Australia’s health authority says it has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna).
Compounding is when a trained health professional, usually a pharmacist, makes a medicine using raw ingredients. The Department of Health & Aged Care said it does not evaluate these – sold for the treatment of colic or wind in infants – for safety, quality and effectiveness, and that compounded medicines must be produced in line with the Pharmacy Board’s guidelines and professional practice obligations.
Various symptoms can happen within 30 minutes of giving a product containing belladonna, but they can also occur up to four hours later because of the way the ingredient slows down the gut, added the agency.
They might include:
• flushed and dry skin
• dry mouth
• dilated pupils
• rapid heartbeat
• inability to pass urine
• gut problems such as vomiting, cramps, constipation (due to the gut being slowed down)
• high temperature
• restlessness, agitation
• drowsiness, floppiness or poor feeding
• seizures.
How an infant will react also depends on how many doses they have received and the time between the doses.
“Health professionals should be aware that belladonna toxicity could be causing anticholinergic symptoms in an infant or young child receiving a compounded wind or colic product,” it warned.
TGA article – Compounded colic preparations containing Atropa belladonna (Open access)
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