The WHO issued a “medical product alert” on Wednesday for four cough and cold syrups suspected of being linked to “kidney damage” in children and responsible for 66 deaths.
Suspicious infant deaths. The World Health Organization (WHO) issued an alert on Wednesday about cough syrups produced by the Indian laboratory Maiden Pharmaceuticals. They are believed to be linked to the deaths of 66 children in The Gambia.
· What is the WHO alert about?
On Wednesday, WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced a “medical product alert” during a weekly news conference on global health issues.
It warns of the use of four cough and cold syrups suspected of causing “acute kidney damage and the death of 66 children” in The Gambia.
Four products are affected: promethazine oral solution, Kofexmalin infant cough syrup, Makoff infant cough syrup and Magrip N cold syrup, all made by the Indian company Maiden Pharmaceuticals Limited.
· When did the investigation begin?
An investigation was opened in mid-July into the recent death of 28 children from acute kidney failure, Gambian health authorities reported on September 9. These children were between 5 months and 4 years old.
Authorities then identified two possible causes of these deaths: paracetamol syrup, which hospitals and clinics were instructed not to use, and a possible infection with E. coli bacteria.
But on September 23, the Gambian authorities ordered that all medicines containing paracetamol or promethazine syrup be withdrawn.
· What possible link between the syrups and the 66 deaths?
The WHO said on Wednesday that the first tests have been carried out in the laboratory. They reveal “diethylene glycol and ethylene glycol contamination in unacceptable amounts” in each of the 4 syrups.
These two components are toxic and can cause many symptoms such as abdominal pain, vomiting, diarrhea, inability to urinate, headaches, or even altered mental status. In the most severe cases, acute kidney damage occurs that can lead to death.
· Where are the investigations?
The director of the WHO announced on Wednesday that he had informed the Indian medicines regulatory body at the end of September of these suspicious deaths. Investigations, still ongoing, were then launched with the Indian authorities and the WHO.
Tests are currently underway on other syrups, also potentially suspect, according to the Gambian Minister of Health. Results are expected soon, Reuters reports.
In the meantime, the WHO recommends that all countries detect and remove these drugs from circulation. The operation began on Wednesday and is proving difficult, with officers being sent door-to-door in rural areas.
In addition to individuals, all drug importers, wholesalers, retailers and all health establishments, of course, are also affected by this recall. Some products were still on sale recently in hospitals and private clinics, according to the Gambian Minister of Health.
· What are the Indian health authorities responding to?
Two Indian officials said they are awaiting further information from the WHO on this case and that in particular it shows a clear “causal link” between the incriminated syrups and the 66 Gambian deaths, Reuters said on Thursday.
Maiden Pharmaceuticals Ltd, as well as the Indian Medicines Regulatory Authority, did not respond to requests from the news agency.
· Could other countries be affected?
At the moment, the syrups in question have only been seen in The Gambia, but it is possible that they have been distributed in other countries informally, according to the WHO.
“Furthermore, the manufacturer could have used the same contaminated material in other products and distributed them locally or exported them. Therefore, a global risk is possible”, worries the health organization that recommends that all countries work to “detect and withdraw these products”.
The pharmaceutical company produces 2.2 million bottles of syrup a year that are sold in Asia, Africa and Latin America. The Indian authorities say, for their part, that the syrups in question were only exported to Gambia.
Original article published on BFMTV.com
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