Anvisa restricts polylaminin use following patient deaths

Brazil’s National Health Surveillance Agency (Anvisa) has tightened restrictions on the compassionate use of polylaminin, an experimental substance intended to treat spinal cord injuries. The decision follows reports of nine deaths among 119 patients who received the treatment through compassionate use protocols.

Under the new regulations, access is limited to patients with complete spinal cord injuries occurring within the last 72 hours, specifically affecting the thoracic region between vertebrae T2 and T10. Previously, authorizations were granted for injuries occurring up to three months prior and across various spinal segments. Anvisa stated the change was necessary due to uncertainties regarding the substance's safety and efficacy.

Researcher Tatiana Coelho de Sampaio, who developed the substance, has criticized the move, arguing that the narrow window and specific spinal requirements significantly hinder patient access to experimental treatment.

Cristália, the pharmaceutical company responsible for the substance, maintains that its pharmacovigilance investigations found no causal link between the deaths and the treatment. The company also noted that while a Phase 1 clinical trial was approved in January, the study has not yet commenced.