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."
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance