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The National Medicines Safety Agency has given the alert: batches G20078 and G20079 of the drug Structum should not be consumed, following the identification of a risk of bacterial contamination. The boxes of the batches in question have since been recalled across France.
Batches G20078 and G20079 of the drug Structum 500mg (boxes of 60) were recalled by the Pierre Fabre Médicament laboratory in a press release from the ANSM on July 7. The cause ? A quality defect revealed during a microbiological quality control of the product, which could lead to possible bacterial contamination in patients. The drugs concerned have been available in pharmacies since January 2022 and their expiry date corresponds to November 2024.
Possible risks
Available with or without a prescription, Structum 500 mg capsules are prescribed for patients over the age of 15 with osteoarthritis of the hip or knee.
“In the event of ingestion of a contaminated capsule, the patient may experience diarrheal disorders (linked to the possible presence of “enterotoxins”) or gastrointestinal disorders (linked to the possible presence of “cereulide toxin”), or even nausea and vomiting”writes the ANSM.
In immunocompromised patients, the risk is more serious since the possible bacterial dissemination could lead to “serious adverse effects such as meningitis or endocarditis”.
Only batches G20078 and G20079 are affected by this defect, and the ANSM wanted to specify “that no case of pharmacovigilance related to the quality defect has been reported to date”.
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Recommendations to follow
If you have boxes of 60 capsules of Structum 500 mg marked “batch G20078” Where “batch G20079”, stop your treatment and return the boxes to the pharmacy. The batches concerned have been available there since January 2022.
“If you have taken contaminated capsules before, you may have experienced diarrhea or gastrointestinal disturbances within hours of taking the medication but are usually mild and transient. Nevertheless, immunocompromised people who have taken capsules from the boxes concerned should consult a doctor because of the risk of bacterial dissemination”advises the ANSM.
Pharmacists are asked to quickly contact patients to whom they have given medicines from the batches in question, explaining the situation to them.