Infants’ Friend oral liquid has been recalled due to the presence of chloroform as an inactive ingredient.Credit:Therapeutic Goods Administration
Parents have been urged not to panic over the recall of a popular liquid colic remedy after it was found to contain low levels of chloroform.
Professor Paul Colditz, director of the Perinatal Research Centre at the University of Queensland, said while there was some risk, chlorination treatments meant most people were constantly exposed to small amounts of chloroform in their drinking water.
The Therapeutic Goods Administration on Wednesday issued a total recall of the popular product, which has been on the market since 1935.
The government regulator said it recently became aware that the liquid includes a small amount of chloroform as an inactive ingredient after being alerted by a member of the public.
Chloroform was used as a hospital anaesthetic until the 1920s, with diluted chloroform water routinely used as a preservative in pharmaceuticals until the mid-20th century.
The active ingredients of Infants' Friend are listed on the label but under TGA guidelines the manufacturer is not compelled to list excipients – inactive substances that serve as the vehicle for a drug.
A recall notice from Infants' Friend said chloroform was "used to aid the manufacturing process of dissolving the active ingredients (essential oils) into the product’s purified water base".
It stated that the product contains 74 micrograms of chloroform per mL of oral liquid, or 0.007mL of chloroform in a 100mL bottle.
"The likelihood that an infant would be exposed to levels of chloroform that might be harmful resulting in acute toxicity is very low as evidenced by the scarcity of adverse events reported in the past 85 years that the product has been supplied," the company stated in its recall notice.
The TGA was compelled to take action because the product label does not specify a maximum number of doses or duration of use, which may lead to prolonged use at harmful high doses.
"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," the TGA said in a statement.
"At high doses and/or following long-term use, chloroform is known to cause damage to the liver, kidneys and nervous system.
The TGA said it had not evaluated Infants' Friend oral liquid for safety, quality or effectiveness before now because it was a "grandfathered" medicine.
When a single national register of medicines was created in the early 90s, thousands of medicines already on the market were automatically placed on the TGA register with no new approval processes.
Professor Colditz, who is also president of the paediatrics and child health division of the Royal Australasian College of Physicians said while it would be "highly unlikely" that parents would be administering Infants' Friend at a level that could be dangerous, it was "entirely appropriate" for the regulator to recall the product.
"There’s almost certainly no baby been damaged according to this level of chloroform but nonetheless it presents a risk," he said.
Professor Colditz said not all babies who cry a lot have colic so it was important to seek expert medical advice to both exclude serious causes, and only use clinically-proven medical therapies in consultation with a doctor.
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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