Surveillance. The National Medicines Safety Agency (ANSM) announced on Monday, January 20, the withdrawal of “all batches of Pomalidomide Viatris due to a quality defect” detected after an inspection.
During a check of this anti-cancer drug, “a very small amount of powder containing the active ingredient” was found “outside the capsule, in certain cells of the blister.”
The ANSM specifies that “it cannot be completely excluded” that this anomaly also occurred in previous batches of the product. Hence a withdrawal “as a precautionary measure.”
Patients with a box are asked to promptly return the product to their hospital pharmacy to receive a new one. For their part, pharmacists “are invited to quickly contact patients” to inform them of the withdrawal.
“We warn caregivers, caregivers and relatives of patients about the risks associated with handling the capsules from the batches in question: pomalidomide is teratogenic, so it is likely to cause malformations in fetuses,” specifies the health authority. .
The “teratogenic” character implies potential serious malformations of the fetus in “any pregnant woman who has been in direct contact with the product through ingestion, inhalation, contact with the skin or eyes.”
Source: BFM TV
