Children treated with the anti-fungal drug Lamisil have experienced side effects including skin reactions, neurological problems and psychiatric problems, according to a new report written by Food & Drug Administration (FDA) staff. The report recommends that Lamisil be be monitored for side effects in children. An FDA advisory panel is scheduled to take up the issue of Lamisil side effects 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. 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 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. 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 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.
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.
Other pediatric patients treated with Lamisil experienced gastrointestinal events, musculoskeletal problems, renal and urinary symptoms, and hepatic events.
