The Federal Council of Medicine (CFM) prohibited the medical prescription of hormonal therapies with androgenic and anabolic steroids for aesthetic purposes, to gain muscle mass or improve sports performance.
According to the entity, the decision was taken due to the lack of sufficient scientific evidence to support the benefit and safety of the patient. The resolution was published this Tuesday (10) in the Official Gazette of the Union.
The measure highlights the lack of randomized clinical studies of good methodological quality that demonstrate the magnitude of the risks associated with androgen hormone therapy at levels above physiological levels, both in men and in women, in addition to the lack of scientific evidence of a clinical-pathological condition in women. due to low levels of testosterone or androgens.
Scratchs
By means of a note, the council warns of the potential risks of using inadequate doses of hormones and the possibility of harmful side effects, even with the use of therapeutic doses, especially in cases of hormone deficiency not properly diagnosed.
Among the possible adverse effects are cardiovascular ones, including cardiac hypertrophy, systemic arterial hypertension and acute myocardial infarction; atherosclerosis; hypercoagulable state; increased thrombogenesis and vasospasm; liver diseases such as drug-induced hepatitis, acute liver failure and hepatocellular carcinoma; mental and behavioral disorders, including depression and addiction; in addition to endocrine disorders such as infertility, erectile dysfunction and decreased libido.
According to the CFM, the perception is corroborated by the Brazilian societies of Endocrinology and Metabology, of Sports and Exercise Medicine, of Cardiology, of Urology, of Dermatology, of Geriatrics and Gerontology and by the Brazilian federations of Gastroenterology and Gynecology Associations and Obstetrícia, which issued a joint note demanding the regulation of the use of anabolic steroids and similar for aesthetic and performance purposes.
Resolution
The council’s resolution regulates that the medical prescription of hormone therapies is indicated in cases of proven specific deficiency, according to the existence of a causal link between the deficiency and the clinical condition, whose hormone replacement provides scientifically proven benefits, being “the doctor is prohibited from the prescription of drugs with an indication not yet accepted by the scientific community”.
The use of hormonal therapies with the aim of delaying, modulating or preventing aging remains prohibited.
The publication foresees the prescription of androgenic and anabolic steroids as justified for the treatment of diseases such as hypogonadism, delayed puberty, neonatal micropenis and cachexia, and may also be indicated in cross-hormone therapy in transgenders and, in the short term, in women diagnosed with desire hypoactive sex.
The Federal Council of Medicine also defines that, in the practice of medicine, the prescription and disclosure of hormones advertised as bioidentical in nano formulation or with commercial nomenclatures without proper scientific proof of clinical superiority for the intended purpose, as well as of selective androgen receptor modulators for any indication. The fence is in accordance with the understanding of the National Health Surveillance Agency (Anvisa).
Abuse
According to the council, the number of people using this type of medication illegally is growing. The CFM also reports an increase in the abusive administration of growth hormone (GH) by athletes, amateurs and professionals, as an ergogenic drug, which is why the hormone was included in the list of anabolic substances by Anvisa and in the list of prohibited drugs in the sport by the World Anti-Doping Agency.
“Ergogenic drugs tend to improve physical performance by delaying fatigue, boosting muscle mass gain (anabolic property) and fat breakdown (lipolytic property)”, highlighted the CFM.
The resolution also determines that the experimental adoption of any type of therapy not released for use in Brazil remains prohibited to the physician without the due authorization of the competent bodies and without the consent of the patient or his legal guardian, who must be duly informed.
The restriction also extends to the holding of courses, events and advertising with the aim of encouraging the use or supporting the possible benefits of androgen therapies for aesthetic purposes, muscle mass gain or improvement in sports performance.
“This item assumes relevance in view of the proliferation of extension activities, continuing education and postgraduate studies on hormone therapies whose basis is the training of professionals to prescribe hormones and other treatments that still lack scientific evidence”, concluded the council.