Problem Or Issue:
The Health Products Regulatory Authority (HPRA) has been made aware of a warning issued by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in relation to an unlicensed medicine, Globulin component Macrophage Activating Factor (GcMAF) labelled as “First Immune”.
During a recent inspection of the unlicensed facility in the UK where GcMAF was being manufactured, the MHRA identified a number of concerns in relation to the blood plasma starting material used in the manufacture of GcMAF, in addition to concerns over the sterility of the product and the conditions under which the product was being manufactured.
Although there is no evidence at this time that GcMAF has been supplied to the Irish market, the product was being sold through a number of European websites, and as such there is the potential that Irish patients may have purchased the unlicensed product online or via other unregulated sources.
Actions To Be Taken:
Any patients or other members of the public who are using or have used GcMAF are advised to immediately stop using the product and consult their doctor. Patients should consult their doctor even if they have already stopped taking the product. When consulting their doctor, patients may find it useful to take a copy of this notification with them.