Off Label Use of Antidepressants: Pro's and Con's

Abstract

Off label use of psychopharmacy is in widespread use. Some psychiatric disorders are more treated off label – this was for long time the case for bipolar disorder and probably still is – than in label.

What is off label medication? All medications without a proper licence by the respective drug authority? That means also medications which have a licence in another country/region off label, if not licenced in the respective country? That includes also medications which demonstrated evidence based efficacy and which are suggested in guidelines, but (so far) no licenced? The term regulates in a very strict way the use of certain compounds, while refusing others which are believed to belong to the state of art or even to be innovative.

The pros and cons of off label medication are described using the off label use of antidepressants as example. The antidepressants – in the beginning the tricyclics and later on novel antidepressants with anti-histminergic profile – started to be widely used off label, after the ban of the benzodiazepines, for the treatment of nervousness, anxiety, sleep problems (for long-time especially amitryptiline, doxepine, mianserine, mirtazapine, trimipamine). With the upcoming interest in bipolar depression the discussion started, whether the use of antidepressants is off label in this indication or supported by the general indication major depression. The use of antidepressant in personality disorders is off label, but has a long clinical tradition, although the cost – benefit – relation is unclear (induction of outbursts, induction of suicidality). The use of some special antidepressant (tricyclics especially amitryptiline, novel dual antidepressants) as adjunctive to pain therapy is partially in label, partially off label.