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
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2 nd Annual Essentials in Primary Care<br />
Fall Conference<br />
Friday, November 11, <strong>2011</strong><br />
Liraglutide – Victoza<br />
Risk of Thyroid C-cell Tumors BLACK BOX WARNING<br />
• Liraglutide causes dose-dependent and treatmentduration-dependent<br />
thyroid C-cell tumors<br />
(adenomas and/or carcinomas) at clinically relevant<br />
exposures in both genders of rats and mice.<br />
• In the clinical trials, there have been 4 reported cases<br />
of thyroid C-cell hyperplasia among Victoza-treated<br />
patients and 1 case in a comparator-treated patient<br />
(1.3 vs. 0.6 cases per 1000 patient-years).<br />
– a 5 year epidemiological study using a large healthcare<br />
claims database to compare the development of thyroid<br />
cancer among patients with T2DM who use Victoza to<br />
those who are not using this medicine.<br />
– develop a medullary thyroid cancer registry to monitor<br />
how many cases of medullary thyroid cancer occur each<br />
year for at least 15 years<br />
Liraglutide – Victoza<br />
• It is unknown whether Victoza will cause<br />
thyroid C-cell tumors, including medullary<br />
thyroid carcinoma (MTC), in humans<br />
• Counsel patients regarding the risk for MTC<br />
and the symptoms of thyroid tumors (e.g. a<br />
mass in the neck, dysphagia, dyspnea or<br />
persistent hoarseness).<br />
Wayne Weart<br />
<strong>New</strong> <strong>Drug</strong> <strong>Update</strong> Part I
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