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

Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether there is any link between manufacturers whose tainted cough syrups it has linked to the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters.

Citing “unacceptable levels” of toxins in the products, the WHO is seeking more information on the specific raw materials used by six manufacturers in India and Indonesia to make drugs linked to the recent deaths, and whether the companies obtained them from any of the same suppliers, the person said. WHO has not named suppliers.

The WHO is also considering whether to advise families worldwide to reevaluate the use of cough syrups in general until questions about the safety of some of these products are resolved, the person said. WHO experts are evaluating the evidence on whether and when such products are medically necessary for children, the person said.

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

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

“This is of the highest priority for us, not to see any more child deaths from something that is so preventable,” WHO spokeswoman Margaret Harris said, without commenting further on the organization’s work.

The U.N. health agency said Monday it has expanded its investigation into potential contamination with diethylene glycol and ethylene glycol in cough syrups to four additional countries where the same products may have been on sale: Cambodia, the Philippines, East Timor and Senegal. Call me other governments and the global pharmaceutical industry to launch urgent reviews to root out substandard drugs and improve regulation.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in an emailed statement on Tuesday that its members are “already doing what the WHO calls for” in line with national and international guidelines.

At a press conference on Tuesday, the WHO’s acting director for access to medicines, Hanan Balki, said more children could be affected.

“There may be children exposed to these drugs that we’re not even aware of,” she told reporters, adding that this is why transparency is needed from everyone in the supply chain to solve the problem.

The WHO has already issued specific alerts for cough syrups produced by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. It says their syrups have been linked to deaths in The Gambia and Uzbekistan respectively, and the alerts urge people to stop using them.

The Maiden and Marion manufacturing plants are closed. Maiden is now seeking to reopen after the Indian government said in December that its tests had found no problems with Maiden’s products.

Maiden repeatedly told Reuters, including in Decemberthat it had done nothing wrong, and managing director Naresh Kumar Goyal said on Tuesday he had no comment on the WHO’s investigation into possible links between the controlled companies.

Marion’s office phone went unanswered Tuesday, and the company did not immediately respond to an email seeking comment. Earlier this month, it told the government of Uttar Pradesh, where it is located near New Delhi, that it was being blamed for the deaths in Uzbekistan “to tarnish the image of India and the company”.

The WHO, working with Indonesia’s drug regulator, also issued a warning in October about cough syrups made by four Indonesian manufacturers and sold domestically. The manufacturers are: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex, PT AFI Farma.

PT Yarindo Farmatama, PT Konimex and PT AFI Farma did not immediately respond to requests for comment on Tuesday about the WHO investigation into the links between the deaths in the three countries.

PT Universal Pharmaceutical Industries’ lawyer, Hermansyah Hutagalung, said they have withdrawn all cough syrups deemed unsafe. “Go after the vendors, they are the real criminals,” Hutagalung added. “They are the ones who are adulterating the raw materials by falsifying documents about the raw materials all the way to the pharmaceutical companies.” He did not name specific suppliers or provide details to support the claim.

The WHO said the syrups were contaminated with diethylene glycol and ethylene glycol, which it called “toxic chemicals used as industrial solvents and antifreezes that can be fatal even if ingested in small amounts.” Their toxic effects include inability to urinate, kidney damage, and death.

The deaths highlighted potential gaps in global regulation of commonly used drugs, including oversight of factories and supply chains, particularly those producing products for developing countries that lack the resources to monitor drug safety.

The WHO sets guidelines on drug manufacturing standards worldwide and supports countries investigating any lapses, but it has no legal mandate or enforcement powers to take direct action against violators.

Additional reporting by Prak Chan Thul in Phnom Penh, Stanley Vidianto and Ananda Teresa in Jakarta, Krishna N. Das in New Delhi, Saurabh Sharma in Lucknow, Ed McAllister in Dakar; Edited by Sarah Ledwith, Michelle Gershberg, Claudia Parsons, William McLean

Our standards: Thomson Reuters Trust Principles.

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