Champix (in de VS Chantix) is een anti-depressivum dat veelvuldig voorgeschreven wordt bij het stoppen met roken. Een anti-depressiemiddel gebruiken bij geestelijk gezonde mensen is vragen om moeilijkheden. Complicaties die kunnen optreden zijn agressiviteit, depressiviteit duizeligheid en zelfs zelfmoord.
De Amerikaanse toezichthouder op geneesmiddelen, de FDA, heeft al vele bijwerkingen verzameld. Een volledig rapport rond dit middel is te vinden op de FDA website. In dit rapport staat onder andere:
Safety Concerns Identified Through Postmarket Experience
In adults, number of postmarket safety concerns have been identified and added to the label including neuropsychiatric adverse events, cardiovascular events, somnambulism, seizures and potential interaction with alcohol.
Expectations on Safety in the Postmarket Setting
If used in adolescents, it is expected that varenicline will have similar safety profile as in adults.
Integrated Assessment of Safety
Overall, the safety profile in adolescents is similar to adults. In placebo-controlled studies in adults, 12% of subjects on Chantix discontinued treatment due to adverse events compared to 10% in placebo group. In the adolescent efficacy study; discontinuation of treatment/study due to adverse event was 3% in high dose varenicline group compared to 1% in low dose varenicline and 3% in placebo group. Additionally, 3% in high dose varenicline group stopped the study medication and completed the study. The types and frequencies of common adverse events were also similar to those reported in adult studies. Overall, the safety profile in adolescents is similar to adults.
Conclusions and Recommendations
The effectiveness of Chantix is well established in adult smokers (18 years of age and older). The efficacy trial in this supplement did not demonstrate that varenicline is effective in adolescent smokers 12 to 16 years old. The study was not powered to assess the efficacy in 17 to 19 year old group. Considering that the side effect profile of varenicline including neuropsychiatric side effects is similar to adult population and the effectiveness is not demonstrated in smokers 12 to 16 years of age, the risks outweigh the benefits. As such, varenicline is not recommended in pediatric population 16 years of age and younger.