The MATTERS OF CONCERN are as follows:
(brief summary of matters of concern)
 
The circumstances in which Sean came by his death, the combined effects of clozapine with alcohol, seems to be, statistically, very rare. None of the professionals who gave evidence in this case could cite a death with the same cause of death as that suffered by Sean. This said, clozapine is a well-established medication whose side effects are well known. It was originally developed in the 1950’s.  It is well-known that it requires careful management and monitoring. The side effects are recognised ones and widely known. None of the professional witnesses expressed any lack of familiarity with it or its side effects. One of these side effects is sedation. Likewise, obviously, alcohol is a recognised central nervous system depressant. This is a death from Central Nervous System Depression, consequent to a comparatively high level of clozapine and a comparatively high level of ethanol in the blood – neither individually fatal. It is evident that there is no guidance in any academic literature, British National Formulary, or NICE or MHRA advices on the dangers of death in this scenario. It is noticeable that the leaflet that comes with the Clozaril (clozapine) packages clearly states that it must not be taken with alcohol, and the evidence to me was that the medication comes with a further label, in a similar vein, on the packaging. Neither, however, advises of death being a possibility. All the literature advises that sedation is a potentially dangerous side effect of clozapine. Death from Central Nervous System Depression, over-sedation, is not uncommon. It is often associated with alcohol, and other substance, use.

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