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Don't let "Low T" lead to harm in kids

What isn't emphasized enough about these products is that their use can lead to adverse effects in children who are accidentally exposed to the drug. And that's not hard to do since it easily gets on your hands, fingers, clothing, and bed sheets when applied. Then, people forget to wash their hands and forget that kids can absorb the drug upon contact.

Don’t let “Low T” lead to harm in kids

In this photograph taken on Friday, Sept. 11, 2009, Basil Irwin applies AndroGel testosterone gel at his home in Hygiene, Colo. Irwin says that with testosterone replacement therapy he feels much more energetic, has better libido and in general has an improved sense of well being. (AP Photo/The Longmont Times-Call, Richard M. Hackett)
In this photograph taken on Friday, Sept. 11, 2009, Basil Irwin applies AndroGel testosterone gel at his home in Hygiene, Colo. Irwin says that with testosterone replacement therapy he feels much more energetic, has better libido and in general has an improved sense of well being. (AP Photo/The Longmont Times-Call, Richard M. Hackett)

By Mike Cohen

Could it be “Low T?”

By now you’ve probably heard this line or otherwise seen a multitude of TV or newspaper ads for testosterone gel products. Increasingly, drug manufacturers have been tapping into this billion dollar market aimed at men over 40, which is when men sometimes start to feel the signs of aging and decreased desire for sexual relations. The gel is easy to use. It’s applied once daily to the shoulders or upper arms. AndroGel can also be applied to the abdomen.

Testosterone of course is the male hormone in the body that is primarily responsible for the normal growth and development of male sexual and reproductive organs. It’s important in maintaining bone health, energy levels, mood, and sexual desire. If men have low testosterone levels, doctors may prescribe one of the widely advertised testosterone gel products such as AndroGel 1% and Testim 1% to restore normal levels of testosterone.

What isn’t emphasized enough about these products is that their use can lead to adverse effects in children who are accidentally exposed to the drug. And that’s not hard to do since it easily gets on your hands, fingers, clothing, and bed sheets when applied. Then, people forget to wash their hands and forget that kids can absorb the drug upon contact. Testosterone can also cause harm to a pregnant woman’s developing fetus and can cause the development of masculine characteristics in children and women.

A few years ago the Food and Drug Administration (FDA) noted several cases of adverse effects in children. These occurred because of skin-to-skin contact with a person using the gel.

Two young sisters whose father used the gel were exposed to AndroGel through clothing and sheets on the bed. The girls experienced pubic hair growth among other symptoms. In another case a 16-month-old boy had an enlarged penis with erections and even pubic hair. The father was using the gel for about a year and slept in the same bed as the child, sometimes hugging the baby on his chest.

Other children in FDA’s report ranged in age from 9 months to 5 years and had signs of enlarged reproductive organs, increased sexual feelings, growth of pubic hair, advanced bone age, and aggressive behavior. In most cases, but not all, the adverse effects went away when the child was no longer exposed to the drug.

In 2009, FDA told drug manufacturers to include a boxed warning in the labeling of their products. There is also a MedGuide that pharmacists are supposed to dispense along with prescriptions for these products - like this one for Testim. But despite stronger warningswe are still seeing occasional reports of accidental exposure.

Men using these products should talk with their doctor, nurse, or pharmacist about the proper use of this medicine. To avoid hurting children or a developing fetus, follow these steps when you use testosterone gel products: Wash your hands with soap and water after every use. Cover the area with clothing once the gel has dried. Wash the area thoroughly with soap and water if there will be skin-to skin contact with another person.

Consider asking your doctor if you can use the patch form of the drug or one of the other forms such as the roll-on or a tablet that dissolves between your cheek and tongue.

About this blog
Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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