Essential medicines and health products

A practical handbook on the pharmacovigilance of medicines used in the treatment of tuberculosis


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Publication details

Number of pages: 124
Publication date: May 2012
Languages: English, French and Russian
ISBN: 978 92 4 150349 5


Why pharmacovigilance for anti-TB medicines?

Most of the medicines used to treat tuberculosis (TB) today have been on the market for several decades. Clinicians treating TB patients around the world know these medicines well, and are usually well aware of their associated adverse drug reactions (ADRs). The occurrence of these reactions is known to be frequent. The TB patient on treatment is taking more than one anti-TB medicine simultaneously and regimens last from many months to 2 years or more.

This increases the likelihood of ADRs, some of which are severe. Most patients on treatment for drug-resistant TB experience at least one side-effect, and a recent study has shown that two thirds of such patients have had at least one medicine stopped temporarily or permanently as a result of ADRs.1 These events may damage public confidence in any national treatment programme and affect patient adherence. Patients who stop taking anti-TB medicines pose a risk to themselves and to others. The generation of drug resistance is a very real risk...