Children exposed to topical testosterone risk ‘genital enlargement', MHRA warns
The medicines watchdog has warned that there is a “risk of harm” to children who are accidentally exposed to topical testosterone.
The Medicines and Healthcare products Regulatory Agency (MHRA) this week (January 25) said that pharmacists should advise patients to take steps to reduce the “risk of harm to children following accidental exposure”.
“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,” it warned.
Pharmacists should advise patients using topical testosterone to wash their hands after application, cover the application site and wash the site before physical contact with another person, it said.
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Topical testosterone products – gels or creams applied directly to the skin – are authorised to replace testosterone in men who do not produce sufficient natural levels of the hormone.
They are also used outside the licence for a range of conditions, including peri/post-menopausal symptoms in women.
Reports of harm to children
The MHRA received a report of a child who was “repeatedly accidentally exposed to the topical testosterone product that their parent was using”, it said.
This resulted in “increased growth and genital enlargement”, it added.
Clinical investigations confirmed that the child “had increased testosterone in their blood and that the topical testosterone product was the source”, the medicines watchdog continued.
“There are also literature reports and non-UK reports of premature puberty and genital enlargement in children who were repeatedly accidentally exposed to a topical testosterone product via transfer from an adult with whom they were in close contact,” it said.
How pharmacists can reduce the risk
Healthcare professionals such as pharmacists should tell patients to “take care that the testosterone product is not accidentally transferred onto the skin of someone else”, the MHRA advised.
“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,” it said.
They should also inform patients that accidental transfer can lead to increased blood levels of testosterone in another person, it added.
And patients should be informed of side effects to look out for if accidental exposure occurs – such as facial or body hair growth, deepening of the voice and changes to the menstrual cycle in adult women and accelerated height, genital enlargement, premature puberty and development of pubic hair in children – it said.
Healthcare professionals should “counsel patients on methods to reduce the risks of accidental exposure”, including:
- washing hands with soap and water after applying the product
- covering the application site with clean clothing such as a t-shirt once the product has dried
- washing the application site with soap and water “after the recommended time period following application has passed” before physical contact with another adult or child.
Product information warning
The Paediatric Medicines Expert Advisory Group of the Commission on Human Medicines recommended that a paediatric warning be added to the product information for topical testosterone products, following a review of the risks.
The MHRA has instructed manufacturers of the products to update the summary of product characteristics and the patient information leaflet to reflect these warnings and precautions, it said.
Anyone who suspects adverse reactions should report them via the Yellow Card scheme, it added.
It comes as the Department of Health and Social Care has issued two new serious shortage protocols for hormone replacement therapy, due to “significant ongoing disruption”.
