FDA staff recommends liver warning on Merck's Cancidas
WASHINGTON |
WASHINGTON Dec 4 (Reuters) - U.S. Food and Drug Administration staff reported on Friday they will recommend labeling changes for Merck's (MRK.N) Cancidas (caspofungin) to warn of possible problems related to liver function when the drug is given to children.
The recommendation is contained in briefing materials to be considered by the FDA's Pediatric Advisory Committee meeting on Dec. 8.
The FDA staff said their review of reported adverse events showed that in seriously ill children there were some cases of increased liver function and of liver injury.
They said they found no other safety issues that warranted any label changes for the drug.
Cancidas is used to treat fungal infections involving intra-abdominal abscesses, peritonitis and pleural space infections, as well as esophageal candidiasis.
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