Misused, mydriatic eye drops, used in particular during a fundus, are associated with serious side effects, particularly in children, alerts the Medicines Agency which issues its recommendations to limit the risks.
Mydriaticum®, Skiacol®… Of the serious, sometimes fatal, side effects are observed when using mydriatic eye drops in childrenespecially newborns, infants and premature babies, alert the Medicines Agency (ANSM) in a press release dated April 5, 2023. In question, the passage of these eye drops in the blood and damage to the digestive, cardiovascular and/or central nervous systems. Eye drops are used to dilate the pupil (mydriasis) whena glimpse or resting the eye to measure refraction.
What are the side effects of mydriatic eye drops in children?
Adverse effects can be different depending on the type of eye drops. They usually occur within 20 to 30 minutes after administration and symptoms are transient, improving in 4 to 6 hours but which can last up to 12 to 24 hours.
► Non-serious effects : after the exam, dilation of the eye may persist for several hours and the child can present redness on the face and dryness in the mouth.
► Serious effects: neurological, cardiovascular and digestive disorders following the passage of the drops into the blood (most often when several mydriatic eye drops are administered successively). Seek immediate medical attention if these symptoms appear:
- Sudden and high fever (rarely severe except in the event of an overdose: in this case, consult the child’s doctor immediately);
- Change in the behavior of the child: agitation, hyperexcitability or sudden drowsiness, and more rarely, hallucinations;
- Confusion, memory loss that may manifest in children as learning difficulties or attention disorders;
- Headaches, dizziness, balance disorders, and more rarely, convulsions;
- Rapid heartbeat or high blood pressure;
- Digestive disorders (swelling in the abdomen, loss of movement of the muscles of the intestine (ileus), partial or total blockage of the intestine (occlusion) in newborns and premature babies).
What to do in case of overdose?
If the child shows signs of overdose after accidental ingestion or repeated administration of eye drops (rapid heartbeat, episodes of spasms and loss of consciousness (convulsions), loss of coordination, signs of respiratory depression such as slow and shallow breathing …):
- Flush one or both eyes with lukewarm water
- Consult the doctor immediately the child or your pharmacist or contact the poison control center in your department. If your child’s situation requires it, you will be referred to an emergency service.
- Secondly, it is also possible to report side effects directly through the national reporting system
What is the list of mydriatic eye drops sold in France?
In France, there are two types of mydriatic eye drops that are used in children:
- Anticholinergic eye drops: antimuscarinics with atropine, cyclopentolate (Skiacol®) and tropicamide (Mydriaticum®)
- Type 1 alpha-mimetic eye drops with phenylephrine (Neosynephrine®).
What precautions should be taken to avoid the risks?
The Medicines Agency recommends, to avoid these adverse effects and prevent the risk of overdose (accidental or by repeated administration):
- Do not leave eye drops within reach of children to avoid any risk of accidental ingestion (a bottle can be confused with a small bottle, etc.)
- Check the storage rules indicated in the leaflet: some eye drops must be stored in the refrigerator. If in doubt, ask your doctor or pharmacist
- Remember to note the date of opening on the bottle or packaging
- Scrupulously respect the methods of administration of eye drops and the dosage adapted to the age of the child, as well as the time intervals between each eye drop indicated in the prescription. If in doubt, ask your doctor or pharmacist
- After administration of eye drops, press the inner corner of the child’s eye for 1-2 minutes and wipe the child’s cheek. This avoids any ingestion or absorption by contact with the skin and thus limits the passage of the product into the bloodstream.
- After putting the eye drops on him, watch your child carefully during 30 minutes
Are they available with or without a prescription?
Mydriaticum® and Skiakol® are available sur prescription (List I). Neosynephrine® is available without a prescription.
Source : How to limit the occurrence of adverse effects of mydriatic eye drops in children? ANSM, April 5, 2023