News
Is the drug Champix linked to being the cause of suicide?
It is a most tragic event where a person has taken their own life in unknown circumstances. At the outset, the sympathy of this Law Firm goes to the family and friends of deceased persons who have committed suicide.
Scientific and Legal Perspective
There has been much comment from both the scientific and legal perspective, as to whether Champix is associated with such tragic type events. Unfortunately, the detail required to substantiate a link between such events and the drug is still very much in its developmental phase.
Yet, it should be noted that the US Food and Drug Administration (FDA) issued a warning to healthcare professionals alerting them to "reports of suicidal thoughts and aggressive and erratic behaviour in patients who have taken Chantix" (otherwise Champix). Also other side effects such as euphoria, changes in dreaming, depression, nausea and emotional disorder are known to occur. The euphoria aspect is the most worrying as it can change a person's perception of risk.
Irish Medicines Board
In Ireland, the Irish Medicines Board, who regulate clinical trials, monitor and inspect products on the market in order to ensure their safety and efficacy are closely monitoring the situation by indicating that review is occurring at EU level. In addition, the IMB, with the European Medicines Agency is closely monitoring the safety of the drug Champix.
In brief, the IMB review has concluded that smoking cessation, with or without treatment maybe associated with symptoms of anxiety and depression, including exacerbation of underlying psychiatric illness. As a result, the product information for Champix was updated to include additional warnings about the risk of depression associated with its use and as a symptom of nicotine withdrawal. It was recommended that patients should be advised accordingly. Also, Healthcare professionals were reminded to closely monitor patients during use, advising them to report any symptoms during use to their GP.
It should be emphasised that the IMB relies upon Medical Practitioners notifying them of adverse reactions, which is an unsatisfactory system for notification as many medical practitioners may not be aware of all symptomology.
Further Developments
In Canada, further warnings have issued concerning Champix's potential side effects.
All of the foregoing are most worrying developments concerning the safety of this drug.
Yet, it is a matter to be determined by the appropriate regulatory authorities on an ongoing basis as to whether the risk of the drug versus the benefit of the drug merits its immediate suspension or withdrawal.
It is hoped that a precautionary approach will be adopted with all drugs when assessing their peculiar side effects or risks.
Managing Partner
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This news section contains stories of interest from publicly available news sources. Where we are representing the clients referred to in the news material we will say so. Where we do not represent individuals or bodies mentioned or quoted, the inclusion of the news story in our news section is not intended nor should it be taken to imply that we act for the individual or body concerned.
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