Adverse Events in Medical Management -- Vigabatrin as a Paradigm of Forensic Responsibility With Novel Therapy
Medicine and Law 2001; 20(3): 329-335
The ethics of medical management are not always straightforward. There are many contributing factors: the condition treated; its effects on the patient; the required treatment; the effects of that treatment; and a cost/benefit ratio. Treatment of epilepsy with vigabatrin (VGB) exemplifies these problems. VGB has recently been reported to cause constricted visual fields. Formal testing of visual fields of patients attending an outpatient epilepsy service showed constriction with tunnel vision, even in patients who are asymptomatic. The ethical questions include: Should all reports of adverse events be subjected to tests of validity and subsequent quality assurance? Should treatment with VGB be stopped, risking recurrence of seizures? What are the legal consequences of continuing VGB? Does informed consent protect the doctor? After stopping VGB can the patient drive?
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Beran, Roy G. (2001)Doctors should advise patients of recognised adverse events of proposed therapy. It remains unclear what responsibility attaches to suspected potential for adverse events if these have not been reported. Vigabatrin (VGB) ...
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