MHRA warns that GcMAF blood product could be contaminated

Published: 3-Feb-2015

After an inspection of the unregulated manufacturing facility in Milton, Cambridgeshire, UK

The UK's Medicine and Healthcare products Regulatory Agency (MHRA) has warned that a blood product manufactured at a site in Milton, Cambridgeshire, UK could be contaminated.

The regulator has advised people who have purchased a medicine called GcMAF and labelled as 'First Immune’ from an online website or other unregulated sources to consult their doctor.

GcMAF (Globulin component Macrophage Activating Factor) claims to treat a range of diseases including cancer, HIV and autism.

The MHRA carried out an unannounced inspection of the site, after the regulator in Guernsey raised concerns about the product. The blood plasma starting material being used to make the drug stated that it was 'not to be administered to humans or used in any drug products'.

The MHRA said 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 also concerns that the product may be contaminated.

GcMAF products labelled as ‘First Immune’ are not licensed medicines and have not been tested for quality, safety or effectiveness

The MHRA seized more than 10,000 vials of GcMAF at the site and production of the medicine has now ceased. These products were sold through various European websites.

The regulator is working with colleagues in other countries to alert them to the potential risks and its investigations are ongoing. So far there have been no reports 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.'

The MHRA's advice is not to buy medicines online from an unregistered pharmacy or unauthorised source.

You may also like