Anvisa (National Health Surveillance Agency) banned the advertising of gestrinone and products that contain this substance in their formula, whether industrialized or manipulated.
Popularly known as the “beauty chip”, gestrinone is a steroid hormone with anabolic actions.
Due to its possible androgenic effects, such as decreasing fat mass and increasing muscle mass, the substance has been used by women in search of improved physical and aesthetic performance.
Anvisa’s decision was published in the Diário Oficial da União on December 23rd.
Alexandre Hohl, president of the Department of Female Endocrinology, Andrology and Transgender at Sbem (Brazilian Society of Endocrinology and Metabolism), said that the decision of the regulatory agency was correct.
The doctor explains that, at first, the device with gestrinone was used to treat endometriosis. However, there are no studies on the safety and efficacy of this substance for the treatment of endometriosis through implants.
He explained that gestrinone began to be studied for the treatment of endometriosis orally in the late 1970s. For this purpose, registration was granted by the regulatory agency for 24 months in the 1990s, but was not renewed.
The phenomenon of using the substance for esthetic purposes began about eight years ago and has been increasing in an overwhelming way. Currently, there are hundreds of doctors teaching courses on how to implant the “beauty chip”.
“We use medicine to treat illnesses, gestrinone is being used out of vanity. A substance in which the risk is infinitely greater than the benefits. The side effects are proportional to the doses used. Acne may appear, hair growth, oily skin, voice change, the person may stop menstruating, have difficulty getting pregnant and even [numa eventual gravidez, risco de], fetal malformation,” he reported.
Before this decision by Anvisa, Sbem had already taken a stand, in November, on the use and abuse of gestrinone implants in Brazil. The document had been sent to Anvisa, CFM (Federal Council of Medicine) and AMB (Brazilian Medical Association).
At the time, Sbem informed that it did not recognize gestrinone implants as a therapeutic option for the treatment of endometriosis, it vehemently rejected its use as an anabolic steroid for aesthetic purposes and to increase physical performance, and asked the regulatory authorities to increase the inspection of use inadequate use of these hormonal implants in the country.
In a technical note, sent in response to Sbem, the regulatory agency informed that there are no medicines containing the active pharmaceutical ingredient gestrinone with valid health registration in Brazil. There are also no registration requests in its database awaiting analysis or evaluation by the technical area.
He also said that it is not possible to claim that these products are effective and safe, which poses a risk to public health.
And he pointed out that these are irregular products that have not passed through the scrutiny of the technical areas of GGMED (General Management of Medicines and Biological Products).
Hohl also said that the regulatory agency was ready to place the anabolic steroid on the C5 list, which regulates steroids in the country. Thus, it may be subject to special control in the country and would have greater inspection.
.
Chad-98Weaver, a distinguished author at NewsBulletin247, excels in the craft of article writing. With a keen eye for detail and a penchant for storytelling, Chad delivers informative and engaging content that resonates with readers across various subjects. His contributions are a testament to his dedication and expertise in the field of journalism.
