The Pierre Fabre laboratory is recalling certain batches of a drug against osteoarthritis following the identification of a risk of bacterial contamination.
“To date, no pharmacovigilance cases have been reported.” On July 7, the National Medicines Safety Agency (ANSM) issued a product recall for two batches of the drug Structum due to quality defect. “This recall of certain boxes of this drug follows the highlighting of non-compliant results during the verification of the microbiological quality of the finished product”details the report.
This recall is due to the potential presence of bacterial contamination by two substances: enterotoxin and cereulide toxin. It concerns boxes of 60 capsules of Structum 500 mg bearing the mention batches G20078 or G20079available in pharmacies since January. “In case of ingestion of a contaminated capsule, the patient may experience diarrhea or gastrointestinal disorders, even nausea and vomiting”, warns the ANSM. If, for the time being, no case of pharmacovigilance has been reported, the patients concerned must stop their treatment and return the boxes to the pharmacy.
What conduct to adopt?
If you have already taken contaminated capsules, you may have had diarrhea or gastrointestinal disorders in the hours following the taking of the drug, explains the ANSM. Usually these symptoms are “benign and transient”, reassures the agency. On the other hand, the situation may be more worrying for immunocompromised people who have taken capsules from the boxes concerned. “The risk of possible bacterial dissemination that could lead to serious adverse effects such as meningitis or endocarditis cannot be ruled out”, warns the report. It is therefore imperative that they consult a doctor.