MHRA Drug Alerts

The following section/document has been added/updated

Subscription type: Drug Alerts

Title: Class 2 Drug Alert (Action within 48 hours): Janssen-Cilag Ltd - Velcade 3.5 mg powder for solution for injection - EL (11)A/29

Summary: Janssen-Cilag Ltd is recalling all remaining stock of specific batches of Velcade 3.5mg powder for solution for injection due to concerns that acceptable levels of sterility assurance during manufacture cannot be guaranteed. Any remaining stock of these batches should be quarantined.

You can find the section/document here: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON135019

 

The following section/document has been added/updated

Subscription type: Drug Alerts

Title: Class 2 Drug Alert (Action within 48 hours): Pierre Fabre Médicament - Busilvex 6mg/ml concentrate for solution for infusion - EL (11)A/30

Summary: Pierre Fabre Limited is recalling all remaining stock of specific batches of Busilvex 6mg/ml concentrate for solution for infusion due to concerns that acceptable levels of sterility assurance during manufacture cannot be guaranteed. Any remaining stock of these batches should be quarantined.

You can find the section/document here: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON135021

 

Clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy (including: haematological malignancies such as acute myeloid leukaemia, Hodgkin’s disease, and B-cell lymphocytic leukaemias; myelodysplastic syndrome; solid tumours; and melanomas). There seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma—the authorised indication. Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON134927