Europa se prepara para liberar cannabis para tratar epilepsia em crianças

Claudia Wallin, correspondente da RFI em Estocolmo

Na Suécia, um novo medicamento à base de cannabis vai começar a ser utilizado em breve no tratamento de formas graves de epilepsia em crianças a partir de dois anos de idade. Recém-aprovado pela agência reguladora de medicamentos da Europa, o Epidiolex é um óleo derivado da planta da maconha, que pode reduzir significativamente as crises de convulsões em crianças afetadas pelas síndromes de Dravet e Lennox-Gastaut.

A nova droga é uma versão farmacológica certificada do canabidiol, ou óleo CBD – um produto que, apesar de não ter uma certificação precisa e que em muitos casos é fabricado por meio de processos artesanais, há tempos é comercializado na internet. Desenvolvido pela britânica GW Pharmaceuticals, o Epidiolex tornou-se, no ano passado, o primeiro medicamento derivado da cannabis a ser aprovado nos Estados Unidos pela agência americana de controle de alimentos e medicamentos (FDA).

O medicamento tem como principal componente o canabidiol (CBD), um dos elementos químicos encontrados na planta da cannabis. A agência reguladora de medicamentos da Suécia (Läkemedelsverket) ressalta que o Epidiolex não contém tetraidrocanabidinol (THC), o ingrediente psicoativo da maconha que pode provocar alterações mentais no usuário.

Aprovação na Europa

A Agência Européia de Medicamentos (EMA) recomendou a aprovação do uso do Epidiolex no fim de julho. A aprovação final caberá à Comissão Europeia, que em geral acolhe as recomendações da agência reguladora de medicamentos do bloco europeu. A expectativa é de que a aprovação final ocorra dentro de um mês, quando o Epidiolex deverá estar disponibilizado para venda em todos os países europeus.

Os peritos recomendaram a aprovação do Epidiolex com base em três estudos que mostraram que ele reduz em até 50% a frequência de convulsões em crianças que sofrem das síndromes de Dravet e Lennox-Gastaut.

A síndrome de Dravet é uma condição genética rara, que se manifesta no primeiro ano de vida de uma criança com uma série de convulsões febris, e que com o passar do tempo provoca espasmos musculares involuntários e pode evoluir para crises convulsivas que chegam a poder ameaçar a vida do paciente. Crianças que apresentam a condição geralmente têm dificuldades de desenvolver a fala e as habilidades psicomotoras, além de hiperatividade e problemas em se relacionar com outras pessoas.

A síndrome de Lennox-Gastaut é caracterizada por múltiplas convulsões, e costuma se manifestar também na infância, entre os três e cinco anos de idade. Quase todas as crianças com esta síndrome apresentam problemas de aprendizado e deficiência intelectual. Muitas desenvolvem de forma tardia habilidades como engatinhar e sentar, e na vida adulta necessitam de apoio contínuo nas tarefas do dia-a-dia.

Efeitos colaterais reduzidos

Os efeitos colaterais mais comuns observados nos testes clínicos do Epidiolex em pacientes são cansaço, redução do apetite e problemas de sono. Segundo a FDA, a agência americana de controle de alimentos e medicamentos dos Estados Unidos, a droga também pode afetar o fígado, embora na maioria dos casos as consequências sejam danos leves. Nos casos mais graves, no entanto, os efeitos podem incluir náuseas, vômitos e dores abdominais. A FDA também adverte que, como ocorre geralmente com todas as drogas utilizadas no tratamento da epilepsia, o risco mais sério é a possibilidade de o paciente desenvolver depressão e até mesmo pensamentos suicidas.

Apesar disso, a agência reguladora americana afirma que as crianças que participaram dos testes com a nova droga apresentaram uma melhora drástica em sua qualidade de vida. Segundo o autor de um dos estudos com o Epidiolex, Richard Huntsman, após tomar o novo medicamento algumas crianças começaram a conversar ou engatinhar pela primeira vez, além de apresentar grandes melhoras em sua capacidade de comunicação.

Com a aprovação do Epidiolex, a agência reguladora americana adverte que tomará medidas enérgicas para coibir a venda ilegal de óleos CBD que não possuam a certificação necessária. “Comercializar produtos não aprovados, com dosagens e formulações incertas, pode dificultar o acesso de pacientes a terapias reconhecidas para o tratamento de doenças sérias e em alguns casos fatais”, diz a FDA em sua página na internet.

Uso difícil no Brasil

No Brasil, a regulamentação sobre o uso da cannabis medicinal começou em 2015, com a publicação de uma resolução que liberou a importação do CBD para consumo próprio. Os médicos passaram então a ter autorização restrita para receitar o uso de canabidiol para epilepsias de difícil controle: apenas pacientes que já tentaram outros tipos de tratamento de epilepsia podem fazer o pedido de autorização de compra.

O processo ainda é difícil para o paciente, que além de precisar de um relatório médico também deve cumprir várias etapas para obter a autorização da Agência Nacional de Vigilância Sanitária (Anvisa) para a importação do canabidiol. Uma vez obtida essa autorização, o paciente pode comprar o produto em sites internacionais, e em seguida deve solicitar a permissão de entrada do produto junto à Receita Federal.

Mas o problema principal é que a maioria dos derivados de maconha importados pelo Brasil não contém indicações sobre a concentração de canabidiol ou de THC, o componente da planta da cannabis que tem efeitos psicotrópicos.

Em 2017, a Anvisa aprovou o primeiro remédio à base de cannabis no Brasil – o Mevatyl, que é indicado para tratar espasmos relacionados à esclerose múltipla em adultos. Em março deste ano, a Justiça Federal brasileira determinou que medicamentos à base de cannabis fossem incluídos pela União na lista dos remédios disponibilizados no Sistema Único de Saúde (SUS), após três ações ajuizadas pelo Ministério Público Federal na Bahia. Uma dessas ações tinha por objetivo garantir o fornecimento de um tipo de óleo de cannabis para um rapaz de 27 anos, portador de epilepsia.

Mais recentemente, o diretor da Anvisa, William Dib, disse que até o final deste ano deverá ser publicada a legislação que autoriza o plantio de maconha para uso medicinal no Brasil. Ele observou, no entanto, que a consolidação de uma indústria de plantio da maconha em território brasileiro demandará tempo. A maconha medicinal só poderá ser vendida a instituições de pesquisa e fabricantes de medicamentos. A erva não poderá ser comercializada para pessoas físicas. O transporte será feito em veículos especiais e por empresas especializadas.

21 de Agosto de 2019

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