Varenicline
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Cardiovascular disorders: 27 case reports In a prospective study*, 27 patients were identified after they developed cardiovascular disorders while receiving varenicline for smoking cessation [routes not stated]. Four patients died. Nineteen men and eight women, aged 39–67 years [age not reported for one female patient], were receiving varenicline [some dosages not stated]. After 1–101 days of varenicline, 19 patients developed angina and/or myocardial infarction (MI), three patients had hypotension, one had ischaemic heart disease, one had ventricular tachycardia and one patient developed ventricular fibrillation leading to fatal heart arrest. Additionally, there was one case of sudden death, in which the postmortem analysis showed left ventricular hypertrophy and coronary artery disease, and one man developed circulatory collapse after 4 days of varenicline 0.5mg daily. One of the patients with hypotension had restarted varenicline 1mg daily 12 hours prior to the onset of symptoms; she had stopped the drug 3–4 days earlier [duration of treatment not stated]. Three patients had previously received varenicline with no adverse events. Varenicline was withdrawn for 10 patients, while another patient received a reduced dose of varenicline 0.5mg daily with improved symptoms. Six patients continued to receive varenicline, while seven patients had stopped varenicline 2–28 days prior to the onset of symptoms. Twenty patients fully recovered, with three of these requiring stent insertion. One patient recovered from angina; however, 2 months after stopping varenicline, he developed an MI [outcome not stated]. One man died within minutes of developing an MI, while another woman died 25 days after an MI from ovarian cancer. Author comment: "This case-series study . . . identified cases considered to have a causal relationship with varenicline." * The overall findings of this study have been previously summarised in Reactions News [see Reactions 1383 p5; 801159769]. Harrison-Woolrych M, et al. Cardiovascular events in patients taking varenicline: A case series from intensive postmarketing surveillance in New Zealand. Drug Safety 35: 33-43, No. 1, Jan 2012. Available from: URL: http:// 803066016 dx.doi.org/10.2165/11597690-000000000-00000 - New Zealand
0114-9954/10/1385-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved
Reactions 21 Jan 2012 No. 1385
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