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Dear expert team,

I would like to give my 5-year-old daughter, who has CF, Legalon® to support her liver. The package insert says that there are no tests for children under 12 years of age available and that one should therefore avoid the drug for them. Can I give it to my daughter? Do you have any experience with it?

Kind regards.

you would like to give your 5-year-old daughter, who has cystic fibrosis (CF), Legalon® to support her liver. You are asking whether there is any experience with Legalon® therapy with younger children, since the package insert says that there are no tests about effectiveness and tolerance with children under 12 years of age.

Legalon® is an extract from the milk thistle fruit (silymarin) that is approved for the treatment of toxic liver damage, chronic hepatitis and cirrhosis of the liver. No pharmaceutical company has conducted clinical trials on the tolerance and therapeutic effectiveness in children under 12, so that the use of all drugs containing silymarin is limited to patients older than 12. Drugs containing silymarin are not used routinely for children in conventional gastroenterology and hepatology. The same is true for children with CF, but also for patients with CF in general. There are no well-grounded scientific studies on the application of silymarin compounds in CF patients. There are individual observations on silymarin therapy in children and adolescents with cirrhosis of the liver in the pre-transplantation stage and after transplantation. Generally, therapy for those patients was done by request of the parents and not at the recommendation of the treating hepatologists.

According to the manufacturers, unwanted side effects include a slightly laxative effect and rarely also allergic reactions.

I am sure you have been advised by your CF centre concerning measures to avoid unnecessary burdens on your child’s liver. It is most important in this context to pay attention to a good adjustment of the pancreatic enzyme substitution and thus also to a regular intake of enzymes, of course. Paracetamol, which is very popular, is to be strictly avoided if possible, as are drip solutions that contain alcohol. If there are any hints to an involvement of the liver in your child’s clinical picture, a compound containing ursodeoxycholic acid should be used.

To answer your question conclusively, I would like to make the following suggestion: since silymarin drugs are generally well tolerated, you should talk to your CF centre about your desire and, if applicable, use Legalon® by mutual consent. Getting a prescription for Legalon® will not be possible due to the limitation in usage.

Kind regards,
Dr. H.-G. Posselt