Use authorized by the Municipality only for epilepsies in Dravet and Lennox-Gastaut syndromes and in tuberous sclerosis complex, reducing the possibilities compared to the 2014 standard

In a resolution published on Friday 14 in the Official Gazette (DOU), the Federal Council of Medicine (FCM) limited the possibilities of prescription of the cannabidiol (CBD), a compound obtained from the plant cannabis sativa (marijuana) and prohibited doctors from giving lectures and courses on the use of this and other cannabis products outside of the scientific environment.
For the standard just publishedthe council authorizes the medical profession to prescribe the product only for the treatment of childhood and adolescent epilepsy associated with Dravet and Lennox-Gastaut syndromes and tuberous sclerosis complex – and only in cases where the patient has not shown good results with conventional treatments.
The resolution highlights that doctors are prohibited from prescribing cannabidiol “for a therapeutic indication other than that envisaged” in the new standard, except in clinical trials approved in the country.
In previous resolution, 2014, the board gave more general guidance on the issue. In the regulation, the CFM authorized the compassionate use of the substance for epilepsy in childhood and adolescence refractory to conventional therapies, without, therefore, limiting its use only to certain pathologies.
Although in the previous resolution the agency did not authorize its use for conditions other than epilepsy, it was not categorical in prohibiting prescriptions for indications other than those provided by the standard, which is why some experts indicate a setback in the resolution.
The council maintained the article already contained in the previous resolution in which the doctor is prohibited from prescribing cannabis in nature for medical use, as well as any derivative other than cannabidiol.
According to the CFM, the new guideline was defined “after scientific reviews on therapeutic applications and the safety of cannabidiol use”. After the evaluation, the CFM claims to have observed “the existence of positive results from the CBD prescription in cases of seizure syndromes, such as Lennox-Gastaut and Dravet, but negative results in several other clinical situations”.
The council also stipulates that patients undergoing cannabidiol treatment, or their legal guardians, should be informed about the potential risks and benefits of the treatment and sign an informed consent form.
For the Brazilian Cannabis Association Esperança Support (Abrace), the resolution is controversial and the “fences interfere with the execution of the treatment of several patients and prohibit the dissemination of cannabis knowledge that is important to doctors and patients”.
The main controversy highlighted by the resolution’s critics is the fact that there are already 18 medical cannabis products approved in Brazil by the National Health Surveillance Agency (Anvisa), including one drug indicated for the treatment of stiffness associated with multiple sclerosis.
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Source: Terra

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