Inform patients before prescribing lamotrigine.

MIAMI BEACH -- Inadequate informed consent places physicians prescribing lamotrigine at increased risk of malpractice liability, Dr. Neelam Varshney suggested.

Given that, it is important to inform patients about the risk of a rare but life-threatening rash that can develop with lamotrigine, Dr. Varshney said in a poster presentation at the annual meeting of the American Academy of Psychiatry and the Law.

In an interview, Dr. Varshney pointed out that although such cases are rare, these rashes can progress to Stevens-Johnson syndrome or toxic epidermal necrolysis--which is fatal.

Severe rashes can result in hospitalization, permanent disability, or even death. "That is why it is so important to give adequate informed consent," said Dr. Varshney, a resident in the department of psychiatry at Elmhurst (N.Y.) Hospital. Also, it is important to remind patients of the risk throughout treatment. "Informed consent is not just given on the first visit," she said.

When prescribed as adjunctive therapy for epilepsy, the incidence of severe rash is approximately 0.8% among patients younger than 16 years and 0.3% among adults, according to a black box warning on the product's label. In clinical trials of adults with bipolar and other mood disorders, the rate of serious rash was 0.08% with monotherapy and 0.13% when used as adjunctive therapy.

In addition to issues surrounding informed consent, inadequate monitoring and wrongful diagnosis have been cited in lawsuits regarding lamotrigine.

Know the legal aspects for your own safety, Dr. Varshney advised. "It may not happen now, but it can be 10 years from now, and you get taken to court." She also advised ensuring that disclosures are documented in the medical record.

BY DAMIAN MCNAMARA

Miami Bureau