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Patient safety

Medicines regulator warns over unlicensed blood plasma product

An unlicensed medicine sold via European websites and which claims to treat HIV, cancer and autism, contains blood plasma never intended for human use, the UK medicines safety regulator has warned.

Labelled as “First Immune”, the medicine contains Globulin component Macrophage Activating Factor (GcMAF). The product may be additionally contaminated because equipment used in its manufacture at an unlicensed site in Cambridge, UK, may be unsterile, the Medicines and Healthcare products Regulatory Agency (MHRA) says.

The MHRA recommends that anybody who has used the product should visit their doctor as soon as possible.

More than 10,000 vials of the drug were seized following an unannounced inspection at the site by MHRA officers. The swoop followed concerns originally raised by the medicines regulator in Guernsey. The site failed to meet MHRA good manufacturing standards and has been closed down.

“GcMAF products labelled as ‘First Immune’ are not licensed medicines and have not been tested for quality, safety or effectiveness,” says Gerald Heddell, the MHRA’s director of inspection, enforcement and standards. “Not only were the manufacturing conditions unacceptable but the originating material was not suitable for human use.”

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067785

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