Three patients who received polylaminin as part of a court order have died in Brazil, with deaths attributed to pre-existing medical issues, according to the producing laboratory.
In a concerning development, three patients who had received polylaminin, a substance currently undergoing safety testing by Brazil's National Health Surveillance Agency (ANVISA), have died in the states of Espírito Santo, Paraná, and Rio de Janeiro within the last ten days. The laboratory Cristália, responsible for the scientific research and production of polylaminin, reported that these deaths are not linked to the substance, emphasizing that they stemmed from the patients' existing health conditions rather than any adverse effects from the treatment.
According to Cristália, the first death occurred on January 28 due to pulmonary embolism, followed by a pneumonia-related death on February 1 in Paraná, and a case of septicemia that resulted in death on February 9 in Rio de Janeiro. The laboratory clarified that all three individuals were hospitalized and had experienced numerous medical complications during their treatment. Due to a confidentiality agreement between the hospital and the families, personal information about the deceased patients has been withheld from the public.
This incident raises significant questions about the safety and regulatory oversight of polylaminin, especially as it remains in the testing phase. The laboratory's insistence on the deaths not being related to the drug could be critical in addressing public and regulatory concerns. As more details emerge, the implications of these deaths could affect the ongoing research and future approval of the substance, highlighting the delicate balance between medical innovation and patient safety.
