The US Food and Drug Administration (FDA) defines a generic drug as being “identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”
The FDA states that generic epilepsy drugs are just as beneficial as brand name drugs and there is no medical concern when substituting a generic medication for a brand name.
However, many doctors who specialize in treating patients with epilepsy have noted differences in those treated with generic medications compared to those treated with brand name ones.
What’s the Difference?
Epilepsy drugs are held to very high standards when it comes to their generic versions. They must have precisely the same amount of active ingredients as their brand-name versions. They must also meet the same level of standards when it comes to quality, purity and strength.
Generic drugs must also achieve almost exactly the same blood levels as brand-names (the main way that epilepsy medications treat seizures) with only a 3% or 4% difference. This is where many doctors believe the problem exists.
It is agreed that for most patients, there probably isn’t an issue between taking a generic or a brand name. But for some, they are already high risk and any change to their medication might impact seizure control. When they switch to a generic, the small percentage difference in blood levels could be enough to make their seizures worse.
Children may be especially vulnerable to the variances between generic and brand name anticonvulsants.
What’s the Problem?
If there is any doubt regarding the effectiveness of generic medication, then why are patients still taking it? Sometimes, it isn’t up to them or even their doctor.
Most doctors who treat epilepsy will tell you that they would never support a patient switching to a generic form of medication on their own. It should always be approved, and then closely monitored, by a medical professional.
However, some insurance companies automatically approve the generic instead of the brand name because of the FDA’s bioequivalence standard. If a patient requests the brand name, the costs can be unaffordable.
At the current time, the FDA is not willing to make any changes regarding their stand on generic anti-seizure medications. Without more research, more patients could be at risk of dangerous side effects from less than effective medication.
Until more is known about the differences between generic and brand-name anticonvulsants, be sure to speak in detail with your doctor regarding what treatment is best for you.
For many patients, using a generic medication is perfectly acceptable. But if you experience any changes after switching to a generic option, be sure to call your doctor immediately.