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Key messages
- The Therapeutic Goods Administration (TGA) has received reports of serious side effects in infants given compounded wind and colic products containing Atropa belladonna (belladonna).
- Belladonna toxicity can cause symptoms in an infant that include dry mouth and skin, dilated pupils, inability to pass urine, floppiness and poor feeding (see Information for consumers, below).
- Parents and carers, as well as health professionals, should be aware of the potential for these serious side effects in infants and young children receiving such preparations.
- Parents and carers should seek medical attention immediately if an infant or young child shows symptoms of belladonna toxicity.
- Before giving a compounded colic preparation containing belladonna to an infant, parents and carers should consult a medical practitioner.
The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna). We are investigating the issue to determine whether actions are needed.
Compounding is when a trained health professional, usually a pharmacist, makes a medicine using raw ingredients.
The TGA does not evaluate compounded preparations sold for the treatment of colic or wind in infants for safety, quality and effectiveness. Compounded medicines in Australia must be produced in line with the Pharmacy Board’s guidelines and professional practice obligations.
The information that follows for consumers and health professionals is about the medicine safety concerns related to the use of compounded colic preparations.
Information for consumers
If you have given wind or colic drops containing belladonna to an infant or young child in your care, look out for the following symptoms:
- 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.
Seek urgent medical help if the infant or child is experiencing these symptoms.
The above symptoms can happen within 30 minutes of giving a product containing belladonna, but they can also occur up to 4 hours later because of the way belladonna slows down the gut. How an infant will react also depends on how many doses they have received and the time between the doses.
As a precaution, talk to a medical professional before giving any medicine or compounded preparation to an infant under 6 months of age or to any young child. Also, talk to a health professional if you have any other questions or concerns about this issue.
Information for health professionals
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. More information is available in the resources listed below.
Further resources
- NSW Health: Safety Notice: Risk of toxicity from ‘colic preparations’ containing belladonna
- Queensland Health: Factsheet: Reports of belladonna toxicity from colic preparation
- Australian Pharmacist: Belladonna toxicity linked to colic preparations
- The Royal Children’s Hospital Melbourne: Clinical Practice Guidelines- Anticholinergic Syndrome
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our monitoring of these products.
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.