Contaminated fentanyl in Argentina update
In a follow-up on the outbreak linked to contaminated fentanyl in Argentina, the Ministry of Health reports based on information provided by the National Epidemiological Bulletin, as of May 16, 66 cases of infections with the bacteria Klebsiella pneumoniae metallo-beta-lactamase (MBL), extended-spectrum non-beta-lactamase (ESBL), and Ralstonia have been reported due to exposure to contaminated fentanyl produced by the firm HLB Pharma.
So far, 54 cases (81.8%) have been confirmed, and 12 cases (18.2%) are still under investigation.
The confirmed cases correspond to patients treated in Buenos Aires (18) and Santa Fe (36). In 63% of them (34 cases) the bacteria K. pneumoniae producing carbapenemases of type MBL was identified, in 20% (11 cases), K. pneumoniae MBL + Ralstonia spp and, in 17% (9 cases), the bacteria Ralstonia spp.
On May 7, a private healthcare facility in the province of Buenos Aires reported an outbreak of non-extended-spectrum metallo-beta-lactamase (ESBL) Klebsiella pneumoniae and Ralstonia in patients hospitalized in the Intensive Care Unit (ICU) between April and May. According to the facility's investigation, both pathogens were found in the culture of the fentanyl ampoules administered to the patients.
Among the investigation and control actions implemented, on May 8, ANMAT issued an alert indicating that the product "FENTANYL HLB / FENTANYL (CITRATE), concentration 0.05 mg/ml, in the pharmaceutical form of injectable solution, lot 31202, expiry SEP-26, presentation of 100 ampoules of 5 ml, Certificate No. 53,100" should not be used because it was under investigation for quality deviation.
On May 10, the Ministry of Health issued an alert to health facilities regarding control measures, surveillance, case definitions, sample referrals, and notification to the SNVS: “OUTBREAK UNDER INVESTIGATION POSSIBLY RELATED TO EXPOSURE TO CONTAMINATED FENTANYL”.