Pharmacovigilance and Tuberculosis: Applying the Lessons of Thioacetazone
(2014; 2 pages)


Following its introduction in the late 1940s, thioacetazone was widely-used as an anti-tuberculosis medicine in the following decades. Reports of cutaneous hypersensitivity reactions related to its use emerged in the literature soon after its introduction and by the early 1970s the association between the medicine and the adverse drug reaction was well established. Despite the increased recognition of this risk, thioacetazone remained in use mainly in low-income countries because of its low cost.

In the late 1980s and early 1990s, reports appeared from Africa describing an increased risk of severe cutaneous reactions associated with the use of thioacetazone in persons with human immunodeficiency virus (HIV) infection...For more than 50 years, WHO has been encouraging countries to reinforce their pharmacovigilance – the surveillance of adverse drug reactions – at national level...

Currently the WHO Programme for International Drug Monitoring – a worldwide pharmacovigilance network – receives individual case safety reports from the national drug safety authorities of 118 countries. Spontaneous reports of adverse drug reactions, submitted by participating countries are gathered in the database VigiBase™, which is maintained by the WHO Collaborating Centre, the Uppsala Monitoring Centre in Sweden.9 VigiBase™ has accumulated well over nine million individual case safety reports since the late 1960s, over half of which have been received in the last five years.

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