Testosterone products and supplements pose a risk to women and children whether they are the ones using them or they are exposed to a man who is undergoing treatment.
Although testosterone is the primary sex hormone in males, it is present in all humans. Like men, women sometimes find that testosterone levels drop lower than normal, affecting various aspects of health and well-being. For this reason, a small percentage of women may be advised to use testosterone replacement to restore healthy testosterone levels.
However, anyone considering testosterone therapy should know that adverse effects are possible, both in men and women undergoing treatment and family members for whom accidental exposure may be a risk with today’s topical testosterone products.
Black-Box Warning for Secondary Exposure in Children
Accidental testosterone exposure in women and children who live or interact closely with men who are using topical testosterone drugs is a serious problem. That exposure typically occurs through contact with skin that has been treated with testosterone gels or other topical testosterone products. For this reason, the FDA requires that these products carry warnings on their labels to inform users of the dangers of accidental exposure and give users information on how to avoid it.
Two testosterone replacement gels, AndroGel and Testim, carry a black-box warning – the U.S. Food and Drug Administration’s (FDA) strongest warning – for secondary exposure in children. Because the gel is applied to the skin, children may come in contact with application sites or even leftover gel on unwashed clothes or towels.
The FDA warns:
- Children who are exposed to testosterone gel may suffer from inappropriate virilization, which is the development of male secondary sexual characteristics.
- Children should not have contact with the “unwashed or unclothed application sites.”
- Doctors and other providers should warn patients that testosterone products should be used as directed and to follow instructions for use carefully.
Patients using testosterone drugs are advised that after applying testosterone to the skin, the area should be allowed to dry for a few minutes, then covered completely with clothing. Hands should be thoroughly washed after application, and any area, such as a sink or counter, that may have been contaminated should be cleaned. Women and children should not touch skin to which testosterone has been applied, and clothing or linens that have come into contact with the area should be handled carefully.
In women, the same side effects that are possible with direct use can occur. Side effects reported in children who have come into contact with testosterone drugs include enlarged genitals, premature growth of pubic hair, increased self-stimulation and aggressive behavior.
While these effects typically fade when exposure stops, genitals may remain enlarged in some cases. Additionally, children exposed to testosterone drugs may experience advanced bone aging, which can result in children who stop growing prematurely and may be shorter in height as an adult than they might have been without testosterone exposure.
Women Who Need Testosterone Treatment
While medical science has been aware of the effects of diminishing production of estrogen and progesterone in women for a number of years, decreased testosterone, until recently, wasn’t often considered with regard to women’s health. However, in recent years, some doctors have begun supplementing testosterone in women, typically as part of a midlife hormone replacement regime to counter the symptoms of perimenopause and menopause.
Primarily, it is used to address symptoms related to sexual function, since it is thought that lower-than-normal levels of testosterone in women can affect sexual desire and responsiveness. Other symptoms of low testosterone in women can include muscle loss and/or weakness, fatigue, decreased bone density and depression.
Women who have symptoms that significantly impact health and quality of life and have testosterone level test results confirming low testosterone may benefit from testosterone replacement. However, it is important to note that testosterone therapy can have side effects in women, too.
These may include hair growth on the face or body, hair loss on the scalp, oily skin or acne, hoarseness or deepening of the voice, fluid retention, diminished breast size and increased clitoris size. Women who are pregnant or who could become pregnant should not take testosterone, since it can cause abnormal fetal development.
Another important thing that women considering treatment should consider is that there are no testosterone products that are FDA-approved for use in women. Doctors who prescribe testosterone for women may use a compounding pharmacy to formulate supplements or prescribe existing ones in smaller doses – an off-label use.
Testosterone products carry a Pregnancy Category X, which means women who are pregnant, may become pregnant or who are nursing should not use them. The drug may cause fetal harm if taken during pregnancy. Unborn and nursing babies may experience virilization, or abnormal male sexual characteristics.
Additionally, since testosterone treatment longer than six months in duration has not been studied, researchers do not yet know whether testosterone drugs can affect factors like risk of breast cancer, heart disease or blood clots in women.
If you’re a woman who has suffered testosterone-related health problems — or you have children injured by accidental exposure — please contact our Patient Advocates for assistance. Knowing how to proceed in such cases can ensure that you and your children have access to the care you need.