Several batches of the drug Structum, indicated in the treatment of osteoarthritis (hip and knee), have been recalled due to possible bacterial contamination, reports the Medicines Agency (ANSM). Which batches are affected? What if you have it at home?
Lots of Structum® drugs manufactured by the Pierre Fabre Pharmaceuticals laboratory and indicated in treatment of osteoarthritis of the hip and knee were recalled, says the Medicines Agency (ANSM) in a press release dated July 7, 2022. These drugs are available with or without a prescription in pharmacies, for people aged 15 and over. This recall follows the identification ofa risk of bacterial contamination of the drug, highlighted during a quality control. To date, no case of adverse effects has been reported. What are the batches concerned by this reminder? What should patients do in possession of these drugs? List and action to take.
Which osteoarthritis drugs are affected by the recall?
It’s about Structum®a medicine manufactured by the Pierre Fabre Médicament Laboratory which contains a substance naturally present in cartilage and bone: Sodium chondroitin sulfate. It is used in the treatment symptomatic of osteoarthritis of the knee or hip. It belongs to thehe family of “slow-acting anti-arthritics”: the effect of this medicine is slow to appear, relief usually only appears after 1 to 2 months treatment. It is a drug not subject to medical prescription. The lots affected by the recall are as follows:
- Batch G20078 medicine Structure 500 mg, capsule (box of 60 – expiry date 11/2024).
- Batch G20079 medicine Structure 500 mg, capsule (box of 60 – expiry date 11/2024).
The batches concerned are available in pharmacies since January 2022.
What symptoms can they cause?
Immunocompromised people who have taken capsules from the boxes concerned should consult a doctor.
In the event of ingestion of a contaminated capsule, the patient may present certain symptoms, warns the ANSM, such as:
- Of the diarrheal disorders (linked to the possible presence of “enterotoxins”)
- Of the gastrointestinal disorders (linked to the possible presence of “cereulide toxin”)
- Of the nausea and vomiting
These symptoms are usually benign and transients. Nevertheless, immunocompromised people who have taken capsules from the boxes concerned should consult a doctor because of the risk of bacterial dissemination which can lead to serious adverse effects such as meningitis or endocarditis which cannot be ruled out.
What should patients do?
If you are in possession of a box of 60 capsules of Structum 500 mg bearing the mention of batches G20078 or G20079, we ask you stop using your medicine and of return your box (or boxes) to the pharmacyindicates the ANSM.
What should pharmacists do?
The Medicines Agency asks pharmacists to contact the patients to whom they have dispensed boxes of these 2 batches (G20078 and G20079), available in pharmacies since January 2022 for:
- inform them of the situation and ask them to check if they have already used their treatment
- ask them to interrupt it if necessary
- in all cases to bring their box(es) back to the pharmacy
Source : Patient recall for two batches of the drug Structum 500 mg, capsule (box of 60) due to a quality defect, ANSM, July 7, 2022.