MHRA Warns Against GcMAF Made in Unlicensed Facility in Cambridgeshire, UK

GcMAF (Globulin component Macrophage Activating Factor), a blood product, claims to treat a range of conditions including cancer, HIV and autism. People who have bought this product should speak to their doctor.

Investigators from MHRA carried out an unannounced inspection of a production site in Milton, Cambridgeshire, after the medicines regulator in Guernsey raised concerns in relation to the product. The blood plasma starting material being used to make this drug stated “Not to be administered to humans or used in any drug products”. It was concluded that the production site does not meet Good Manufacturing Practice (GMP) standards and there are concerns over the sterility of the medicine being produced and the equipment being used. There are concerns that the product may be contaminated.

More than 10,000 vials were seized at this site and production of this unlicensed medicine has now ceased. These products were sold through various European websites and UK patients may have bought it from one of these websites. MHRA is working with colleagues in other countries to alert them to the potential risks. Their investigations are ongoing and they have received no reports to date of side effects caused by this product.

Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards said: "These products may pose a significant risk to people’s health. Not only were the manufacturing conditions unacceptable but the originating material was not suitable for human use. GcMAF products labelled as ‘First Immune’ are not licensed medicines and have not been tested for quality, safety or effectiveness. People should not start treatment with these specific products. It is important that patients currently taking these products seek their doctor’s advice as soon as possible. People should continue taking prescribed medicines and follow the advice of their doctor.

"The advice is, do not buy medicines online from an unregistered pharmacy as you don’t know what you are getting, where it came from or if it’s safe to take. The dose could be too high or too low, or the product may be contaminated.

"We would advise anybody needing treatment to seek professional medical advice and not to buy medicines from unauthorised sources."