The French medicines agency is recalling all batches of Pomalidomide Viatris in circulation, which is prescribed as part of treatment against bone marrow cancer. The ANSM indicated the action to be taken in a press release.
If you have bone marrow cancer and are taking Pomalidomide Viatris as part of your treatment, read the following information carefully. The National Medicines Safety Agency (ANSM) launched a recall on Monday January 20 of all batches of Pomalidomide Viatris “due to quality defect”. An anomaly was indeed spotted during an inspection. The Viatris laboratory informed the ANSM, which decided to carry out an emergency recall.
In its press release, the ANSM specifies: “We were informed by the Viatris laboratory of the discovery, during an inspection, of a very small quantity of powder containing the active ingredient outside the capsule, in certain blisters of packaging of Pomalidomide Viatris 1 mg , 2 mg, 3 mg and 4 mg (capsule).” And “this quality defect was found on a batch that was not distributed”the ANSM prefers to play the card of caution since “the risk of this anomaly occurring on previously distributed batches cannot be completely excluded”.
Patients invited to return their box to the hospital
For patients, the procedure is very simple: return their box of Pomalidomide Viatris to their hospital pharmacy for exchange. An instruction was also given to the pharmacists in question: “Quickly contact the patients concerned so that they are informed of this recall as quickly as possible.”
-A risk is also incurred for people, caregivers, caregivers, relatives of patients, who could handle these capsules as “pomalidomide is teratogenic” et “likely to cause malformations in the fetus”. A warning, therefore: “Women who are pregnant or of childbearing age should not come into contact with this product.”
published on January 21 at 4:00 p.m., Maeliss Innocenti, 6Medias
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