Key Findings: Anvisa‘s Concerns

Brazil’s National Health Surveillance Agency (Anvisa) has issued a strong warning against the use of testosterone in women for anything other than formally recognized medical indications. Specifically, Anvisa restricts testosterone use to the treatment of hypoactive sexual desire disorder (HSDD), emphasizing that it should only be administered after a thorough clinical evaluation. The agency cautions that using testosterone without a valid medical reason, based on self-prescribed dosages, or for non-therapeutic goals carries significant health risks.

This warning comes amid increasing reports of women seeking testosterone prescriptions or obtaining it through unregulated channels to address issues like low libido, improve body composition, or as part of anti-aging regimens. Anvisa explicitly states it has not approved any testosterone formulations specifically for use in women and does not recognize its use for aesthetic purposes, physical performance enhancement, or anti-aging claims.

Potential Health Risks Detailed by Anvisa

Anvisa’s statement outlines a range of potential adverse effects associated with off-label testosterone use in women, some of which can be severe and irreversible. These include:

• Virilizing Effects: Acne, hair loss, increased facial and body hair growth (hirsutism), enlargement of the clitoris, and irreversible deepening of the voice.
• Organ Toxicity: Potential for liver toxicity and the development of liver tumors.
• Psychological and Psychiatric Changes: Mood swings, aggression, and other mental health disturbances.
• Reproductive Health: Infertility.
• Cardiovascular Risks: High blood pressure, irregular heartbeats (arrhythmias), blood clots (embolisms and thrombosis), heart attack, stroke, and increased risk of mortality.
• Laboratory Abnormalities: Changes in cholesterol and triglyceride levels.

The agency stresses that these risks are heightened when testosterone is used outside of a medically supervised context for HSDD.

Context: Rising Testosterone Use and Regulatory Scrutiny

The increasing interest in testosterone therapy among women reflects a broader trend of seeking medical interventions to address sexual dysfunction and age-related changes. However, the scientific evidence supporting the widespread use of testosterone in women remains limited and ofen controversial.CNN brasil reported on the growing number of women in Brazil turning to testosterone to combat low sexual desire, highlighting the demand driving this issue.

Regulatory agencies worldwide are increasingly scrutinizing the off-label promotion and use of testosterone, particularly in populations where its benefits and risks are not fully understood. Anvisa’s warning aligns with similar cautions issued by health authorities in other countries, emphasizing the importance of evidence-based medicine and patient safety.

What is Hypoactive Sexual Desire Disorder (HSDD)?

Hypoactive Sexual desire Disorder (HSDD) is characterized by a persistent or recurrent deficiency in sexual fantasies and desire for sexual activity. It causes significant distress or interpersonal difficulty for the individual. Diagnosis requires a extensive evaluation to rule out other contributing factors, such as relationship problems, psychological issues, or underlying medical conditions. Testosterone therapy may be considered as a treatment option for HSDD in women *after* these other factors have been addressed and a clear diagnosis has been established by a qualified healthcare professional.

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