WHO Examines Possible Correlation Between Cough Syrup Deaths, Offers Advice to Parents

Exclusive: WHO investigating links between cough syrup deaths, considers advice for parents

The World Health Organization (WHO) is investigating whether there is a connection between manufacturers whose contaminated cough syrups it has linked to the deaths of more than 300 children in three countries. A person familiar with the matter told Reuters that the WHO is seeking more information about the specific raw materials used by six manufacturers in India and Indonesia to produce the medicines. The WHO has not named any suppliers.

The WHO is also considering whether to advise families globally to reassess the use of cough syrups for children in general while questions over the safety of some of these products are unresolved. WHO experts are evaluating the evidence for whether, or when, such products are medically necessary for children.

The deaths of children from acute kidney injury began in July 2022 in Gambia, followed by cases in Indonesia and Uzbekistan. The WHO has said the deaths are linked to over-the-counter cough syrups the children took for common illnesses and which contained a known toxin, either diethylene glycol or ethylene glycol.

To date, the WHO has identified six drugmakers in India and Indonesia who produced the syrups. These manufacturers have either declined to comment on the investigation or denied using contaminated materials that contributed to any deaths. Reuters has no evidence of wrongdoing by the companies the WHO has named.

The WHO has widened its investigation into potential diethylene glycol and ethylene glycol contamination in cough syrups to four additional countries: Cambodia, the Philippines, East Timor and Senegal. It has called on other governments and the global pharmaceutical industry to launch urgent checks to root out substandard medicines and improve regulation.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said its members “are already doing what the WHO is calling for”, in line with national and international guidelines. WHO’s acting director for access to medicines, Hanan Balkhy, said more children may be affected.

The WHO has already issued specific alerts for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. Maiden’s manufacturing plant has been shuttered, but it is now seeking to reopen after the Indian government said in December that its testing had found no problems with Maiden’s products. Marion’s office phone went unanswered on Tuesday.

The WHO, working with Indonesia’s drugs regulator, also issued an alert in October about cough syrups made by four Indonesian manufacturers. PT Yarindo Farmatama, PT Konimex and PT AFI Farma did not immediately respond to requests for comment. PT Universal Pharmaceutical Industries’ lawyer said it had pulled from the market all cough syrups deemed dangerous.

The WHO said the syrups were contaminated with diethylene glycol and ethylene glycol, which it called “toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts.” Their toxic effects include an inability to pass urine, kidney injury and death.

The deaths have highlighted potential gaps in global regulation of commonly-used medications, including oversight of factories and supply chains. The WHO sets guidelines on medicine manufacturing standards globally and supports countries investigating any lapses, but it has no legal mandate or enforcement authority to take direct action against violators.