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Dangers of Substituting Generic Anticonvulsant Drugs to Treat Epilepsy

The American Academy of Neurology (AAN) opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending doctor's approval. Neurologists tend to oppose the switching of branded drugs with generics like Mylan generic Keppra unless it is medically indicated. Do you have an unsafe Mylan generic drug lawsuit?

To enter the market, a new generic drug must satisfy two requirements:

It is bio-equivalent* to the innovator drug.
It will not infringe any patents listed in the FDA Orange Book.

According to neurologists, subtle differences exist between branded medications and their generic equivalents which can result in toxic or subtherapeutic** levels. In the case of a patient with epilepsy, subtherapeutic levels can manifest into seizures, which are exactly what the medications are supposed to prevent.

Professional and patient support organizations around the world are concerned about patient safety with indiscriminate generic formulation substitution and have issued statements opposing replacement of prescription drugs without the physician's approval—in particular, stating that generic drug variability can be highly problematic for people with epilepsy.

According to a recent study, antiepileptic drugs (AEDs) have had a higher switchback rate from generics to branded medications than is seen with other classes of medications.

"Please do not forget that in switching back and forth from one medicine to another (whether it be from name brand to generic ... or from one name brand to another), it takes the average human body weeks, even months, to adjust. To expect to see those headaches and/or confusion disappear overnight is just not being realistic. I know that when I've changed drugs (or went to a generic), I didn't feel fully pleased until about two months afterwards. This is another -- You should be aware -- comment that even the best doctors often fail to make."

Have you or a family member suffered serious seizures after taking a Mylan generic drug for epilepsy? If the answer is yes, you may qualify for an unsafe Mylan generic drug lawsuit. There is no time like the present to talk to a lawyer to find out what your legal options are. Talk to us. We listen and advise. No strings attached.

* Bioequivalence is defined as, the property wherein two drugs with identical active ingredients or two different dosage forms of the same drug possess similar bioavailability and produce the same effect at the site of physiological activity (according to Merriam-Webster).

** Medication levels believed to be too low to be effective are called subtherapeutic levels.