The Directorate-General for Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health issued an alert on a batch of the drug GUAIFENESIN SYRUP TG SYRUP vial x 100ml, batch SL-429 on May 18, 2023, following review by the World Health Organization (WHO). contaminated, valid until 10/2023, from the manufacturer QP PHARMACHEM LTD, from Punjab (India) and its seller is TRILLIUM PHARMA, from Haryana (India). This product was detected in the Marshall Islands and the Federated States of Micronesia and reported to the WHO on April 6, 2023.
Guaifenesin is an expectorant used to relieve coughing and buildup of mucus in the bronchi. Analyzes carried out by the Australian Therapeutic Goods Agency on samples of GUAIFENESIN SYRUP TG SYRUP found unacceptable concentrations of the pollutants diethylene glycol and ethylene glycol. To date, neither the manufacturer nor the seller have made any representations to WHO regarding the safety and quality of these products.
Ethylene glycol and diethylene glycol are toxic to humans when consumed and can be fatal. Its toxicity is essentially caused by the action of its metabolites; Ethylene glycol is the glycolate and oxalate responsible for metabolic acidosis and kidney damage (calcium oxalate crystals); Likewise, diethylene glycol is converted to HEAA (ethoxyhydroxyacetic acid), a metabolite responsible for kidney and neurological damage.
The WHO has previously issued three alerts related to contaminated medicines in liquid formulation No. 6/2022No. 7/2022No. 1/2023.
The first symptoms are usually digestive and neurological (decreased consciousness); Hypoglycaemia can occur in children. Profound metabolic acidosis, renal failure (tubular necrosis and/or calcium oxalate crystal deposition) and, in some cases, hypocalcemia, pancreatitis, hypotension and shock later develop; Other neurological disorders that may occur include peripheral neuropathy and cranial nerve involvement (bilateral facial nerve palsy), encephalopathy, tetraplegia, coma, and death.
Available: https://www.digemid.minsa.gob.pe/webDigemid/alertasmodificaciones/2023/alerta-digemid-no-41-2023/
Havana, June 15, 2023