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
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But the ketogenic diet is real and legitimate. It works very well in many people. The catch is that it's extremely demanding and difficult to follow. In fact, it is so difficult to follow that most doctors recommend it only for people who haven't been able to control their seizures with ...
"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
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
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.
Potential Problems With Generic Epilepsy Drugs
There may be several ways switching to generic epilepsy drugs could cause
potential problems, experts say. Many epilepsy drugs are absorbed and
metabolized in more complex ways than other drugs. Researchers argue that
although the differences in generics allowed by the FDA do not affect treatment
for most conditions, the differences could have a negative impact for treating