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

Exclusive: WHO investigating links between cough syrup deaths, assesses advice for parents
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Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether there is a link between contaminated cough syrups and the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters.

Referring to “unacceptable levels” of toxins in products, WHO is seeking more information on the specific raw materials six manufacturers in India and Indonesia use to manufacture the drugs linked to the recent deaths, as well as whether companies source them from some. same suppliers, said the person. WHO did not specify any suppliers.

The person in question said WHO is also considering whether to advise families around the world to reconsider the use of cough syrups for children in general, while questions about the safety of some of these products have yet to be resolved. The person said WHO experts are evaluating the evidence as to whether or when such products are medically necessary for children.

Children’s deaths from acute kidney injury began in Gambia in July 2022, followed by cases in Indonesia and Uzbekistan. The WHO said the deaths were linked to over-the-counter cough syrups that children use for common illnesses and that contain a known toxin such as diethylene glycol or ethylene glycol.

To date, WHO has identified six pharmaceutical manufacturers producing the syrups in India and Indonesia. These manufacturers have either refused to comment on the investigation or have refused to use contaminated materials that contributed to any deaths. Reuters has no evidence of misconduct by companies named by the WHO.

“It’s our top priority not to see more child deaths than something preventable,” said WHO spokesperson Margaret Harris, without further commenting on the details of the organization’s work.

The United Nations health agency said Monday it is expanding its investigation into potential diethylene glycol and ethylene glycol contamination in cough syrups to four more countries where the same products may be on sale: Cambodia, Philippines, East Timor and Senegal. called to other governments and the global pharmaceutical industry to initiate urgent controls to eradicate substandard drugs and improve legislation.

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

WHO is expected to comment further on the cough syrup situation at a press conference late Tuesday.

WHO has already issued specific warnings for cough syrups produced by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. He said his syrups have been linked to deaths in The Gambia and Uzbekistan, respectively, and warnings are asking people to stop using them.

Maiden and Marion’s production facilities were closed. Maiden is now looking for ways to reopen after the Indian government announced in December that there were no problems with Maiden’s products in its tests.

Maiden repeatedly told Reuters: in Decemberthere is nothing wrong with that, and Director-General Naresh Kumar Goyal said on Tuesday that he did not comment on WHO’s investigation of possible links between the companies studied.

Marion’s office phone went unanswered Tuesday, and the company didn’t immediately respond to an email seeking comment. Earlier this month, he told the government of Uttar Pradesh, near New Delhi, that he had been accused of “smearing the image of India and the company” over the deaths in Uzbekistan.

WHO, working with Indonesia’s drug regulator, also issued a warning in October about cough syrups produced and sold domestically by four Indonesian manufacturers. 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 requests for comment Tuesday on WHO’s investigation of links between deaths in the three countries.

Hermansyah Hutagalung, attorney for PT Universal Pharmaceutical Industries, said it has pulled all cough syrups considered dangerous from the market. “Chase the suppliers, they are the real culprits,” Hutagalung added. “They are those who imitate raw materials by falsifying raw material documents up to pharmaceutical companies.” It did not identify specific suppliers or provide details to support the claim.

WHO said the syrups were contaminated with diethylene glycol and ethylene glycol, calling them “toxic chemicals used as industrial solvents and antifreeze agents that can be deadly, even in small quantities.” Toxic effects include urinary incontinence, kidney damage and death.

The deaths highlighted potential gaps in global regulation of commonly used drugs, including surveillance of factories and supply chains, particularly those that manufacture products for developing countries that do not have the resources to monitor drugs for safety.

WHO sets guidelines for pharmaceutical manufacturing standards globally and supports countries investigating any defect, but has no legal or enforcement authority to take direct action against violators.

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

Our standards: Thomson Reuters Trust Principles.

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