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Epilepsy Treatments: Keeping Seizures Under Control

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Epilepsy Medications: When Is It Safe to Substitute a Generic?


Potential Problems With Generic Epilepsy Drugs continued...

"Yes, I think there's a real problem, although we don't know the magnitude of it right now," says Steven Schachter, MD, professor of neurology at Harvard Medical School. "I think we all need to use caution with generic substitution until all the facts are in."

Almost 90% of physicians recently surveyed agree a problem exists, according to a leading epilepsy journal. Further, two-thirds of doctors treating epilepsy linked new seizures in their own patients with a switch to generic drugs.

Responding to its members' concerns, the American Academy of Neurology issued a position statement in 2007 speaking out against forced switching to generic drugs for epilepsy. Leading epilepsy advocacy groups take the same stance.

No Evidence, No Action, Says FDA

So far, the controversy has not spurred the FDA to make a change. Citing the lack of good evidence to the contrary, FDA's position remains that generic epilepsy drugs are, for all intents and purposes, identical to their branded counterparts. Generic substitution, even monthly, shouldn't cause breakthrough seizures or other side effects.

Officials suggest that seizures don't really increase after a switch to generic drugs; rather, they say doctors and patients are more likely to recognize seizures during this time, and wrongly blame the generic epilepsy drug. Lacking good data either way, the FDA encourages doctors to report problems related to switching to generic drugs to its web site.

Switching Epilepsy Drugs Has Hidden Costs

Leading neurologists say the attempts to cut costs by insurance companies that force patients to switch epilepsy drugs are misguided and counterproductive.

"Seizures are expensive," says Orrin Devinsky, MD, professor of neurology at New York University's school of medicine. "If someone's been controlled, having just one new seizure has huge costs, in employability, driving, their whole life," he adds. "That's not even to mention the possibility of injury, even death."

On a practical level, patients switching to generic epilepsy drugs also need increased blood level checks and more frequent doctor's visits, reducing any cost savings from the generic drug, according to French.

The controversy won't go away any time soon; the friction is only likely to grow. The American Academy of Neurology recommends doctors use newer, expensive branded medicines as first-line treatment for new cases of epilepsy. Many more branded epilepsy drugs will go generic in the next few years. And insurance companies and health plans will always seek the lowest drug costs.

Studies are planned to try to settle the issue. So far, though, studies are stuck on the drawing board. One of the obstacles, French says, is finding people willing to gamble for the sake of science. She asks: "Who's going to sign up when they might get a generic in place of the brand-name drug that's controlling their seizures now?"

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Reviewed on October 28, 2009
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