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Champix (varenicline): Submission of a written request about the safety measures of the smoking cessation drug Champix.


Champix is widely used in Japan as an aid to smoking cessation treatment.

However, a significant number of neuropsychiatric symptoms have been observed, including changes in behavior, agitation, depressed mood, suicidal thoughts and suicidal behavior.

Nevertheless, these harmful events are not written in the warning section of Japanese Prescription Information. On the otherhand,the information wrongfully suggests that these symptoms may have resulted from the smoking cessation itself.

On July 6th 2009 we submitted a written request to the Ministry of Health, Labour and Welfare (MHLW) and Pfizer (Japan) about the safety measures of the smoking cessation drug Champix.

< Our Request Outline >

1. To revise the package insert as below:
(1) Include in the "warning" section reports of adverse effects, such as depressed moods, anxiety, irritation, agitation, change in behaviour, suicidal thoughts and suicide.
(2) Clearly state that these symptoms are being reported among patients who continue to smoke while taking Champix. Revise the attached document's information which states that the symptoms occurred as a result of not smoking.
(3) Instruct patients not to do anything that could be dangerous, such as driving or operating machinery.
(4) The prescription of Champix should be limited to situations in which nicotine replacement therapy is intolerable for the patient.

2. To make a comprehensive effort to improve methods of assessing and monitoring the risks associated with drugs and biological products as per the US Food and Drug Administration (FDA).

3. To implement pharmacoepidemiological research immediately to clarify the causal relationship between Champix and psychoneurotic disorders, focusing on chronological sequence and dosage.

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