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

The World Health Organization (WHO) is investigating whether there is a link between the manufacturers of the pertussis vaccine, which has been linked to the deaths of more than 300 children in three countries. According to those who know about this problem told Reuters.

Citing “unacceptable levels” of toxins in products, the World Health Organization is seeking more information on specific raw materials used by six manufacturers in India and Indonesia to produce drugs. Related to recent deaths, as well as whether those companies got them from some. Same supplier. The WHO did not name any suppliers.

The WHO is also considering whether to advise families around the world to re-evaluate the use of cough syrups for children in general, while questions about the safety of some of these products remain unresolved, he said. Experts say the World Health Organization (WHO) is evaluating evidence that such products are medically necessary for children.

Child mortality from acute kidney injury began in July 2022 in the Gambia, followed by cases in Indonesia and Uzbekistan. The WHO said the deaths were related to cough syrups used by children for common illnesses and contained toxins known as diethylene glycol or ethylene glycol.

To date, the World Health Organization has identified six drug manufacturers in India and Indonesia that produce syrups. The manufacturers declined to comment on the investigation or to use any contaminants that contributed to the deaths. Reuters has no evidence of misconduct by companies named by the World Health Organization.

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“This is a top priority for us to prevent the death of children from preventable causes,” said Margaret Harris, a spokeswoman for the World Health Organization.

The UN health agency said Monday that it has expanded its investigation into the potential for contamination of diethylene glycol and ethylene glycol in cough syrup to four more countries where the same product may be present. Available: Cambodia, Philippines, East Timor and Senegal. It called on other governments and the global pharmaceutical industry to launch urgent inspections to eliminate substandard drugs and improve regulations.

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

The World Health Organization is expected to comment further on the cough medicine situation during a press conference later Tuesday.

WHO has already issued specific notices for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October. 2022 and earlier this month. It said their syrup had been linked to deaths in the Gambia and Uzbekistan, respectively, and warned people to stop using it.

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Both Maiden and Marion manufacturing plants were closed. Maiden is now seeking re-launch after the Indian government said in December that its testing had no problems with Maiden products.

Maiden has repeatedly told Reuters, including in December, that there was nothing wrong with it, and managing director Naresh Kumar Goyal said on Tuesday that he had no comment on the World Health Organization’s possible investigation into the possible relationship. There are between companies under control.

Marion’s office phone did not respond Tuesday, and the company did not immediately respond to a request for comment. Earlier this month, it told the government of Uttar Pradesh, where it is located near New Delhi, that it had been blamed for deaths in Uzbekistan “for tarnishing the image of India and its companies”.

The WHO, which works with Indonesia’s drug regulators, also issued a notice in October about cough medicine produced by four Indonesian manufacturers and sold locally. Manufacturers: 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 Tuesday’s request for comment on the World Health Organization, which is investigating links between deaths in the three countries.

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Hermansyah Hutagalung, a lawyer for PT Universal Pharmaceutical Industries, said it had pulled out of the market all cough syrups considered dangerous. “Chasing suppliers, they are real criminals,” Hutagalung added. “They falsify raw ingredients by forging raw ingredients documents all the way to pharmaceutical companies.” He did not identify specific suppliers or provide details to back up the claim.

The WHO says the syrup is contaminated with diethylene glycol and ethylene glycol, so-called “toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even if ingested in small amounts.” Theirs includes inability to pass urine, kidney injury and death.

The deaths indicate potential gaps in the universal regulation of commonly used drugs, including factory and supply chain inspections, especially products for developing countries that lack the resources to control drugs for safety.

WHO sets guidelines for global drug standards and supports countries that investigate any delays, but has no legal mandate or law enforcement authority to take direct action against violators.

Additional reporting by Prak Chanthul in Phnom Penh, Stanley Widianto and Ananda Teresia in Jakarta, Krishna N. Das in New Delhi, Saurabh Sharma in Lucknow, Ed McAllister in Dakar; Edited by Sara Ledwith, Michele Gershberg and Claudia Parsons

Our Standards: Thomson Reuters Trust Principles.

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