Deadly Fentanyl Contamination in Argentine Medical Supplies Leads to Over 50 Fatalities
Argentina is currently grappling with its worst drug contamination scandal in history, involving the pharmaceutical company HLB Pharma and its laboratory, Laboratorio Ramallo. The contamination, linked to two batches of fentanyl, has resulted in 69 cases and an official death toll of 51.
The saga began when a hospital contacted the Ministry of Health and ANMAT (National Administration of Medicines, Food and Medical Technology) after tests pointed to fentanyl as the culprit in a series of unexplained deaths. Investigations revealed that the contaminated fentanyl was produced by HLB Pharma.
By 27 May, ANMAT was ordered to collect all doses from three fentanyl batches produced by the company. The orders included the discovery of metal pieces inside pill blisters, a mix-up of morphine and diclofenac sodium, and the sale of falsified critical equipment during the Covid-19 pandemic, as well as the distribution of falsified dopamine and the intravenous anesthetic propofol using an expired authorization of Surar Labs.
The contamination is not limited to fentanyl. At least three cases were related to microbial growth in the drugs, including metronidazole. Researchers in the Concordia region reached out to ANMAT after six breast cancer patients were infected with Ralstonia mannitolilytica, which they managed to trace to tainted dexamethasone from the HLB Pharma group.
The National government suspended Gabriela Mantecon Fumado, director of ANMAT's National Institute of Medicines (INAME), as she was the one who allegedly ignored a March report about the quality control failures and non-compliance with manufacturing standards at HLB Pharma and Laboratorio Ramallo, prior to the contaminated fentanyl situation.
Judicial authorities are investigating close to 100 deaths associated with the drug. Judge Ernesto Kreplak ordered the detention of nine of the charged individuals. Among those detained are the company's owner, Ariel García Furfaro, his two brothers, Diego and Damián García Furfaro, his mother and grandmother, Nilda Furfaro and Olga Arena, who are the company's primary stockholders, and the managers and manufacturing supervisors of Ramallo Laboratory.
The prosecutor has ordered a criminal investigation into the actions of ANMAT officials who were responsible for preventing this case. It is worth noting that in the years prior to the contaminated fentanyl situation, ANMAT had issued warnings about quality control failures and non-compliance with manufacturing standards at HLB Pharma and Laboratorio Ramallo, and consequently suspended production licenses and conducted inspections to enforce corrective actions.
As the investigation continues, at least 14 previous ANMAT recall orders against HLB Pharma and its lab were found, dating back to 2019. The prosecutor's office charged 17 individuals in relation to the scandal last week. García Furfaro's lawyer declined to comment. A week later, ANMAT prohibited the use, distribution, and commercialization of all HLB Pharma products.
The nation awaits the outcome of this ongoing investigation, hoping for improved regulations and oversight in the pharmaceutical industry to prevent such tragedies in the future.
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