Given the increases in costs of prescription drugs over the years, it’s not uncommon for doctors, pharmacists and insurers to switch patients to the generic form of prescribed drugs in an effort to help patients save money. Sometimes this practice is safe and helpful to consumers. Studies have shown, however, that it’s not safe to make substitutions from brand name to generic drugs and vice versa when dealing with anti-epileptic drug, (AEDs). In fact, when it comes to AEDs, substitutions can cause breakthrough seizures, serious injury, or even death.
Typically, manufacturers of generic prescription drugs must show that their product is the “bioequivalent” of the brand name drug. However, “bioequivalent” does not mean that the drug is the same. The generic may contain the same level of active ingredient as the brand name drug, but the FDA allows for some variance in the inactive ingredients as long as the variance and the resulting effect on the body is not deemed significant. According to the Epilepsy Foundation, substitutions of AEDs, either from brand name varieties to generic, or from generic to brand name, can be dangerous because studies show that even a slight variation in the amount or delivery of the active ingredient can lead to serious injury or death in epileptic patients. A patient’s epilepsy medication may be substituted by doctors who are unaware of the potential side effects of making the change, pharmacists who may unilaterally decide to fill the prescription with the generic instead of filling it as written, or by health insurers who require that the patient only receive the generic form as a cost-cutting measure. In a three-year survey of patients who switched from brand-name to generic AEDs, 59% of the respondents experienced worse seizures and 49% experienced worse side effects.
Keppra is the brand name for an anti-epileptic drug that went off patent in January 2009. After this date, the generic form of the drug, Levetiracetam, began being substituted for Keppra. The Epilepsy Foundation as well as the American Academy of Neurology strongly oppose generic substitution of AEDs and are fighting to bring this issue to the attention of doctors, patients, health insurers, the FDA and Congress. If you have experienced adverse effects of being given a generic substitution for Keppra, please contact Roger Smith or Danielle Mason at 800-898-2034 or by email at Roger.Smith@beasleyallen.com or Danielle.Mason@beasleyallen.com for more information.
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