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 presented 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 to toxic epidermal necrolysis.
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.
It is a good idea to have solid therapeutic rapport for explaining everything to the patient, including risks and benefits. Also, it is important to remind patients of the risk throughout treatment. “Informed consent is not just given on the first visit,” she said.
Some physicians have suggested showing pictures of the rash to patients, but Dr. Varshney said she thinks doing this is unnecessary.
When prescribed as adjunctive therapy for epilepsy, the incidence of severe rash is about 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.