The U.S. Food and Drug Administration wants an updated label for Amgen Inc.'s Enebrel to include warnings that the rheumatoid arthritis drug can be deadly when taken by children, and that the drug can cause serious infections in adults, the Wall Street Journal reported Monday.
In documents posted on its Web site, the FDA said infections, malignancies and neurological problems have been reported among children who have used the drug. These problems are similar to those experienced by some adults, the newspaper reported.
Enebrel is used to treat RA in adults and children and the skin disorder psoriasis in adults. While the drug's use in children is thought to be limited, the FDA said the number of life-threatening pediatric reactions disclosed to the agency's adverse event reporting database was "concerning," the Journal said.
Amgen has applied to the FDA to expand Enebrel's approved usage to include treating children with moderate-to-severe psoriasis. An expert panel advising the agency is set to consider whether to recommend the application when it meets Wednesday, the newspaper said. The full agency isn't bound to follow the suggestions of its advisory panels, but usually does.
"Given these considerable risks associated with [Enebrel], the benefit of this therapy in children with plaque psoriasis would need to be substantial in order to justify its approval and usage in the pediatric plaque psoriasis population," the agency said.