Testosterone supplements and products create a danger to children and women, whether the side effects of testosterone are exposed to a male who is being treated or they are actually using it for themselves.
In males, the primary sex hormone is testosterone. However, it is present within all humans. Sometimes women, similar to men, experience a drop in testosterone levels to lower than normal, which affects well-being and various other health aspects. That is why it might be recommended for a small number of women to use a testosterone replacement in order to restore their testosterone to a healthy level.
However, anyone who is thinking about undergoing testosterone therapy needs to be aware of possible adverse side effects of testosterone, both in women and men who undergo treatment as well as family members who could be at risk due to accidental exposure given the widespread use of topical testosterone products these days.
Black-Box Warning For Testosterone Secondary Exposure For Children
Accidental testosterone exposure in children and women who interact or live with men who use topical testosterone drugs can potentially be a serious problem. Typically this exposure takes place through coming into contact with skin that is treated with a testosterone gel or other type of topical testosterone product. That is why the FDA requires that there being warnings on these product labels that tell users about the dangers of being accidentally exposed and provide users with information on how it can be avoided.
Testim and AndroGel are two different testosterone replacement gels that carry the black-box warning- which is the strongest warning by the FDA- for secondary exposure for children. The gel gets applied to the skin, so children can come into contact with gel leftover on unwashed towels or clothes or directly from application sites.
The FDA warns that:
Children who become exposed to testosterone gel might potentially experience inappropriate virilization, or develop male secondary sexual characteristics.
The FDA further warns that children shouldn’t have any contact with unclothed or unwashed application sites.
Patients should be warned by doctors and other health care providers about the side effects of testosterone and testosterone products need to be used as directed, and that instructions for use should be carefully followed.
It is recommended that patients that use testosterone drugs, after they have applied it to their skin, should allow the area to dry for a couple of minutes, and then cover it completely with clothing. After application hands should be washed thoroughly, and any areas that might have become contaminated like counters or sinks should be cleaned thoroughly. Children and women shouldn’t touch any skin that has had testosterone applied to it. Any linens and clothing that have been in contract with areas treated with testosterone should be handled very carefully.
The same potential side effects of testosterone that may occur with direct use also can occur in women. Reported side effects in children who have been in contact with testosterone products include aggressive behavior, increased self-stimulation, and premature pubic hair growth and enlarged genitals.
Typically, those effects fade after the exposure stops. However, in some cases, genitals might stay enlarged. Also, children who are exposed to testosterone products might develop advanced bone aging. This can cause a child to prematurely stop growing and as an adult might be shorter in height than they otherwise would have been if they hadn’t been exposed to testosterone.
Women In Need Of Testosterone Treatment
Although medical science has known of the effects that diminished production of progesterone and estrogen in women can cause for quite some time now, until recently, decreased testosterone wasn’t considered very often as a concern for women’s health. In recent years, however, some doctors have started to supplement testosterone in women. It is usually done within a midlife hormone replacement regimen in order to counteract menopause and Peri-menopause symptoms.
It is primarily used for addressing symptoms that relate to sexual function. This is due to the fact that it is believed that when testosterone levels are lower than normal in women that it can affect their sexual responsiveness and desire. Other symptoms for women having low testosterone levels include depression, decreased bone density, fatigue, muscle weakness and muscle loss.
Women with symptoms that are greatly impacting their quality of life and health, and whose results from testosterone level tests confirm that they have low testosterone levels, might benefit from testosterone replacement. It is however important to note that women can potentially experience side effects from testosterone therapy as well.
These side effects of testosterone might include increased clitoris size, diminished breast size, fluid retention, deepening or hoarseness of their voice, acne or oily skin, losing hair on the scalp or hair growth on the body or face. Testosterone shouldn’t be taken by pregnant women or women who might become pregnant because it can result in abnormal fetal development.
Women who are considering treatment also need to take into consideration that the FDA has not approved any testosterone products for women’s use. Doctors prescribing testosterone to women might utilize a compounding pharmacy for formulating supplements or prescribing ones that already exist but in smaller doses- which is an off-label use.
Pregnant Category X is carried by testosterone products, which means that women who are nursing, pregnant or might become pregnant shouldn’t take them. Fetal harm can take place if testosterone is taken by a pregnant woman. Nursing and unborn babies might experience abnormal male sexual characteristics or virilization.
Also, because testosterone treatment of over six months hasn’t been studied extensively, researchers don’t know at this point whether or not testosterone drugs may affect risk factors in women for such issues as blood clots, heart disease or breast cancer.
Please contact our Patient Advocates for help if you are a women suffering from the side effects of testosterone or you have children who have been exposed accidentally. Knowing what steps to take in these situations can help to ensure that your children and you have access to the proper care that you need.