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Nurse Questions Value of Generic Drugs

Q. I am a mid-level prescriber (a clinical nurse specialist) who has submitted 37 adverse event reports to the FDA’s MedWatch program regarding generic lamotrigine. Most of the adverse events involved a loss of response, but many involved a loss of response and additional side effects that did not occur with brand-name Lamictal.

The FDA has acknowledged receiving my reports, but it has not investigated them. When a generic for Lamictal first came on the market, I was enthusiastic, since I knew my patients would be paying less. But after so many patients had serious relapses of their mood disorders or other bad experiences with several generic lamotrigine formulations, I am no longer enthusiastic.

I believe that the generic equivalents of Lamictal differ markedly in bio-equivalence, enough so that they may actually cause harm to patients. I worry that the problems with generics are more pervasive than we are willing to admit.

A. We too have received complaints about the generic form of Lamictal (lamotrigine). This anti-seizure drug is also prescribed for bipolar disorder.

Here is just one example: “Has anyone else had problems with generic Lamictal? I have taken this for years for bipolar disorder with great results. In the last few months I have had a couple of terrible depressive episodes and thoughts of suicide. I wondered if the meds had just stopped working. Then I realized I was switched to the generic a couple of months ago.”

Others have reported problems with another generic epilepsy medicine, levetiracetam (brand name is Keppra). Anyone who wishes to read about generic drug problems can do so at www.peoplespharmacy.com.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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