The World Health Organization (WHO) defines pharmacovigilance as “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” (WHO 2000). As a result, a wide range of healthcare professionals, including doctors, nurses, and pharmacists can contribute to pharmacovigilance activities. Such activities are a critical aspect of medical practice and have the potential to reduce and possibly prevent drug-related harm and associated costs.

Pharmacovigilance is of particular importance in the field of psychiatry (Rajkumar and Melvin 2014). Most psychiatric disorders are primarily treated with drugs, all of which are associated with their own adverse drug reactions (ADRs). Soon after the advent of modern psychopharmacology in the early 1950s, it became clear that the use of first available psychotropic drugs was sometimes associated with life-threatening or disabling adverse effects. This is the case with neuroleptic malignant syndrome and tardive dyskinesia associated with traditional antipsychotics or the potentially fatal hypertensive crises occurring when irreversible monoamine oxidase inhibitors, the first clinically effective antidepressants, are given in combination with tyramine-rich food.

The birth of pharmacovigilance is closely related to psychiatry. In the late 1950s, thalidomide was widely used in several countries as an antiemetic and a “safe sedative,” particularly effective when given to pregnant women. It was soon noticed by physicians that babies exposed to the drug in utero developed congenital malformations (McBride 1961). Widespread use of thalidomide in Europe, Australia, and Japan resulted in approximately 10,000 children born with phocomelia, leading to the ban of thalidomide in most countries. The thalidomide tragedy is generally regarded as the beginning of legislated pharmacovigilance (Moore 2013). This disaster marked a turning point in toxicity testing, as it prompted international regulatory agencies to develop systematic toxicity testing protocols. From such a tragedy, national pharmacovigilance centers emerged, as well as the development of spontaneous reporting to identify ADRs that could justify or mandate regulatory action.

Over the years that followed, pharmacovigilance activity has led to the identification of several adverse drug reactions caused by psychotropic drugs, resulting in their withdrawal from the market or restrictions in use. In 1973, a number of fatal cases of agranulocytosis cases occurred with clozapine treatment which led to the withdrawal of this efficacious antipsychotic drug in some countries and to restriction of use in many others (McKenna and Bailey 1993). Zimelidine was the first selective serotonin reuptake inhibitor (SSRI) antidepressant to be marketed in the early 1980s. Within a year and a half of its introduction, rare case reports of Guillain-Barré syndrome emerged that appeared to be caused by the drug, prompting its manufacturer to remove it from the market (Fagius et al. 1985). The antidepressant nomifensine, a noradrenaline and dopamine reuptake inhibitor, was withdrawn worldwide by the manufacturer in January 1986 following a rising incidence of reports of acute immune hemolytic anemia with serious clinical sequelae, including a number of fatalities (Stonier 1992). The clinical use of the atypical antipsychotic remoxipride was severely restricted in 1993, soon after its marketing, due to reports of aplastic anemia (Nadal 2001). In 1994, alpidem, an anxiolytic drug from the imidazopyridine family, was withdrawn from the market following reports of severe liver damage (Berson et al. 2001). The atypical tricyclic antidepressant (TCA) amineptine, a selective inhibitor of the reuptake of dopamine and, to a lesser extent, noradrenaline, was marketed in some European countries as an antidepressant and soon gained a reputation for abuse potential due to its short-lived, but pleasant, stimulant effect experienced by some patients. The emergence of severe cases of hepatotoxicity, along with the potential for abuse, led to the suspension of marketing authorization in 1999 (Lazaros et al 1996, No authors listed 1999). More recently, there were concerns on the propensity of some antipsychotics to prolong corrected QT (QTc) interval and to cause severe cardiac arrhythmias including torsades de pointes and sudden death. This led to the withdrawal of some antipsychotics from the market (e.g., thioridazine), temporary suspension (e.g., sertindole), or restriction of use (e.g., pimozide) (Glassman 2005).