Epilepsy Medications: When Is It Safe to Substitute a Generic?
Potential Problems With Generic Epilepsy Drugs continued...
For instance, in one study, volunteers took brand-name Dilantin or the
generic version of Dilantin, which is phenytoin. Those taking generic phenytoin
had average drug levels that were 13% lower over time than in those taking
brand-name Dilantin. Computer simulations predicted that over time, half of
those taking generic phenytoin would have blood levels too low to prevent
To be sure of their equivalence with brand names, generic drugs are tested
only in healthy adults. In real life, people taking epilepsy drugs often have
multiple medical problems and take other medications, which could lead to
- The FDA acknowledges that because a large number of manufacturers make
generic drugs, the chance exists that a limited number of epilepsy drugs not
truly equivalent to brand-names could reach the market.
- Generics aren't tested against each other; each is tested only against the
brand name. "One could be slightly lower than the brand, and another slightly
higher," says French. "They both meet quality standards, but they could be
significantly different from each other."
The variance between generic drugs is a likely cause of any problem that
exists, according to French. She believes the biggest problem lies not in the
initial switch, but in repeated switching between generic epilepsy drugs made
by different manufacturers.
Because generic drugs are often made by multiple manufacturers, says French,
"some people are being switched from generic to generic every month. Even if
there's a small variation between each generic form, you have no idea what's
happening with the person's blood levels."
She's even seen a patient who had a bottle of generic pills with half from
one manufacturer and the other half from another manufacturer, when the
pharmacy changed suppliers after running out while filling the
Experts are quick to concede that their collective stories and experience
"are cause for concern, but it's not evidence," according to Alan Ettinger, MD,
professor of clinical neurology at the Albert Einstein College of Medicine.
"What's needed are well-designed clinical trials to settle the issue."
Studies on switching of epilepsy drugs have so far been limited, but they,
too, hint at a possible problem.
- In a Canadian study from 2007, more than one-quarter of people switching to
generic Lamictal switched back to the brand-name drug within three years.
People taking generics averaged one more visit to the doctor each year. And
among people who were hospitalized, those taking generic epilepsy drugs stayed
in the hospital slightly longer.
- In a 2008 study of people with breakthrough seizures after a switch to
generic drugs, blood levels of epilepsy drugs were compared before and after
the switch. Half the people with seizures had lower blood levels of the generic
But many doctors treating epilepsy today are unwilling to wait years for
clinical trials to provide answers. Based on lab studies and their own
experience managing epilepsy, they're raising a caution flag over switching to