FDA Memo Cites Serious Health Problems in Children Given Lamisil

Hospitalizations, and Neurological Problems Reported

Lamisil, an antifungal medication known generically as terbinafine, has been associated with 47 instances of serious adverse events in children as of January 4, 2008, according to a memorandum from the Food and Drug Administration (FDA).

Of the 47 cases, 6 involved hospitalization, life threatening or disabling outcomes, specifically, 4 cases of skin reactions, 1 case of thrombocytopenia, and 1 instance of leg pain. The FDA memorandum notes that "the remaining 41 cases were considered serious because the reporter considered the event to be medically significant."

The report also lists reports of seizure, mental impairment, walking difficulty, and sleepiness, as well as 3 psychiatric events including depression/suicidal ideation, and self harm, which the FDA states "may warrant further investigation."

Lamisil is used to treat fungal infections in children and adults. It is currently available as topical or oral medication, and as of September 28, 2007 as oral granules for fungal hair infections in children 4 years and older. The drug was approved for use in children in December 2006, based on data from two 6-week randomized controlled studies.

NOV-18-2008: FDA Cites Serious Adverse Events In Children Given Lamasil [FDA: TERBINAFINE ADVERSE EVENTS]

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Published on Nov-18-08