Cannabidiol and epilepsy in Brazil: a current review

ABSTRACT

Background: Cannabidiol (CBD) has become a promising therapeutic option in the treatment of epilepsy. Recent studies provide robust evidence that CBD is effective and safe. Limitations in current knowledge and regulatory issues still limit CBD use. CBD use regarding epilepsy types still lacks clear guidelines. Objective: To critically review the main current pharmacological features and clinical issues regarding CBD use in epilepsy, to provide current regulatory background regarding CBD use in Brazil, and to suggest a practical CBD therapeutic guide in Brazil. Methods: Non-systematic literature review (up to February 2022) of current concepts of CBD and epilepsy, including the authors’ personal experience. Results: Five pivotal trials have led to CBD approval as an adjunctive treatment for Dravet and Lennox-Gastaut syndromes, and for the tuberous sclerosis complex. Efficacy of CBD in other drug-resistant epilepsies remains not completely understood. CBD adverse event profile and drug interactions are better understood. CBD is well tolerated. In Brazil, CBD is not classified as a medication, but as a product subject to a distinct regulatory legislation. CBD is still not offered by the National Brazilian health system, but can be purchased in authorized pharmacies or imported under prescription and signed informed consent. Conclusion:  CBD is a recognized novel treatment for epilepsy. Future well-designed studies and public health strategies are needed to offer widespread access to CBD, and to improve the quality of life of people living with epilepsy in Brazil.

RESUMO

Antecedentes: O canabidiol (CBD) é uma terapêutica promissora no tratamento da epilepsia. Estudos recentes trouxeram evidências robustas sobre a eficácia e segurança do CBD. Lacunas no conhecimento atual e questões legais limitam seu uso. Não há consenso sobre o manejo do CBD nos diferentes tipos de epilepsia. Objetivo: Revisar criticamente os principais aspectos farmacológicos e clínicos atuais do uso do CBD em epilepsia e sugerir um guia terapêutico prático no Brasil. Métodos: Revisão não-sistemática da literatura até fevereiro de 2022 de conceitos atuais sobre CBD e epilepsia, associado a experiência dos autores. Resultados: Cinco estudos principais levaram à aprovação do CBD como tratamento adjuvante nas síndromes de Dravet, Lennox-Gastaut e na esclerose tuberosa. A eficácia em outras epilepsias fármaco-resistentes ainda não está bem estudada. Eventos adversos e interações medicamentosas são comuns. O CBD é bem tolerado. No Brasil, o CBD não é classificado como medicamento, mas como produto sujeito a diferente regras regulatórias. O acesso ao CBD ainda é restrito, e este não é fornecido pelo sistema público de saúde brasileiro. O CBD pode ser adquirido no Brasil em farmácias autorizadas ou por importação, sob prescrição especial e termo de consentimento informado. Conclusão: O CBD é uma realidade no tratamento da epilepsia. Estudos futuros e políticas públicas são necessários para permitir amplo acesso do CBD melhoraria da qualidade de vida de pessoas com epilepsia no Brasil.

Keywords:

Cannabidiol - Epilepsy - Efficacy - Safety - Brazil

Palavras-chave:

Canabidiol - Epilepsia - Eficácia - Segurança - Brasil

Authors’ contributions:

CAO: drafted the original manuscript and contributed to the study design; LHMC: revised the manuscript for intellectual content and designed the work.

Publication History

Received: 04 April 2022

Accepted: 29 April 2022

Article published online:
06 February 2023

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