October 10, 2022: The WHO has issued a medical product alert for four medicines made by an India-based drugmaker, Maiden Pharmaceuticals, identified as “substandard” because they failed to meet quality standards.
Maiden’s products —- Promethazine Oral Solution, Kofexmalin Baby Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup —- have not provided guarantees to the WHO on the safety and quality of these products to date, according to a statement.
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
To date, these four products have been sold in the Gambia but may have been distributed through informal markets to other countries or regions.
“WHO has today (October 5) issued a medical product alert for four contaminated medicines identified in the Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children,” Director General of WHO, Tedros Adhanom Ghebreyesus said.
Toxic to humans
The WHO stated that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.
All batches of these products are unsafe until the relevant National Regulatory Authorities can analyze them.
The substandard products referenced in this alert are unsafe, and their use, especially in children, may result in severe injury or death.
Increased surveillance and diligence are required in the supply chains of countries likely to be affected by these products.
If you have used the product and suffered from an adverse reaction, you should seek immediate medical advice. You must report the incident to the National Regulatory Authority or National Pharmacovigilance Centre, according to the statement.
Further probe
The WHO is further investigating the company and holding talks with Indian regulatory authorities.
After being found in the Gambia, other countries may have distributed Maiden Pharma’s products.
“WHO recommended that all countries detect and remove these products from circulation to prevent further harm to patients.”
Maiden Pharma’s director, Vivek Goyal said the company was “shocked to hear the media reports regarding the deaths and deeply saddened on this incident,” Maiden.
Maiden Pharma has been obtaining raw materials for its medicines “from certified and reputed companies,” he said.
Government agencies visited the company’s factory four times between October 1 and 7, and the Central Drugs Standard Control Organisation(CDSCO) collected samples of the medicines for examination, according to. a company statement.
“The samples have been drawn by the CDSCO officials and we are awaiting the results and since the matter is already pending investigation and sub-judice, we cannot comment on any other issues,” he said.
