© Andrzej Tokarski
– The National Medicines Safety Agency announced the recall of “all batches of Pomalidomide Viatris
The alert has been issued. The National Medicines Safety Agency (ANSM) recalled, Monday January 20, all lots of Pomalidomide from the Lyon laboratory Viatris due to a quality defect, according to a press release. During a routine inspection, the manufacturer discovered in a batch of this anticancer treatment a “very small quantity of powder containing active ingredient outside the capsule, in certain cells of packaging blister packs”.
This powder, potentially harmful to health, was found in the cells of the packaging blister. Note that the discovery concerns only one batch. The Medicines Safety Agency thus uses the precautionary principle pour recall all boxes in circulation of Pomalidomide of 1, 2, 3 and 4 mg. “The risk of this anomaly occurring on previously distributed batches cannot be completely excluded”we can read in the press release.
-Vials of amoxicillin thrown away for simple packaging defects?
Possible alternatives
For the 2 500 patients who take this medication in France, they are invited to return them to the pharmacies of the hospitals where they are treated. “Do not interrupt your treatment under any circumstances,” warned the ANSM. “Alternatives to Pomalidomide Viatris are available to ensure continuity of patient care», added the agency.
Finally, the ANSM recommends that patients affected by the recall wear gloves during each handling, remove them carefully to avoid any contact with the product and wash their hands carefully with soap and water afterwards. . She further emphasizes that pregnant women and women of childbearing age should not handle the boxes. In question: the teratogenic nature of the active ingredient of this medication, that is to say likely to cause serious malformations likely to lead to the death of the fetus.
