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The TGA has become aware that some measuring syringes supplied with Children's Panadol Baby Drops are incorrectly marked and this has the potential to lead to accidental overdoses.
The active ingredient in Children's Panadol Baby Drops is paracetamol. Paracetamol has been used in Australia for the relief of pain and fever since the 1950s and is available in many different forms for adults and children.
Paracetamol is safe and effective when taken as directed on the label. However, if taken either in overdose or in amounts that exceed the recommended dose for more than a few days, the unwanted effects can be severe.
All consumers should check any Children's Panadol Baby Drops syringes they have at home. If the dosing indicator does not begin from the bottom of the syringe near the tip do not use the syringe to measure out medicine (see image).
The issue only applies to the dosing syringes supplied with Children's Panadol Baby Drops and does not affect the quality of the accompanying medicine. Other products and dosing devices in the Children's Panadol range are not affected, including Children's Panadol Baby Drops that contain a dropper as the measuring device.
What if a faulty syringe has been used?
- Overdose should not occur if the product was used as directed (i.e. for less than 48 hours, unless on doctor's advice).
- Overdose may be a risk if there has been prolonged use (i.e. used four times per day for more than 48 hours).
- If prolonged use occurs, very young babies (less than three months old) those with certain edical conditions, such as liver disease, and those taking certain medications (such as anticonvulsants) may be at higher risk of harm.
What happens if there is an overdose?
- Paracetamol can be harmful to the liver if given in large doses (i.e. more often than four times per day or for longer than recommended)
- The harmful effects on the liver can be fatal if they are not detected and treated early.
- The harmful effects of large amounts of paracetamol on the liver are usually delayed so people may feel well for the first day after a paracetamol overdose but can become very sick after that.
- If treatment is given early enough, there are usually no permanent ill-effects.
Information for consumers
If you have purchased Children's Panadol Baby Drops you should take the product to your local pharmacy for checking prior to use.
What parents and guardians should know about paracetamol overdose:
- The harmful effects of large amounts of paracetamol on the liver are usually delayed, so children may feel well for the first day after an overdose but become very sick after that.
- Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
- If you think you have given too much paracetamol (overdose), contact the Poisons Information Centre (Telephone 131126) or your doctor, or go to the nearest hospital emergency department. Do this even if your child does not seem sick.
- Don't give paracetamol to infants, children or adolescents for more than 48 hours unless advised by a doctor.
Information for health professionals
If recommending the use of Children's Panadol Baby Drops, advise parents and guardians to be aware of this issue and to check any accompanying syringes
Be alert to the possibility that accidental overdose may exist when the product has been used more frequently or for longer than recommended.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA 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.