(1999; 168 pages) [Spanish]
12. Pharmaceuticals contaminated with diethylene glycol
The Committee discussed the cumulative incidence of diethylene glycol poisoning over the past 60 years, which has resulted in over 500 deaths of patients worldwide where glycerol contaminated deliberately or accidentally with diethylene glycol, or diethylene glycol alone, had been used in manufacturing pharmaceutical products. This continuing problem underlined the importance of ensuring quality and safety in the manufacture of medicinal products. The Committee agreed that there is no valid substitute for vigorous implementation of GMP in the production of pharmaceuticals. It proposed, however, that international measures such as special labelling and/or other identification methods for diethylene glycol should be considered, to avoid its use in the manufacture of pharmaceutical products. Moreover, the Committee recommended that WHO take active leadership in identifying ways of preventing further deaths from this cause.