A massive investigation has been launched in Argentina after at least 96 people, and possibly more, are thought to have died after being treated with medical-use fentanyl that was tainted with bacteria, reports The Guardian.
The official death toll stands at 87, and a judicial source said nine further deaths were now being probed.
The alarm was first raised in May, when dozens of hospital patients suffered serious bacterial infections. Strains of the bacteria Klebsiella pneumoniae and Ralstonia pickettii – some of which were resistant to multiple antibiotics – were detected in the patients.
Investigators said the source was fentanyl, traced to local company HLB Pharma and its laboratory, Laboratorio Ramallo.
Tests carried out by Argentina’s drug regulator, Anmat, confirmed bacterial contamination in the deceased and in ampoules from two fentanyl batches prepared by the company – one of which had been “widely circulated”, according to federal Judge Ernesto Kreplak, who is leading the investigation.
HLB Pharma owner Ariel García Furfaro denied that the deaths could be directly attributed to his product, claiming that if the ampoules were contaminated, someone had “planted” the contaminant.
The patients had been admitted to hospitals for unrelated conditions and were given the drug for pain relief or anaesthetic, before becoming infected with the multidrug-resistant bacteria.
Authorities say the contamination may have affected more than 300 000 ampoules distributed across Buenos Aires province, Santa Fe, Córdoba, Formosa and Buenos Aires city; an estimated 45 000 had been administered before the remainder were withdrawn and seized.
The human toll has been severe, and the death toll continues to climb as investigators analyse more cases of patients who have died in recent months after receiving the medication.
No charges have yet been filed, but the court has named 24 people involved in the manufacture and sale of the opioid as suspects.
They have been banned from leaving the country and had their assets frozen.
Investigations are looking at how the contaminated batches were manufactured and what quality controls were in place – which officials say will be very important to determine responsibility.
Fentanyl is between 50 and 100 times more powerful than morphine.
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