Lamisil, a medication used to treat nail fungus, should be monitored for side effects in children, according to a report by Food & Drug Administration (FDA) staff. According to the document, children treated with Lamisil have experienced a variety of side effects, including skin reactions, neurological problems, and psychiatric events. The FDA’s Pediatric Advisory Committee is scheduled to discuss the Lamisil side effect reports and make recommendations at a meeting today.
According to the FDA staff report, 47 postmarketing reports of adverse events associated with pediatric use of Lamisil were submitted to the FDA since approval through January 4, 2008. The majority of problems reported with pediatric use of Lamisil involved skin reactions. These included skin rashes (some with blisters) and a case each of erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), skin striae, hives, pruritus, and alopecia. The report noted that skin reactions, including SJS and TEN, are listed as potential side effects on the Lamisil label.
Seven cases of skin reactions occurred with oral Lamisil treatment, seven cases with topical therapy, and two cases received both oral and topical Lamisil therapy, the report said. Three cases required hospitalization (SJS, EM, and one case of rash with blisters and pustules)and one case of skin striae was considered to be disabling.
The FDA report also said that five cases of neurological side effects had been reported in relation to pediatric use of Lamisil. These events included seizures and shaking, headache and neck pain, mental impairment, walking difficulty, and somnolence. With the exception of headache, none of these side effects are mentioned on the Lamisil label.
The FDA also received three reports of psychiatric events, including suicidal thought, depression and self-harm. In all of the cases, the patients recovered after Lamisil treatment was stopped. In one case, a patient also had been diagnosed with Lyme Disease with “cerebral involvement” that could have contributed to symptoms.
Other pediatric patients treated with Lamisil experienced gastrointestinal events, musculoskeletal problems, renal and urinary symptoms, and hepatic events. Of all the pediatric side effects reported to the FDA, none resulted in deaths. However, six of 47 cases reported hospitalization, life-threatening, and/or disability outcome; these six cases included four cases of skin reactions, and one case each of leg pain and thrombocytopenia/anemia. The remaining 41 cases were considered serious because the reporter considered the event to be medically significant.
The FDA staff report recommends that reports of depression, suicidal ideation, and self-harm reported associated with Lamisil, across all ages, be investigated further. The FDA also said that staff would continue routine monitoring of all adverse events associated with pediatric use of Lamisil.
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