All batches of Pomalidomide, an anti-cancer drug from the Viatris laboratory, were recalled by the National Agency for the Safety of Medicines and Health Products (ANSM) on Monday January 20, 2025, due to a manufacturing defect.
Pomalidomide is a medicine used to treat multiple myeloma, a cancer that starts in plasma cells.
The Viatris laboratory launched this alert after discovering, during an inspection, “a very small quantity of powder containing active ingredient outside the capsule, in certain cells of packaging blister packs”, indicates the ANSM in its press release.
If this concerns a batch which has not been distributed, the ANSM has however preferred, as a precautionary measure, to recall all boxes of Pomalidomide in circulation of 1 mg, 2 mg, 3 mg and 4 mg (capsule).
What to do if you have a box of Pomalidomide?
Patients in possession of a box of Pomalidomide (all dosages) are therefore invited to return it to the pharmacy of the hospital where they are being treated, where it will be exchanged for them. But “do not stop or change your treatment without medical advice,” declares the ANSM.
If you notice the presence of powder outside the capsule in a pack of your medicine, do not open it.
-It is recommended to wear gloves and wash your hands thoroughly with soap and water after handling the pomalidomide blister pack or capsules.
Pregnant women or women of childbearing age should not come into contact with this product. Because the active ingredient of this medication is teratogenic, that is to say it can cause “serious malformations likely to lead to the death of the fetus in any pregnant woman who has been in direct contact with the product by ingestion, inhalation , contact with skin or eyes. »
To date, the Viatris laboratory assures that “no complaints related to the quality defect have been reported. No pharmacovigilance cases have been reported to us. »
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