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COPYRIGHT 2003 International Medical News Group
GAITHERSBURG, MD. -- Topical calcineurin inhibitors' labeling needs to be changed to include a box warning reiterating that these agents should not be used in children younger than 2 years, according to a Food and Drug Administration advisory panel.
The impressive safety margin of the calcineurin inhibitors (CIs) was the compelling reason behind their approval by the FDA in the first place, Dr. Jonathan Wilkin told the pediatric advisory subcommittee of the Anti-Infective Drugs Advisory Committee. But concern about the possible cumulative effects of the drugs on development of growing children prompted the FDA to make the CIs second-line therapies, said Dr. Wilkin, director of...
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