The drug, known as high-lipase pancreatin, helps cystic fibrosis patients to digest their food by replacing missing enzymes which break down fats and other substances. But the Committee on Safety of Medicines, the Government's drug-safety watchdog, has received nine reports (two unconfirmed) of narrowing of the large bowel in children with cystic fibrosis since the drug was launched in April 1992. Six of the children needed surgery to remove part of the bowel.
Doctors in Liverpool were first alerted to the problem after five children with cystic fibrosis who developed the rare bowel problem were referred to Alder Hey Children's hospital over a 10-week period. All had changed treatment from a standard-strength to high- strength pancreatin drug. Dr David Heaf, a consultant paediatrician at Alder Hey, said last night that more cases were expected as the doctors became aware of the link.
In a letter received this week by doctors and pharmacists, Professor Michael Rawlins, chairman of the CSM, said that all cystic fibrosis patients who had taken the drug should be reviewed and changed to other (standard strength) pancreatin products until CSM investigations were complete.
About 4,000 adults and children with cystic fibrosis take the drug. There are four brands, all of which have been associated with at least one case. Manufacturers of Creon 25000, Nutrizym 22, Pancrease HL, and Panzytrat 25000 have been asked to withdraw all advertising and promotional material on the drugs.
Professor Rawlins said: '. . . the benefits now need to be considered in the context of the possible risk of colonic strictures (bowel narrowing) requiring major surgery.'
Standard-strength pancreatic enzymes have been used for many years by cystic fibrosis patients without problems, but they needed to take scores of capsules - 100 or more in some cases - each day. Two years ago, high-strength capsules were introduced which meant that patients could halve the number they took. These were especially suitable for children.
Dr Martin Scott, of the Cystic Fibrosis Research Trust, said yesterday that there was no proof as yet that the high-strength enzyme preparations were responsible, however the parents of children with cystic fibrosis and adult patients who were concerned should see their doctor.
Dr John Peter, managing director of Duphar which makes Creon 25000, said that the cases were 'an enigma' and that high-strength capsules had been used in Germany since 1986, and the United States since 1988, without problems.Reuse content