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Patients may be at risk from possible viruses in pig glands used to make Brussels-based Solvay’s pancreatic enzyme product Creon, according to the US Food and Drug Administration.
Creon is intended for patients with exocrine pancreatic deficit, a rare condition defined by a lack of enzymes needed to digest food. These are sourced from the pancreatic glands of pigs, which can transmit viruses such as influenza and hepatitis.
Although pigs in the US and Europe are vaccinated against some viruses, they are not protected against others. Patients with cystic fibrosis, an inherited disease, generally take such enzymes for life.
All pancreatic enzyme manufacturers were ordered by the FDA to conduct clinical trials over concerns in the 1990s that they might cause colon damage. They have until April 2010 to win approval or they must stop sales.
Although the FDA is currently reviewing Solvay’s product, “there are numerous other manufacturers of (pancreatic) products that have similar and perhaps greater concerns” it has said.
Creon is approved in more than 70 countries and saw 2007 global sales of €191 million, less than 2% of Solvay revenues of €9.6 billion last year.
Copyright Press Association 2008