The popular colic medication that many parents swear by has been urgently recalled as it contains a very toxic chemical.
The Therapeutic Goods Administration (TGA) has released a recall of the medication stating:
“Infants’ Friend oral liquid includes a small amount of chloroform as an inactive ingredient.”
“When used at high doses, Infants’ Friend oral liquid can expose children to levels of chloroform that are higher than the level established to be safe. However, intermittent, short-term use is not expected to be harmful.”
All batches of the oral liquid, sold at pharmacies, are being recalled.
Unacceptable level
They said that the safety of Infants’ Friend oral liquid was unacceptable “due to the potential for infants to be exposed to intakes of chloroform that exceed a safe level”.
The organisation also took into consideration “that the product label did not specify a maximum number of doses or duration of use, which may lead to prolonged use at high doses.”
“At high doses and/or following long-term use, chloroform is known to cause damage to the liver, kidneys and nervous system. The established safe level of intake for chloroform is based on studies in animals and include wide safety margins.”
Infants’ Friend oral liquid is a “registered complementary medicine used to relieve colic, during teething and to keep bowels regular. It is labelled for use in infants from birth up to one year of age.”
Grandfathered Medicine
The TGA notes that Infants’ Friend oral liquid is a ‘grandfathered’ medicine, which means that it was available in Australia prior to 1990.
“As a grandfathered medicine, the TGA has not evaluated Infants’ Friend oral liquid for safety, quality or effectiveness.”
“Further regulatory actions are being considered to ensure any future supply of this medicine meets the TGA’s high standards for safety, quality and effectiveness,’ the TGA said.
What Should I Do Now?
The TGA recommends that you discontinue using Infants’ Friend oral liquid and you can return any remaining product to the place of purchase for a refund.
If you have any questions or concerns about this issue, talk to your health professional or contact Infants’ Friend Pty Ltd customer service on 1800 981 403.
If you suspect your infant has had an adverse effect to this product, please report it to the TGA.
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