As many as 96 people in Argentina are now believed to have died after being treated with medical-use fentanyl contaminated with bacteria.
The official death toll stands at 87, but judicial sources told the Buenos Aires Herald that a further nine deaths are under investigation.
Concerns were first raised in May, when dozens of hospital patients developed serious bacterial infections. Tests identified strains of Klebsiella pneumoniae and Ralstonia pickettii, some resistant to multiple antibiotics, in the patients.
Investigators traced the source to pharmaceutical company HLB Pharma and its laboratory, Laboratorio Ramallo. Argentina’s drug regulator, Anmat, confirmed bacterial contamination in both the deceased and in ampoules from two fentanyl batches prepared by the company. One batch was said to have been “widely circulated”, according to federal judge Ernesto Kreplak, who is leading the inquiry.
HLB Pharma’s owner, Ariel García Furfaro, denied the deaths were directly caused by his product, claimed his company had voluntarily withdrawn it from sale, and alleged the contamination had been “planted”.
Argentina patients speak
The patients had been hospitalised for unrelated conditions and were given fentanyl for pain relief or anaesthesia before contracting the multidrug-resistant infections. Authorities believe more than 300,000 ampoules were distributed across Buenos Aires province, Santa Fe, Córdoba, Formosa and Buenos Aires city. An estimated 45,000 were administered before the remainder were withdrawn and seized.
“Argentina has never experienced such a serious case. It is unprecedented,” said Adriana Francese, a lawyer representing four victims’ families.
Relatives have described the speed of the fatalities. “The fentanyl caused their death within days,” said Alejandro Ayala, whose brother Leonel died aged 32. The mother of 18-year-old Renato Nicolini, who died after a car accident and subsequent fentanyl complications, told Efe: “He began to improve little by little, and on the third day, they discovered he had pneumonia. His fever couldn’t be controlled, and seven days later, he died.”
The affected batches have now been recalled. “Contaminated ampoules are not circulating today,” Judge Kreplak said. However, the death toll continues to rise as more cases from recent months are examined.
No charges have been filed, but 24 people linked to the production and sale of the opioid have been named as suspects, had their assets frozen, and been banned from leaving the country. The investigation is focusing on manufacturing practices and quality control procedures.