made to the drug's label. The label will be changed to include the new dosing recommendations, as well as warnings not to use the drug with various medications, including itraconazole (Sporanox, Jannsen Pharmaceutica), ketoconazole (Nizoral by Ortho-McNeil Pharmaceutical), posaconazole (Noxafil, Merck), ery...