The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported in several countries linked to contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG) in their formulations.
According to WHO’s health alert issued in January, reports of contaminated cough syrups containing DEG and EG were linked to 300 deaths in three countries last year, with most of the fatalities occurring in children. WHO’s alert said “these contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.” The international agency’s excipient GMP guide was last updated in 1999 in WHO’s Technical Report 51 Series No 885…
