Serious health concerns have been raised about the use of toothache gels on teething infants, prompting calls for new warning labels.
US health officials this week warned parents about the dangers of teething remedies that contain numbing ingredient benzocaine and asked manufacturers to stop selling their products intended for babies and toddlers.
The Food and Drug Administration (FDA) also said it wanted companies to add new warnings to products intended for adults.
In Australia, oral gel products containing benzocaine, such as Oral-eze and Nyal Toothache Drops, are regulated as over-the-counter medicines but are not allowed for use in children.
The Therapeutic Goods Administration (TGA) on Friday said it was aware of the FDA warning.
"The TGA will review the information from the FDA to see whether any action is required in the Australian context," a spokesperson said in a statement.
According to the FDA, various gels and creams containing benzocaine can cause rare but deadly side effects in children, especially those younger than two-years-of-age.
Benzocaine has been linked to a rare blood condition that interferes with an oxygen-carrying protein that can cause deadly breathing problems.
Symptoms include shortness of breath, headache and rapid heart rate.
FDA Commissioner Scott Gottlieb said it had been warning about the products for a decade but said reports of illnesses and deaths have continued.
"We urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain," Mr Gottlieb said.
