The list of adverse effects linked to varenicline (prescribed to help smokers quit) is growing longer.
In December 2007, 1,241 adverse effects were reported to the UK drug regulatory body. As well as gastrointestinal disorders, neuropsychiatric disorders are even more striking since they had already been identified as a risk during clinical trials. The main effects are headaches (125 cases), altered dreams (72) and nightmares (35), insomnia (63), depression (86) and depressive mood (33), suicidal thoughts (36).
Furthermore, varenicline is suspected of carrying a risk of myocardial infarction and cardiac arrhythmia. The UK regulatory body reports 31 cases of chest pains and 51 cases of malaise.
In the first 6 months after its commercialisation, the French drug regulatory body (AFSSAPS) received 335 reports of adverse effects associated with varenicline, especially gastrointestinal, psychiatric and cardiovascular disorders, with no further details.
In practice, when it seems appropriate to prescribe a drug treatment to help a person give up smoking, it is better to keep to nicotine.
©Prescrire April 2008
Source: "Varénicline : bilan britannique" Rev Prescrire 2008; 28 (294) 266.
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