Chile's Public Health Institute warned of two new risks linked to leuprorelina-containing drugs, used for advanced prostate cancer treatment. These include liver issues like fatty liver and severe skin reactions that can be fatal. The review drew from international evidence, with no local cases reported in the past 12 years.
Chile's Public Health Institute (ISP) completed a safety review of drugs containing leuprorelina, a key active ingredient in treating advanced prostate cancer. Prompted by a 2024 alert from Spain's Agency for Medicines and Health Products, it pinpointed two emerging risks: metabolic changes including non-alcoholic fatty liver disease and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Leuprorelina works by lowering sex hormone production, notably testosterone, to halt tumor progression. In Chile, it is marketed as Eligard in long-acting injectable forms. Fatty liver involves fat buildup in the liver unrelated to alcohol, potentially causing inflammation and hepatic damage, particularly in those with diabetes, overweight, or metabolic syndrome. Skin reactions stem from immune-mediated damage leading to rashes, blisters, and skin peeling, starting with fever and malaise, and demanding prompt intervention to enhance outcomes.
While the ISP's national adverse reaction database shows no linked cases over the past 12 years, the authority will require laboratories to revise informational leaflets for healthcare providers and patients, in line with the European Medicines Agency's guidance. Immediate medical help is urged for signs like fever with eruptions or skin pain, and treatment should not be stopped independently. Disclosing pre-existing metabolic conditions is essential prior to starting therapy.