Lamisil, itraconazole may cause liver failure in susceptible patients

A number of reports on adverse effects of Lamisil therapy have been reviewed over the years by the FDA in USA and other organizations alike all over the world.

Lamisil prescribed for the treatment of tinea capitis (scalp ringworm)

The advise which was given to medical professionals all over the world on the matter was to thoroughly check the diagnosis before administering Lamisil or itraconazole. Thorough checking would include obtaining a sample of the affected tissues and testing them in the laboratory for fungal infections. The health care professionals should avoid needlessly risking the patients health when the diagnosis such as onychomycosis has not been confirmed by the tests.

The agency took action after reviewing 24 cases of liver failure possibly associated with itraconazole therapy and 16 cases of liver failure possibly linked to oral Lamisil therapy. Some of these patients did not have liver disease before starting systemic antifungal therapy. Both reviews included 11 reported deaths. About half of the cases of liver failure associated with itraconazole therapy involved patients taking the drug for a fungal nail infection or other dermatological infection.

The new labeling for both products advises clinicians to ask their patients to report any symptom of hepatic dysfunction, such as nausea, anorexia, unusual fatigue, vomiting, jaundice, dark urine, or pale stools. Patients who will be taking itraconazole should be told to report any sign or symptom of CHF. The labeling for itraconazole does not provide examples of CHF signs and symptoms for clinicians to use in communicating with patients, but FDA offered the following patient-friendly list: shortness of breath; swelling of the feet, ankles, legs, or abdomen; weight gain; unusual tiredness; coughing up of white or pink mucous, and a sensation of unusually fast heartbeats.

Although the above warnings have been issued the FDA has approved the drug in treatment of tinea capitis (scalp ringworm) for children aged 4 or more.

According to the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to get pharmaceutical companies interested in conducting pediatric studies to develop clinical information that lead to safe and effective formulations, studies and dosing for pediatric populations. The FDA will only grant a drug pediatric exclusivity if that drug meets detailed requirements. The FDA makes a request, in writing to the manufacturer. The manufacturer can encourage the FDA to make a written request for pediatric studies.