Case study: Bonjela and swollen tongue
Background information
An elderly woman was using Bonjela for tongue pain. After using Bonjela, the woman suffered from a swollen tongue which was so severe that it was considered to be a possible choking hazard. An ambulance was called for further help and they provided the patient with oxygen therapy.
The pharmacy assistant checked and no information regarding the potential for a swollen tongue, or other hypersensitivity reactions were listed in the Patient Information Leaflet (PIL) for Bonjela. The pharmacy assistant submitted a Yellow Card report to inform us of what happened to the patient and her concern that it might be linked with the use of Bonjela gel.
Investigation
During routine assessment of the Yellow Card report and considering the lack of information regarding this type of side effect within the product information leaflet (PIL), a detailed investigation was launched. It revealed four additional cases between 2001 and 2017, reporting swollen tongue with Bonjela. All four reports were related to adult patients. Two of the four patients were admitted to hospital as a result of the suspected reaction. A wider investigation revealed 29 Yellow Card reports with allergic type reactions. There were no reports of a swollen tongue in connection to Bonjela at the time of this report.
Response
The side effect was discussed in further detail by specialist teams. It was decided that the side effects experienced by the patients could have been caused by Bonjela.
Result
As Bonjela is available over the counter and contains an ingredient linked with salicylic acid, which is known to be connected to allergic type reactions, regulatory action was taken. The product information for Bonjela was updated by the pharmaceutical company with the addition of new warnings of hypersensitivity in the ‘undesirable effects’ section. The patient information leaflet was also updated to include a warning of unexplained wheezing or coughing, asthma, shortness of breath, difficulty breathing, itching, face, tongue or throat swelling which can all be signs of serious allergic reactions. Guidance on what to do if you experience any of these signs was also added to the patient information leaflet.
Additional information
Bonjela is an oral gel to treat common mouth ulcers and sores.
Oxygen Therapy involves breathing in air that contains more oxygen than normal through a mask or tube connected to a device in your home.
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