The Medicine and Healthcare products Regulatory Agency has shut down production of an unlicensed medicine called GcMAF at a site in Cambridge and urged those who have bought the product – including it is believed some people with ME/CFS – to see their doctors.
The agency (MHRA) have also warned people who may have purchased GcMAF labelled as ‘First Immune’ from an online website or other unregulated sources.
Dr Charles Shepherd, medical adviser to the ME Association, commented: “We are aware that people with ME/CFS have been using this product. However, there is no evidence at present from clinical trials to show that it is a safe and effective form of treatment for ME/CFS.”
In a press release issued on February 3, MHRA said:
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. We are working with colleagues in other countries to alert them to the potential risks. Our investigations are ongoing and we 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.
The list of websites that people may have purchased GcMAF are:
MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.