Medicines with soft gel capsules marketed for children

Safety advisory - choking risk for children

19 February 2014

Consumers and health professionals are advised that medicines that come in the form of soft gel capsules may pose a choking risk for children, especially those aged under five years.

Soft gel capsules are typically a gelatin-based shell, containing a liquid. They can be used as a dosage form for a variety of medicines, including complementary medicines, such as vitamins.

Soft gel capsules

In some cases, these medicines may have directions for use that say that they can or should be chewed. Even when chewed, soft gel capsules may pose a choking risk for children.

The TGA has published information for sponsors and potential sponsors of medicines supplied in the form of soft gel capsules marketed for children, advising them to restrict the use of those products to children aged 5 years or older.

Information for consumers

This advisory is precautionary. Medicines that come in the form of soft gel capsules are not necessarily unsafe products and the choking risk posed by these capsules is similar to that for many food items.

Moreover as the age of the child being given the medicine increases, the risk of choking reduces. As at 1 January 2014, the TGA has received no reports of choking on these types of products.

However, parents and caregivers are advised to be mindful of the risk of choking when medicines in the form of soft gel capsules are given to children, especially those aged under five years.

The TGA reiterates the importance of the following:

  • all medicines be kept out of reach of children
  • children be supervised when taking any medicine, with extra care taken when using medicines that come in the form of soft gel capsules
  • parents and caregivers follow the instructions for use for all medicines given to children.

If you have any questions or concerns about using medicines in the form of soft gel capsules for children, please contact a health professional, such as your general practitioner or pharmacist.

Information for health professionals

Health professionals are advised of the above information and should consider advising parents and caregivers of children accordingly.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.