Alerta do Canadian Adverse Reaction Newsletter, Volume 23 - Issue 1 - January 2013
Health Canada received a report of a 7-year-old girl who experienced an anaphylactic reaction after being administered Cerumol ear drops by a parent. According to the report, she received 4 drops of Cerumol ear drops in each ear to loosen earwax. Within 4 minutes, she required her "blue inhaler" normally used for her asthma problems (product not specified), stating that it was too hard to breathe. She then collapsed, went into anaphylactic shock and was taken to the emergency room but was not hospitalized. The treatment she received while in the emergency room was not specified; however, after discharge she was administered diphenhydramine (Benadryl) at home for a couple of days. The report indicated that she had recovered. It was also reported that she had a known peanut allergy and that she was a regular user of ciclesonide (Alvesco) and montelukast (Singulair) for the treatment of her asthma.
Cerumol ear drops include a warning on the box and in the patient information leaflet indicating that the product contains peanut oil and instructs patients allergic to peanuts and soya not to use it. The label on the box and the bottle lists peanut oil as a non-medicinal ingredient. Despite this, the parent reported that she was unaware that Cerumol contained peanut oil.
Health professionals are encouraged to remind patients with food allergies to always check the list of medicinal and non-medicinal ingredients of health products, including topical preparations, such as creams, ointments and ear drops, and to consistently check for allergen warnings prior to using any product. Manufacturers sometimes change the ingredients used in familiar products. Different varieties and sizes of the same brand may contain different ingredients. Patients with peanut allergies should also be aware that licensed Canadian natural health products and pharmaceuticals may be labelled as containing arachis oil, which is another term for peanut oil.
Health Canada encourages the reporting of adverse reactions suspected of being associated with allergen-containing natural health products and pharmaceuticals to the Canada Vigilance Program.
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