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Published: Friday, 7/11/2008

'Black box' warnings on epilepsy drugs nixed


WASHINGTON - Drugs used to treat epileptic seizures can raise suicide risks, but not enough to warrant the strongest warning labels available, a government panel of experts said yesterday.

Advisers to the Food and Drug Administration voted 14-4 against adding a "black box" warning about the risks of suicidal tendencies to all anti-seizure drugs. The experts said they worried the warning labels inadvertently could cause doctors and patients to abandon the treatments.

"If we have good drugs that are working, we have to be very careful about scaring patients into not taking them," said Rochelle Caplan, a professor of psychiatry at University of California, Los Angeles.

The FDA announced plans this week to add boxed warnings to epilepsy drugs, in light of higher rates of suicidal tendencies seen across dozens of studies.

The panel vote against that plan makes it less likely that blockbuster drugs from GlaxoSmithKline, Pfizer Inc., Merck & Co. Inc., and others will carry the FDA's sternest warning.

Instead of a boxed warning, a majority of panelists said companies should distribute pamphlets about the drugs' risks to patients.

The agency often follows its panels' advice, though it is not required to do so.

FDA officials said they would decide what course to take "soon," but would not specify a time line.

If regulators abandon the proposed warnings, it could protect U.S. sales of seizure drugs, which grew to over $10 billion last year, according to pharmaceutical research firm IMS Health.

The agency announced earlier this year that patients taking 11 widely used anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking dummy pills.

In a separate vote, panelists unanimously backed the FDA's findings on those drugs, which included GlaxoSmithKline's Lamictal, Merck's Topamax, and Pfizer's Lyrica.

More than 10 million Americans take the anti-seizure medications, which are also used to treat migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.

Pfizer Vice President Steven Romano said he was pleased with the panel's vote against a boxed warning label.

Physician groups told panelists that patients experiencing seizures are already at risk for depression, making it difficult to tell whether drugs aggravate those problems. "Why put a black-box warning on when you're not yet sure of the impact these drugs have?"Jacqueline French of the American Psychiatric Association said.

Panelists weighed the backlash over past FDA black-box warnings in decidng not to back bold labeling about suicide.

The FDA came under fire in 2004 over a black-box warning about suicide risks seen in children and adolescents taking antidepressants. Regulators softened the language last year after psychiatrists charged that it was discouraging doctors from prescribing the drugs, putting patients at greater risk of suicide.

But FDA scientists said fewer prescriptions for depression treatments like Wyeth's Effexor are not necessarily a problem.

"It's not yet clear whether or not the black box has had any effect on what we care about most, which is suicide," said Thomas Laughren, FDA director of psychiatry products. "We do know prescribing is down somewhat, but that could be a good thing or a bad thing."

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