Pancreatic enzyme products should warn of pig virus risks, US panel says

Thursday 4 December 2008
Sue Sutter - Washington editor

Labelling for Solvay's Creon (pancrelipase delayed-release) and other pancreatic enzyme products (PEPs) that are approved as drugs should warn about the potential human risks from swine viruses, a US FDA advisory panel unanimously recommended on December 2nd.

The labels should state that all porcine-derived PEPs have the potential to contain animal viruses and pose a risk of human infection, although to date there is no evidence of this having occurred. PEPs, which are used to treat pancreatic exocrine insufficiency, are currently marketed as nutritional supplements in the US and their packaging lacks any information about viral contamination risks. With their labelling recommendations, members of the antiviral drugs advisory panel sought to strike a balance between warning about the theoretical risk of infection without scaring patients away from using the therapies.

The FDA convened the panel to discuss viral issues and risks to patients taking PEPs. Although they are medically necessary products, manufacturing processes cannot completely eliminate all viruses from porcine-derived PEPs without destroying the enzymes' efficacy, the FDA said. While the risk of transmitting disease from porcine-based drugs to humans appears to be low, it nevertheless exists, and swine populations are infected with known and perhaps unidentified viruses. The agency sought the panel's advice on how to better quantify and mitigate the viral risks.

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