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
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
"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
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?"