THE VIRGINIAN-PILOT
Copyright (c) 1994, Landmark Communications, Inc.
DATE: Friday, August 19, 1994 TAG: 9408190606
SECTION: LOCAL PAGE: B1 EDITION: FINAL
SOURCE: BY DIANE TENNANT, STAFF WRITER
LENGTH: Medium: 99 lines
A life-and-death question faces thousands of parents whose children have epilepsy: whether to continue or stop an anti-seizure drug that may cause a fatal form of anemia.
Mark Campbell and Julie Jackson both chose life for their children - Campbell by leaving his son on felbamate, Jackson by taking her son off the drug. Both Virginia Beach families agonize over the choice, as do thousands of Americans whose doctors have been advised by the drug manufacturer and the Food and Drug Administration to stop treating their patients with felbamate.
Life, Campbell said, has never been the same since 9-year-old Chris started taking felbamate last September. Where other anti-seizure drugs left his son lethargic and drowsy, felbamate has enabled him to do activities like swimming, biking and running.
``I don't want him to be anything but what he can be,'' Campbell said. ``I don't want him to be less. It's something to see a child go from a zombie state to where he's doing for himself.
``He can run. He can run. I couldn't take that away from him.''
The manufacturer and the FDA have urged that doctors and parents stop giving felbamate in most cases. Less than a year after it was released by Carter-Wallace Inc. as Felbatol, felbamate was linked to 10 cases of aplastic anemia, a frequently fatal disease in which the bone marrow quits making blood cells. Two people died. The manufac turer wrote to doctors, urging them to stop using the drug. Since then, two more people have died, and known cases of aplastic anemia in felbamate users have risen to 21. That is at least 50 times the expected rate, according to the manufacturer.
``It was originally felt that the benefit (of the drug) certainly outweighed the risks,'' said Mike Schaffer, an FDA spokesman. ``With these findings, it certainly puts that in question.''
During clinical trials, 2,000 patients took the drug without developing aplastic anemia. But the disease is so rare that it did not appear as a side effect until hundreds of thousands of people were using the drug, the FDA said.
The manufacturer has not withdrawn the drug from the market, because it is highly effective in controlling seizures. Patients who choose to stop using it must phase it out under a doctor's supervision, because abrupt withdrawal may actually trigger seizures.
Local neurologists have been swamped with calls from worried patients since news reports of the felbamate-anemia link began. The Jackson and Campbell families were among them.
``We were really afraid, we've got to get him off it, but what's it going to do to him?'' Jackson said. ``Before the Felbatol, he was having anywhere from six to eight seizures a month. Once he started on this medication, his seizures went down to three or four a month, which is a big difference.''
Jackson's son, David, is 8 years old. No medication could control his seizures, until felbamate came along last September, the first new anti-seizure drug in 15 years. Felbamate cut not only the number of David's seizures, but the length as well, from an hour to two minutes.
David's neurologist, Dr. L. Matthew Frank, has been seeing patients in the evenings and through lunch in an effort to reach everyone who is on felbamate, said Kristi Johnson, a registered nurse in his office.
``As we speak, I am going through 4,000 charts, one by one, chart by chart, just to make sure we catch everybody,'' she said. ``It's been hectic.''
Nearly all of Frank's patients who were using felbamate have chosen to stop, she said. The Campbells are an exception.
Felbamate has done such wonders for Chris that his parents refuse to take away his new-found abilities.
``It's given him a freedom he never had,'' said Tammy Campbell, his mother. ``Before, he felt so restricted because he couldn't do things, but now he can.''
Two days after Chris began taking felbamate in September 1993, he could ride a bicycle, she said. That skill had eluded him for years. ``My husband and I just stood in the driveway crying, because we could not believe it,'' she said.
The Campbells worry about felbamate, but feel reassured that most cases of aplastic anemia appeared within six months of beginning the drug. Chris has been on it for nearly a year. They also suspect that felbamate alone is not the culprit, that perhaps a combination of things leads to the disease.
Johnson said all parents agonize over the decision to use or to stop felbamate. The drug has helped control seizures where others had failed, she said, and taking that away from a child is hard for parents.
``It's a tough decision for some of these kids who just have so many seizures,'' Johnson said. ``When you can see light at the end of the tunnel, then you turn that light off, it's rough.'' ILLUSTRATION: Color photo
PAUL AIKEN/Staff
Chris Campbell, 9, has epilepsy. His parents are keeping him on
felbamate because of its benefits.
Color photo
IAN MARTIN/Staff
Julie Jackson has taken her son, David, 8, off the anti-seizure drug
felbamate. The medication has been linked to cases of aplastic
anemia, a frequently fatal disease.
by CNB