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Generics Compared Against Each Other, No Difference Found

Generics Compared Against Each Other, No Difference Found

Study confirms no detectable difference when switching between generics

GenericVSWhile approved generics are required to be equivalent to their brand-named counterparts in terms of active ingredients, some may wonder if a switch between generics could cause problems for someone who relies on daily medication to control a severe, chronic condition, like seizures.

A new study led by Michael Privitera, MD, professor of the Department of Neurology and director of the Epilepsy Center at the University of Cincinnati Neuroscience Institute, tested two generic lamotrigine (prescription antiepileptic) products and found no detectable difference in clinical effects among patients in the trial. The findings were published this week in an advance online edition of The Lancet Neurology.

“Study results show that as long as patients adhere to their treatments, the two generics did not show any difference in their bioequivalence,” says Privitera. “Consequently, it should give increased confidence to both clinicians and patients that existing regulations are providing generic drugs that can be safely substituted, even in cases where medicine is life-saving. Patients can now feel safe about substituting generics (of their antiepileptic drug) without concerns of interactions or undesired effects.”

The study included 35 patients, adults with epilepsy who currently take lamotrigine, and looked at long-term dosing using two currently on-market epileptic generic drugs. The researchers took measures to ensure treatment adherence, a factor that can affect long-term trials. This trial used patient diaries, electronic medication monitoring and tablet counts to keep adherence to nearly 100 percent.

This study was initiated after several previous uncontrolled studies suggested risks with generic switching, but other studies showed no such risk. The American Epilepsy Society (AES) expressed concern over reported differences in antiepileptic generics. AES, the American Academy of Neurology and other professional societies had opposed patients substituting antiepileptic generics for people with epilepsy without consent of the physician or patient out of concern that the U.S. Food and Drug Administration (FDA) was allowing room for too much variability across formulations.

The need for effective generics is essential to some patients who need daily medication to treat serious conditions like epilepsy. The FDA estimates $230 billion per year is saved by generic substitutions.

The FDA, who had not tested generic-to-generic, agreed to fund three studies with AES and the Epilepsy Foundation (EF) as co-funders—referred to as EQUIGEN. This trial used two generics considered the most disparate products on the market, and in a double-blind study, switched patients from one generic to the others throughout the course of the trial.

Lamotrigine, a widely used drug for the treatment of epilepsy, is an ideal drug for this assessment, says Privitera, particularly because it has also been the subject of the noted problems with generic switches and complaints to the FDA. Additionally, it is considered a more sensitive drug, susceptible to drug-to-drug interactions.

With these new findings, a variety of factors could explain the cause for the previously reported inconsistencies, says Privitera. “One is the ‘nocebo’ effect, where patients and clinicians expect the generic products to be inferior, so the therapeutic effect is assumed to be reduced.”

Other issues that led to concern over generic switching could be attributed to pill confusion—because every time a patient switches generics, the pill color or shape will change—or that the quality of generics are improving over time, says Privitera.

The study was developed through collaborative efforts of the authors, the FDA and several organizations holding widely differing views on generic safety, designed to address skepticism surrounding generic antiepileptic drug treatments, and clear up several criticisms of the standard generic drug approval process. While the study is limited to a drug used extensively in epilepsy and psychiatry, the implications of such findings extend beyond this particular drug, indicating that FDA standards for bioequivalence are appropriate.

To further confirm the findings in this study, a single-dose study of the same generic lamotrigine products is currently underway.

Source:

University of Cincinnati (UC) Academic Health Center

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16 Comments

  1. Who funded this study? Seems it was the drug company people are making complaints about, yes? If so, not worth reporting this. C’mon. And only 35 patients in this study….35?! Did they also have these patients on 1 generic and switch the generic (the inert ingredients) after their bodies got used to the formula?! Pretty irresponsible report actually. I know many patients who are triggered because they are very susceptible to drug companies obtaining generics from diff sources mid-script which alters much in the ‘expectation’ of the body.

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  2. I am more concerned regarding switching from name brand to generic..I have read studies that indicates an increase in seizures in patients who were controlled on name brand but had break through seizures when switched to generics

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  3. My son HAS to have 2 name brand meds or he has breakthrough seizures. Thank goodness his neuro agrees and fights the insurance company. Whomever did this study OBVIOUSLY has not had to watch their child have seizures!

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  4. My daughter doesn’t have good seizure control with generics. I thought it was interesting that florida Medicaid will only cover brand in rescue Diastat. Makes you wonder??

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  5. My son has never had problems with generic.

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  6. Cathy Staeven. This his is so not true. Seizures medications coming from different drug companies can cause break through seizures because the strength of these medications differ. They can be a little stronger in strength or a little less. If you must be on a generic seizure medication (because of insurance reasons), and most of us are, then this generic medication Must come from the same drug company to prevent break through seizures. I don’t know how this study was ever able to have been confirmed.

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  7. We have had issues with the performance of generic Trileptal. It seems to absorb quicker, slam her system with dizziness and then break through seizures when it levels out.

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  8. My daughter had daily break thru seizures with generic Keppra and does significantly better on name brand, even though the generic is made by the same company. It just didn’t work.

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  9. My son had less control with generic.

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  10. Im on generic of Zonegran(Zonisamide). Tried fighting with insurance company for years but thankfully no problems on generic.

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  11. This study is insane. My son is on name brand due to a special diet. And name brand you can get all info such as carbs, sugars in them. (For ketogenic diet purposes). Generic are more vague and can have different fillers. I don’t agree with this study at all. Maybe pharm company’s shouldn’t “rape” ins company’s & make people lives more difficult when all people want to do is be seizure free!

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  12. My daughter had more seizures longer and bad when insurance said had to try Gabapentin she was on nurton sorry for spelling when she went back she was better and the same happened when she was on topmax and switched to non brand she brand name only on all her meds

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  13. i dont do very well on most generics especially large doses. small doses on some i do fine on.

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  14. This study is flat out wrong. I was seizure free for 15 years until I switched from brand name Lamictal to generic. I have also had problems switching between the generic made by 2 different companies. This was NOT a nocebo effect as I was more than willing to go on a generic to save money, and I had no prior knowledge of any problems with switching to generic for this drug. It is irresponsible for this researcher to conclude that there is no problem with any generic drug based on his study with a mere 35 patients.

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  15. My son went from a seizure every 3 months to 4 seizures the first 3 days. His body clearly didn’t see them as the same, despite what this probably self-serving study says.

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  16. This didn’t strate who FUNDED the study, only who did it. Very important to know. The LAW states a generic must be 80% effective 80% of the time, fillersn binders, colors affect the delivery of the medication, that’s why there is a negative formulary of drugs that CANNOT be subsituted in each state. Do not be fooled.

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