The very small quantities of trimetazidine found in the batch in question, a substance not included in the composition of Daflon, do not, however, present “any risk for patients who may have been exposed to it”, assures the drug safety agency.
L’National Agency for the Safety of Medicines and Health Products (ANSM) published this Monday, August 12, the recall of a batch of Daflon, a treatment used for venous circulation disorders (heavy legs, pain, and restlessness) and functional signs linked to hemorrhoidal crises.
The boxes concerned are Daflon 500 mg, from Servier laboratories, from the batch 6068122The recall is due to the presence of traces of trimetazidine, a medicinal substance not included in its composition but used to treat angina in adults.
Bring the boxes back to the pharmacy
Patients with a box with the affected batch number are therefore invited to return it to their pharmacy for replacement. “Pending the exchange of your box, your treatment can be interrupted without risk,” writes the ANSM.
The organization indicates that if in doubt, you can return the box to your pharmacist who will check the batch number. Pharmacists are also invited to contact people who may hold the affected batches “in order to present them with the reasons and modalities of the recall.”
“No risk for patients”
“To date, no pharmacovigilance cases related to this quality defect have been reported,” the agency assures, adding that “investigations are currently being carried out” to determine its origin.
“According to the analyses carried out by the laboratory on this batch, the very small quantities of trimetazidine found do not present a risk for patients who may have been exposed to it,” the ANSM emphasizes.
According to AFP, for the third consecutive year, Daflon remained the Servier group’s top drug, with sales reaching 594 million euros for the 2022/23 financial year, according to its financial results published in February.
