Off Label Use of Other CNS Drugs (e.g.psychostimulants, Anticonvulsants, Lithium): Pro's and Con's

Abstract

Whether a drug is available in a particular country is based on a political decision motivated by scientific and other arguments. Some authorities may decide that available evidence regarding clinical efficacy, safety and tolerance of a certain drug is insufficient, and manufacturers may consider that the market in a particular country is too small for the introduction of a drug. On the other hand, on an international level, guidelines for the treatment of psychiatric disorders are established by authors, authorities in the field of pharmacotherapy. The recommendations are based on the evaluation of studies but also on the opinions of experts. According to the categories of evidence (A – F), recommendation grades (1 – 5) are defined, and therefore, this has also to be considered at least partly as a subjective approach. Moreover, the off-label use of drugs comprises the 4 ‘D”: diagnosis, drugs, doses, duration (of treatment) (cf Baldwin, Kosky, Adv. Psychiat. Treatment 13 (2007) 414). In particular, psychostimulants, anticonvulsants, lithium and thyroid hormones are widely prescribed in off-label conditions, e.g., psychostimulants are used as add-on medications in treatment resistant depression, lithium in psychiatric disorders presenting a chronobiological component (e.g. some forms of alcoholism), some anticonvulsants such as topiramate are considered to be helpful for the treatment of alcoholism or weight problems. Moreover, almost all neuropsychiatric agents are prescribed for personality disorders, but almost none of them is officially introduced for this indication. Finally, the baclofen – alcoholism story illustrates the conflicts existing in the field of off label prescriptions.