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 a link between manufacturers of contaminated cough syrups linked to the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters. .

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

The WHO is also considering whether to advise families around the world to reassess the use of cough syrups for children while questions about the safety of some of these products remain unresolved, he said. WHO experts are evaluating the evidence to determine whether the product is medically necessary for children, he said.

Child deaths from acute kidney injury began in July 2022 in The Gambia, followed by Indonesia and Uzbekistan. The World Health Organization said the child deaths were linked to cough syrups taken by children for common illnesses and containing the known toxins either diethylene glycol or ethylene glycol.

To date, the WHO has identified 6 drug manufacturers in India and Indonesia that produce syrups. These manufacturers 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 listed by the WHO.

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“It is our highest priority to see no more preventable child deaths,” WHO spokeswoman Margaret Harris said without elaborating on the details of the organization’s work.

The United Nations health agency said Monday it had expanded its investigation into possible contamination of diethylene glycol and ethylene glycol in cough syrups to four other countries where the same products were sold: Cambodia, the Philippines, East Timor and Senegal. It has called on other governments and the global pharmaceutical industry to launch urgent inspections to stamp 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 requires” under national and international guidelines.

At a press conference on Tuesday, the World Health Organization’s acting director for access to medicines, Hanan Balkhi, said that more children may be affected by the disease.

“There are children out there who have been exposed to these drugs that we don’t even know about,” he told reporters, adding that this is why transparency throughout the supply chain is needed to address the issue.

The WHO has already issued specific warnings about cough syrups from two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. It said their juices were linked to deaths in Gambia and Uzbekistan, respectively, and warned people to stop using them.

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

Maiden has repeatedly told Reuters, including in December, that it has done nothing wrong, and Chief Executive Naresh Kumar Goyal said on Tuesday that he had no comment on the WHO, which is investigating possible links between the companies.

A phone call at Marion’s office 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, located near New Delhi, that it was being blamed for Uzbekistan’s death “for defaming India and the company”.

The WHO, which works 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, which is investigating the link between the deaths in the three countries.

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PT Universal Pharmaceutical Industries’ lawyer Hermansya Hutagalung said it has withdrawn all dangerous cough syrups from the market. “Prosecute the suppliers, they are the real criminals,” Hutagalung added. “They are the ones who made the raw ingredients by falsifying the raw ingredient documents all the way to the pharmaceutical companies.” He did not identify specific suppliers or provide details to back up the claim.

WHO said the juices were contaminated with diethylene glycol and ethylene glycol, which are “toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even in small amounts.” The effects of their toxicity 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 that manufacture products, for developing countries that lack the resources to monitor drugs for safety.

The WHO sets guidelines for drug manufacturing standards worldwide and supports countries investigating any errors, but it has no legal authority or authority to take direct action against violators.

Additional reporting by Prak Chan Thul in Phnom Penh, Stanley Vidianto and Ananda Terezia 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: The Thomson Reuters Trust Principles.

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