Epilepsy: What the Future Holds

by Food and Drug Administration (FDA)

(Page 3 of 3)

Van Hazerbeke says The Epilepsy Foundation is excited about efforts in the area of genetic research.

"It is very likely that we will find that a lot of epilepsy has a genetic basis — not necessarily that a person has inherited it but that within their physiology there has been a new mutation," he explains. "In July 1998 the British journal Nature published an article based on finding a gene in a mouse model for a common form of epilepsy, absence or petit mal epilepsy. It's called the stargazer gene — after the mouse's name, Stargazer — and the study is considered a breakthrough."

Van Hazerbeke says the new study may lead to a test to determine if an individual has a particular form of epilepsy and that may eventually lead to reversal, prevention, or a cure.

Approximately 150,000 new cases of epilepsy are diagnosed annually. Although few people actually die during seizures, the sheer numbers of people battling the disorder, the high costs associated with the condition, and lifestyle limitations make advocates determined to keep looking for answers.

"The biggest problem is that epilepsy is still considered [by some] to be a condition involved with mental illness or demonic possession," says DeLorenzo. Although things are better today, he explains, many epilepsy sufferers still feel stigmatized by their condition. He adds that a big misconception about epilepsy is that the general public feels it's a simple, easy-to-control problem instead of a complex disorder.

Although many experts say full or partial control of epileptic seizures can be achieved via modern treatment methods in 85 percent of cases, DeLorenzo estimates that only about half of all people with epilepsy are well-controlled.

"This represents a major public health problem that needs to be addressed. Well-controlled patients can lead a normal life," he emphasizes.

DeLorenzo is developing a database of epilepsy patients at MCV Hospitals to help develop drug protocols. In addition, under an NIH grant, DeLorenzo has determined that in several animal models the ability to develop epilepsy is calcium-related.

"If this is also true for humans, drugs can be developed to block this [effect]," he explains.

FDA's Katz notes there are currently a number of epilepsy drugs in development and there is a great deal of research on the basic mechanisms of the disorder.

"That's good," he says, "because the better you understand an illness, the more likely you are to create treatments that are effective in treatment and prevention."

If you're present when someone has a seizure, keep calm and help the person to the floor, loosening any clothing around the neck. Remove any sharp objects that could cause injury and turn the person on one side so saliva can flow from the mouth. Putting a cushion or a folded coat under the head for a pillow is fine, but don't put anything in the person's mouth.

Some people will sleep or want to rest following a seizure; they may be confused and need help getting home. Obviously parents should be contacted if a child has a seizure.

If you know that the person having a seizure has epilepsy, an ambulance is probably unnecessary unless the seizure is prolonged (more than five minutes). If you don't know, or if the person is diabetic, ill or pregnant, get help immediately.

Strict Warnings for Felbatol

The drug Felbatol (felbamate) caused much excitement when it was first approved in 1993, says Russell Katz, M.D., deputy director of FDA's division of neuropharmacological drug products. But a year later, reported cases of bone marrow suppression and liver problems caused FDA to take quick action.

"Felbamate was approved for use as an add-on drug or in monotherapy, and prior to approval it seemed to have few significant side effects. People began to use it quite a bit," Katz recalls.

After the drug had been on the market a year, FDA began to receive reports that patients were developing aplastic anemia, a potentially life-threatening disorder in which the bone marrow essentially shuts down and stops making blood cells. Some of the users required bone marrow transplants, and there were some deaths.

"We had seen nothing prior to approval indicating this drug would do this," Katz says. "We had a very serious side effect. There was a low incidence rate, in terms of overall numbers, but here's the problem: say 1 in 5,000 people taking a drug gets an adverse [reaction]. For the typical physician, that is a low rate; he or she may not have a patient that experiences that [reaction]. But if 1 million people are taking the drug and 1 in 5,000 have adverse effects, that is a lot of cases from the public health perspective."

FDA met with its advisory committee, an outside review panel of experts, and the decision was made to keep felbamate on the market but in a severely restricted capacity.

"The professional labeling has huge warnings on it that say felbamate is not indicated as a first-line epileptic treatment; it's only for those whose epilepsy is so severe that a substantial risk of aplastic anemia or liver failure is deemed acceptable in light of the benefits conferred by its use," Katz explains. "The patient package insert includes an information consent form in bold letters because now the company requires doctors to get informed consent from patients to use it, which is very unusual. Because it is a potentially extremely dangerous drug, usage has gone down considerably as a result."

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