February 22, 2013 – Health Canada reported that a 7-year-old girl experienced an anaphylactic reaction after being administered 4 drops of Cerumol to loosen earwax. Within four minutes, she had trouble breathing, collapsed into anaphylactic shock and was immediately taken to hospital where she was administered diphenhydramine (Benadryl). Upon discharge, she was given Benadryl for the next two days.
Cerumol eardrops are available from most pharmacies without a prescription. There is a warning on the box and in the patient information leaflet indicating that the product contains peanut oil - instructing patients with peanut and soya allergies not to use this product. It is important to note that the label on the box and the bottle lists peanut oil as a non-medicinal ingredient. Despite the warning, parents were unaware that Cerumol contained peanut oil.
Manufacturers are known to change the ingredients used in familiar products, and then again, different varieties and sizes of the same brand may contain different ingredients.
Health Canada is urging professionals to remind their patients with food allergies to always check the list of medicinal and non-medicinal ingredients of the health products, including topical preparations such as creams, ointments and ear drops and to always check for allergen warnings prior to purchasing and using any product.
Manufacturers are known to change the ingredients used in familiar products, and then again, different varieties and sizes of the same brand may contain different ingredients. If you are not sure of the ingredients, please check with your local pharmacist before purchasing.
People with peanut allergies should be aware that licensed Canadian natural health products and pharmaceuticals might be labelled as containing "arachis oil," which is another term for peanut oil. Arachis oil is an oily substance that aids lubrication of the cerumen plug (water based solvents cause swelling of cerumen).
Canada Vigilance Program
If you or any member of your family has suffered adverse reactions with allergen-containing natural health products and pharmaceuticals, Health Canada encourages you to report your incident to the Canada Vigilance Program by filling out a Canada Vigilance Program form (please scroll down to the Related Resources Section), or you can call them at 1-866-234-2345 and fax them at 1-866-678-6789.