The death toll from the administration of medical-use fentanyl to hospitalized patients has risen to 68. The scandal from earlier this year was distributed in health centers mainly in the provinces of Santa Fe and Buenos Aires, followed by Buenos Aires city.
The case made headlines in May after nine people were confirmed to have died of an infection caused by a contaminated batch of fentanyl produced by pharmaceutical company HLB Pharma and its laboratory Laboratorio Ramallo. Argentine food and drug regulator ANMAT ordered all health centers in Argentina to stop using their fentanyl batch, and ordered the companies to halt all production, measures that remain in place to date.
Patients were infected by bacteria Klebsiella pneumoniae MBL and Ralstonia Pickettii after having been administered with fentanyl to treat various affections at numerous institutions. The drug, which is a powerful synthetic opioid, acts as an analgesic and anesthetic used to treat severe pain for people who have just had surgery or are in advanced stages of cancer.
Since May, La Plata Federal Judge Ernesto Kreplak, from the Buenos Aires province judiciary, has been carrying out an investigation that aims to trace the full number of victims and those responsible.
Outlets such as the EFE news agency have reported that the judiciary has recorded 68 fatal victims so far, an additional 20 confirmed victims now formally informed by authorities. The Herald was not able to independently confirm the number with sources from various offices.
The latest National Epidemiology Bulletin, published on July 28, stated that there were 67 registered infected people and 48 dead. Of the total number of patients that were administered the contaminated fentanyl batch, 46 were from Santa Fe, 19 from Buenos Aires province and two from Buenos Aires city, the Argentine capital.
A breakdown of the district of residence of each of the victims was not provided in the epidemiology bulletin. However, a man from Córdoba reportedly appears in the list of 20 additional victims found by the Buenos Aires province judiciary, according to Infobae.
The bulletin states that, between May 8 and July 25, the Health Ministry was able to confirm 67 cases of infection linked to the contaminated fentanyl in 10 hospitals from Buenos Aires province, BA city and Santa Fe.
A case from Neuquén was dismissed given it did not comply with the requirements to be considered part of the case, and suspicious cases in other 7 institutions in Buenos Aires and Santa Fe provinces are under investigation. “The rest of the country’s provinces did not inform suspicious cases for the moment,” the bulletin said.
The document added that the cases confirmed so far were patients hospitalized between February 10 and May 9, except for one who began medical treatment in mid-December. No additional cases were notified after the Epidemiology Directorate issued an alert on May 10, following the ANMAT’s order to halt the use of the batch.
“The total of the deceased cases had been administered the aforementioned batch of fentanyl,” the report said. However, it clarified that whether the cause of death is directly related to the contaminated medication “is still under investigation,” and added that all infected patients had been hospitalized for other reasons and were administered fentanyl in order to treat their affections.
Determining whether there are more victims and if there have been cases in other provinces is an ongoing issue for the judiciary and health authorities. The efforts of the investigation, the epidemiology report said, “are centered around grasping the outbreak’s magnitude and extension” and finding whether suspected cases are also related.
Laboratorios Ramallo, which produced the contaminated batch, was already on the ANMAT’s radar before the first case of contamination was reported by a hospital. In February, the regulation agency had issued a warning against the laboratory and ordered it to stop production due to “significant deficiencies” in its quality management, which the entity described as “serious and critical.”
In June, ANMAT also withdrew operation permits from ALFARMA, a drug distribution company with links to HLB Pharma after finding “very serious” deficiencies in their storehouse in Rosario, Santa Fe.