Suicide Warning on Epilepsy Drugs Intensifies Clinical Responsibility

December 16, 2009

December 16, 2009 (Boston, Massachusetts) — New warnings on antiepileptic drugs will have important medical-legal implications for clinicians. This was the sobering news specialists heard here at the American Epilepsy Society 63rd Annual Scientific Conference.

It was this time last year that the US Food and Drug Administration (FDA) instructed all manufacturers of antiepileptic drugs to include a warning indicating an increased risk of suicide. The warning clearly and unambiguously states the need to screen for psychiatric disorders associated with suicide. One year later, there is confusion about where this responsibility lies, and not all patients are being monitored. It is a gap that specialists say could leave clinicians at risk in a court of law.

"Neurologists must monitor patients for the emergence of any symptoms and document this activity in charts," Andres Kanner, MD, from Rush University Medical Center in Chicago, Illinois, said during an interview."We cannot afford to be lackadaisical."

Dr. Kanner expressed frustration about this issue. He is coordinator of a psychiatry special interest group for the epilepsy society and says that he will adhere to the FDA warning even though he does not agree with it.

"We reviewed the data from the FDA and do not agree with the conclusions of the meta-analysis," he told Medscape Neurology. "We do not support the inclusion of all antiepileptic drugs." Dr. Kanner's group has raised these and other concerns to the agency and plans to continue these efforts.

But agree or not, William Mandell, a lawyer specializing in health law, warned that the regulatory decision has important legal implications. "I think it would be dangerous to take false comfort in the notion the advisory is based on faulty science," he said.

"The FDA has the authority to make these decisions and the warning is clear," Mr. Mandell noted. "Any decision not to screen patients treated with antiepileptic drugs for depression, suicidal thoughts or behavior, and unusual changes in mood could open you up to potential liability."

Curt LaFrance, John Barry speaking at the meeting, Alan Ettinger, and William Mandell.

Legal Implications

Mr. Mandell emphasized the importance of awareness and vigilance among prescribing physicians. "You are accountable and must respect the FDA warning," he said.

But neurologists monitoring for psychiatric disorders? The resistance in the room was palpable. One by one, attendees took the microphone to raise concerns about clinicians working outside their area of expertise, having to add more items to an endless checklist, and using nonspecific or nonvalidated screening approaches.

Rochelle Caplan, MD, from the University of California, Los Angeles, said the era where neurologists did not need to ask about psychiatric well-being is over. Dr. Caplan is a pediatric neuropsychiatrist and speaker at the meeting. She says the medical community has a responsibility to patients and must work together to address these issues.

Regularly evaluating a group of patients we already know are at increased risk will improve quality of care.

David Dunn, MD, from Indiana University at Indianapolis, said that clinicians should be asking about suicide as a standard question.

John Barry, MD, from Stanford University in California, said he agrees and pointed out that screening tools can be beneficial and efficient.

Although meeting attendees debated whether antiepileptic drugs heighten suicide risk, there was 1 point everyone in the room seemed to agree on: patients with epilepsy are at increased risk of suicide.

"Regularly evaluating a group of patients we already know are at increased risk will improve quality of care," Dr. Caplan said.

At the end of the day, Mr. Mandell added, "A good relationship with patients and their families is the best risk management. We need common sense and a humane approach."

The speakers did not discuss their financial relationships at this special interest group meeting.

American Epilepsy Society (AES) 63rd Annual Scientific Conference: Psychiatry Special Interest Group Meeting. December 8, 2009.


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