topical testosterone (Testogel): risk of harm to children following accidental exposure

Last edited 01/2023 and last reviewed 02/2023

Premature puberty and genital enlargement have been reported in children who were in close physical contact with an adult using topical testosterone and who were repeatedly accidentally exposed to this medicine (1)

• to reduce these risks, advise patients to wash their hands after application of topical testosterone, cover the application site with clothing once the product has dried, and wash the application site before physical contact with another adult or child

• when prescribing topical testosterone, inform patients of the potential consequences if it is accidentally transferred to other people
• inform patients that accidental transfer can lead to increased blood testosterone levels in the other person
• advise patients of the possible effects should accidental exposure occur in adult women (facial and/or body hair growth, deepening of voice, changes in menstrual cycle) or children (genital enlargement and premature puberty, including development of pubic hair)
• counsel patients on methods to reduce the risks of accidental exposure, including washing their hands with soap and water after application, covering the application site with clean clothing (such as a t-shirt) once the gel has dried, and washing the application area with soap and water before physical contact with another person
• encourage patients to be vigilant about implementing measures to minimise risk, to be alert for signs of accidental exposure, and to seek medical advice if accidental exposure is suspected
• report suspected adverse drug reactions associated with topical testosterone on a Yellow Card

Reference:

• Drug Safety Update volume 16, issue 6: January 2023: 2.