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.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.