Parents are being told to stop using Infants’ Friend Oral Liquid after the popular colic relief medicine was found to contain chloroform as an inactive ingredient.
The Therapeutic Goods Administration says it recently became aware that Infants’ Friend oral liquid includes a small amount of chloroform. “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,” the TGA outlined in a statement.
The investigation concluded that the safety of Infants’ Friend oral liquid isn’t acceptable due to the potential for infants to be exposed to intakes of chloroform that exceed a safe level. “This conclusion 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,” the TGA explained.
“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 ‘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.”
Infants’ Friend response
In a statement to Mum’s Grapevine, Infants’ Friend said it’s initiating the recall as a precautionary measure in conjunction with the Therapeutic Goods Administration.
“The recall is being conducted due to there being no limit to maximum frequency of dosage listed on the bottle’s labelling. An excipient (inactive ingredient) used to aid the manufacturing process, chloroform, may be consumed at levels above the tolerable daily intake if the product is used frequently at high levels. Intermittent and short-term use of the product is not expected to be harmful (which is usually the case when using this product for its intended purpose to treat the symptomatic relief of colic, wind or teething discomfort).
“Usage at a level at which the risk appears would be very unlikely. There have been no instances of any adverse health effects linked to the affected batches to date. Infants’ Friend has an exemplary safety record, with only three adverse health events ever linked to the product in its’ 85-year history, none of which have been directly linked to this issue or serious enough to trigger any action by the TGA.
As a precaution, the below batches are being recalled:
What should you do?
The TGA is recommending parents stop using Infants’ Friend and return the 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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