Chunk #29 — 3. Results — 3.4 Association of Suicide and the Use of Smoking Cessation Medications — 3.4.2. Epidemiological/Clinical Data — 3.4.2.2. Nicotine partial agonists
A non-peer reviewed study listed 227 reports of “suicide/self-injury” including 28 cases of completed suicide to the US FDA over a 20 month period (The Institute for Safe medication Practices 2008). The US FDA released warnings for varenicline, citing 491 cases of suicidal ideation, attempts or completed suicides (US Food and Drug Administration 2008) Many of these occurred while using varenicline and continued smoking, suggesting they cannot be attributed to nicotine withdrawal. The US Veterans Association released a similar report citing 32 instances of suicide among 147,718 prescriptions (0.02%) (Department of Veterans Affairs 2008). None of these reports provide more detail and neither concluded causality had been established; however, both believed these data indicate further investigation is needed. Neither report estimated the incidence of suicide in medication users. If one assumes reports of AEs are typically only 1% of the actual rates(The Institute for Safe medication Practices 2008) and that over 5.5 million smokers in the US have used varenicline; then the incidence of all suicidal outcomes is probably less than 1% and the rate of completed suicides is even less.
