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

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WebMD Feature

The FDA says generic epilepsy drugs are no different from generic drugs for other conditions: virtually identical to brand-name drugs in their effects. Therefore, there's no problem substituting generic drugs for epilepsy.

But many doctors who specialize in treating epilepsy don't agree. For a small minority of patients, they say, generic drugs may be less effective at controlling seizures. Disturbed by seeing people develop seizures soon after changing to generic drugs, many epilepsy doctors are questioning the FDA's position.

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Understanding Epilepsy -- Symptoms

 Seizures are the basic indicator of epilepsy. They vary widely: Staring straight ahead, repetitive swallowing, and lapsing into complete immobility for a few seconds characterize absence (petit mal) seizures, which can recur many times in a day. Tonic/clonic (grand mal) seizures, which usually last several minutes, typically begin with a loss of consciousness and a fall, followed by rigidity, then jerking motions and incontinence of urine. After the seizure ends, there is usually a period...

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"There are enough anecdotes to be of concern," says Shlomo Shinnar, MD, spokesman for the American Academy of Neurology. "Until we're sure there's no problem, no substitutions should occur without a decision by the patient and the physician."

But sometimes that's not as easy as it sounds. For instance, to cut costs, some insurance companies may automatically convert some prescriptions from brand to generic epilepsy drugs at the pharmacy. Or the price difference between brands and generics is so large, people with epilepsy are effectively forced into a switch to generic drugs.

The standoff pits insurance companies, health plans, and pharmacies against doctors and people living with epilepsy. Although experts believe relatively few people with epilepsy are vulnerable, "for some of them, a new seizure can be a threat to their livelihood, or even their life," says Shinnar.

Generic Epilepsy Drugs: Does a Problem Exist?

The FDA tightly regulates manufacture of all generic drugs, just like brand-name drugs. Epilepsy drugs are held to the same high standards:

  • Generic epilepsy drugs have precisely the same amount of drug as the brand-name version.
  • Generic drugs must meet the same high standards for purity, quality, and strength as the drugs they imitate.
  • In reviews done by the FDA, generic drugs achieve almost exactly the blood levels as brand-names -- with only a 3% to 4% difference.

With generic and brand-name epilepsy drugs so similar, how could there be a problem with generic drugs? Experts believe that whatever problem with generic drugs exists, it doesn't affect most people with epilepsy.

"For the vast majority of patients, there probably isn't a problem with switching to a generic," says Jacqueline French, MD, professor of neurology at New York University's school of medicine. "But some people are on relatively thin ice when it comes to seizure control. They're sensitive to small changes in blood levels" of their epilepsy drugs, she says.

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