Contaminated cough syrups, the WHO alert and fears in Europe: “Serious risks for children”

The World Health Organization (WHO) has issued a alert on two cough syrups contaminated with toxic substances who would be responsible for death of about twenty children in Uzbekistan
. According to WHO, syrups, Ambronol And Dok-1 Max, produced by the Indian company Marion Biotech are of inferior quality and the company has not provided any guarantees of safety or quality. The Indian health ministry has suspended the production of the pharmaceutical company on which a criminal investigation has been opened while Uzbekistan has banned the importation of the drugs by withdrawing them from all pharmacies in the country.

toxic substances

Investigations conducted on samples of the product in Uzbek laboratories showed that both syrups contained unacceptable amounts of diethylene glycol and/or ethylene glycol, toxic substances for humans which, if consumed, can prove fatal. The products referred to in this warning are not safe and their use, especially in children, can lead to serious injury or death, warns WHO Europe. Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic colorless and viscous liquids which have a s
sweet taste. Although toxic, diethylene glycol is illegally used as a counterfeit glycerin in some countries and sold as cough syrup and toothpaste. According to the Centers for Disease Control, DEG and EG are sometimes found as contaminants in glycerin, which is used as sweetener in the formulations of many syrups orally ingested drugs.

Symptoms

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to urinate, headache, altered mental status and acute kidney injury which can lead to death, reads the alert. To date, the manufacturer has not provided assurances to WHO on the safety and quality of these products, WHO Europe said in the release.

The risk of informal markets

The two syrups may also have marketing authorizations in other countries of the European region, for this reason the WHO invites them not to be used. To alarm that the drugs dangerous to health could also have been distributed through informal marketsin other countries or regions emphasizes the World Health Organization.

Aifa: No risk in Italy

In this regard Aifa (the National Medicines Agency) reassures: in a note sent to Health Courier specifies that the syrups are not authorized in Italy and neither do they appear to have been introduced through the illegal market: From the information received from the technical offices, it appears that the syrups in question they are not authorized in Italy and therefore they cannot be infiltrated into the legal distribution network. There is no evidence of the presence of these products in the area (…) reported by WHO: the controls to which our network subjected, thanks to the traceability system of the Ministry of Health / IPZS active for almost twenty years and to the systematic work that AIFA and NAS share in this area, allow us to confirm that there are no risks for our country.

Pharmacosurveillance

WHO calls for increased surveillance and due diligence within the supply chains of countries and regions that may be affected by these products. Increased surveillance of the informal/unregulated market is also recommended. And the call to national regulatory and health authorities to inform WHO immediately if the products in question are discovered in the respective country. Finally, a message is addressed to citizens: If someone has used the syrups, developing reactions or experiencing adverse events after use, consult a doctor immediately and report the incident to the national regulatory authority or the National Pharmacovigilance Center.

The previous

Marion Biontech is the second Indian drugmaker to be investigated by regulators since a link emerged last October between the deaths of dozens of children in The Gambia with the consumption of other drugs. Maiden Pharmaceuticals has been accused of manufacturing several cough and cold medicines that are believed to have led to the deaths of at least 66 children in the African country. The victims, mostly between the ages of five months and four years, died of acute kidney failure.