Psychotropic agents, adverse

It would be useful for pharmaceutical physicians to have some examples of medical products that have been the subject of serious adverse reactions requiring regulatory action. In the following subsections a number of products have been selected that illustrate different drug safety problems. Major attention has been paid to psychotropic agents because they are widely used and have been the subject of regulatory evaluation and action over the past several years which has resulted in restrictions to use and in some cases withdrawal from the market. 

Of 14 consecutive patients with bipolar I disorder, who were inadequately responsive to standard psychotropic agents and who were given olanzapine, 8 improved (20). The most common adverse effects were sedation, tremor, dry mouth, and increased appetite with weight gain. 

In summary, these studies indicate that synthetic kavalactones and kava extract preparations alike are effective in managing anxiety disorders and anxiety symptomatology in a wide array of individuals. Kava was found to be as effective as the benzodiazepines but without their adverse effects. Further, the few adverse effects associated with kava were minor and transient in nature. However, the database on the clinical effects of kava by itself, and in comparison to and together with other psychotropic agents, is currently very small. This is an area ripe for further well-controlled, multi[Pg.149]

Other medications, which will not be discussed in the following chapters, have psychotropic actions that are considered to be side effects or adverse effects. Thus, some antihistamines (Le. products used to counteract allergic reactions) induce fatigue and drowsiness, and the same applies to some myorelaxants. Older antihypertensives (Le. agents reducing blood pressure) such as alpha-methyldopa (Aldomet ) or clonidine (Catapres 1) can cause fatigue and depression. 

Fortunately, for most psychotropics, side effects are minimal, usually involving nuisance complaints. With some agents, such as clozapine, however, the potential for more serious adverse effects does exist and must be carefully explained to the patient and family. Although managed care has successfully controlled overall financial costs, it is our responsibility to advocate for the optimal delivery of treatment, which necessarily takes into consideration not only the immediate expense of treatment but the impact of appropriate care in the long-term. As importantly, one should always factor in the cost of not providing adequate treatment, including ... 

I. lanku, Problems in the evaluation of the relative biological potency of chemical agents, in Adverse Effects of Environmental Chemicals and Psychotropic Drugs, VI, M. Horvat, ed., Elsevier, London, 1973. 

A condition known as absinthism was observed in chronic consumers of the alcoholic beverage absinthe, which contains wormwood extract. The condition was described as a form of alcoholism that included delirium, hallucinations, tremors, and seizures (Lee and Balick 2005). While the compound thujone was once thought to be the primary cause of the psychotropic activity and toxicity of absinthe, recent analyses of absinthe indicate that the thujone content of historical and contemporary samples is insignificant and that other ingredients, such as the coloring agents copper sulfate or antimony chloride, may have been responsible for the adverse effects of absinthe (Blaschek et al. 2002 Lachenmeier et al. 2008). 

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