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FDA Sponsors Research to Determine if Generic Epilepsy Drugs are Truly as Effective as Brand Names

name brand vs generic epilepsy drugsThe University of Cincinnati expects to begin a study regarding certain types of epilepsy drugs in March.

“The FDA, last year, decided that they would fund the study to look at how much difference there is between generic drugs and brand name drugs,” said Michael Privitera, a neurologist at UC and the principle investigator of the study. “Some doctors and some patients have complained that when [people with epilepsy] switch from the brand name drug to the generic drugs that they were losing control of the seizures or they were having too many side effects.”

The FDA believes there is enough research for doctors to trust generic drugs to be as effective as the name brand drugs.

“What we’re really testing is whether the FDA protocol to test generic drugs really works in the real world with people with the disorder taking a lot of other medicines,” he said.  “When the FDA tests generic drugs, it tests them in normal volunteers, which is a big difference because a lot of these people with epilepsy may be taking three, four or five drugs at a time.”

Approximately $2.6 million in funds will be allocated for the study, Privitera said.

Approximately $1.6 million came from the FDA and $500,000 from the American Epilepsy Society and the Epilepsy Foundation.

“Majority of the money goes to the blood testing and testing of the different generic products in the lab,” Privitera said.

The study will be conducted at several different sites but led by Privitera at UC and Michael Berg, a medical professional at University of Rochester.

“The majority of the money will be distributed based on the number of patients in the study [at each site],” Privitera said.

UC expects the study to take 15 to 18 months to complete, Privitera said.

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24 Comments

  1. Absolutely not! My daughter never achieved good seizure control until I appealed to the insurance company and got name brand Depakote approved. She now has a more steady, reliable absorption of the medicine in her system. I am thankful for trying this step during our attempt at steady control. It was just what she needed.

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  2. As one who never had an issue with use of generics, I have to say that I learned first hand that in many instances, they aren’t. My son used to be on Topamax to control his seizures. Back then, it was GUARANTEED that if he went 48 hrs or more w/o his meds, he would seize. Once, without my knwoledge, the pharmacy filled his usual prescription, but used the generic instead of the name brand. Two days later, he starts seizing, and for the life of me, we couldn’t determine why. I counted the pills (30-day supply, 4 per day), a few times to be sure he hadn’t missed a dose. Rushed him to the e.r. after a few days of him constantly seizing. Of course, they weren’t able to find any issues, and he wound up being hospitalized (he’d gotten seriously injured due to seizures) where he was then administered the brand name of the drug, adn was doing well. As soon as we returned home, the problem resurrected. Thankfully, I journal, and decided to watch my son to be sure he was taking his meds and docment the process, etc. I noticed the pills looked a bit different than what I remembered, and discovered they were the generics, which was the only “change” in my son’s routine at the time. Neuro agreed, and began placing “name brand medically necessary” on all his scripts after that. Now, he’s on 3 meds, all of which are deemed medically necessary. There is a difference

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  3. FDA? Really?! Agree with Heather. Depends on the patient. I’m fine with generics. My daughter is not. EVER. It’s the inert ingredients – the fillers, dyes, and binders. Quoted from a research article: “Epilepsy Newfoundland and Labrador, an information and advocacy organization, notes:
    The active ingredient that helps control your seizures is the same in both ‘brand’ and ‘generic’ names but the substances that are used as fillers, dyes, or binders, sometimes differ. This can occasionally make a difference in how quickly they are absorbed from your stomach or processed by your body. This may affect how much medicine you need. Some people are allergic to some excipients. In addition, a person’s body may have become accustomed to the entire mix of active an inactive ingredients in one manufacturer’s drug, and changing the mixture – even if there is no allergy to a new ingredient – may cause a change in response to the medication.”
    We found the pharmacies change generics often, which triggered her seizures while on generics. ONLY name brand for her from now on. Head lines on studies like this can be sooooo misleading……..

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  4. Also….binders often contain gluten of some sort. Some (many) with E are gluten intollerant….or have celiac related issues. Binders are sneaky culprits of intestinal issues…and build up gluten can block absorption of the very meds we take to prevent the seizures in the first place.

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  5. Karyn – thank you for the educated responses! The gluten issue is something I hadn’t previously discovered…

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  6. You’re so welcome. Together we’ll all find the answers we seek. I’ve done much research on the path searching for my daughter’s answer. Gluten is really something else. Dr’s might test for it but often they’ll just do a quick swab for saliva and rule it out. They have to do more thorough test (escapes me right now) which yields a better result. Glutten can block absorption of nutrients, also, which is vital for proper metabolizing of meds…not to mention the absorbtion of meds themselves. 🙂

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  7. My daughter is on generics due to insurance and is being controlled. but 18 months ago she was admitted due to seizures and when they tested her levels her meds were not showing up and she was taking her meds as scheduled. i personally believe that when it comes to anti seizure meds generic should not be allowed but with the high price what can you do. i cannot afford 600 a month for name brand medication.

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    • Hi Michele,

      My daughter is currently on Generic medications but only somewhat controlled with her seizures. I did some research into switching her to the Brand name. She is on Lamictal. My insurance also has a higher initial cost especially! The retail value/ value without insurance on her medication is $2200 per month. Certainly not affordable! The manufacturer of the brand name, Glaxosmithkline, has a copay card. This would discount my copay monthly by $40. In my case this would drop my copay from $100 per month to $60 per month. It is worth looking at the manufacturer of the Brand medication you may need to switch your daughter to.

      Best wishes and prayers to you an your family.

    • Profile photo of pamela_boodram

      Michele,
      I also had problems with my insurance covering the “brand name” medication for my daughter. I was told by my HR department that there is a form the doctors can submit to the FDA. It is called the MEDWATCH form. You can actually google it and send to your doctor for them to fill out and send in. After the doctor completed the form and it was sent in and the insurance company was told we were able to get her medication covered. Ask your doctor about it. It saved us $300/month

  8. Michele – so frustrating. I found this for you..might help? “Beginning 2011, the Act will provide a 50 percent discount on brand-name drugs in the donut hole, and will completely close the gap for all prescription drugs by 2020.” this is if you have medicare/medicade or SSDI. I don’t…do you? Here’s the link. http://www.epilepsyfoundation.org/aboutepilepsy/Diagnosis/yourhealthcareteam/health-insurance.cfm

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  9. I stopped using generic of any kind once my daughter diagnosed with epilepsy. I did a lot of research on generic versus name brand when the keppra (leviteracetam- generic brand) was not stopping break thru seizures. As previously stated in earlier posts it boils down to the binders, fillers and the inconsistent dosage amount in each pill. Generic does not guarantee a certain level of the drug is maintained in the blood stream. It’s like being on a roller coaster and with epilepsy that’s a dangerous roller coaster to be on. My daughter now on Zonagran name brand. Couple of times pharmacy tries to change. I check each prescript before leaving counter, plus the price always a giveaway. We forgo things so I can pay the high cost of name brand. Well worth every penny in my opinion. We need to be lobbying Washington for better insurance coverage with name brands. Hope to be doing just that in the near future.

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  10. FDA sponsors research. Yeah right. That’s like generic versus name brand right there. FDA will do or say anything that continues fur lining their pockets to the bank. The FDA could care less about the real facts on generic medication. FDA is part of Washington and look what Washington is doing to this country. If their research shows generic is as good as name brand I beat they have some beach front property in Oklahoma to sell you too.

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  11. Well, University of Cincinnati Medical Research is actually conducting the study…so we can only hope that they are more objective with their findings than FDA organized studies…

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  12. but who’s SPONSORING the study….sometimes matters little who’s conducting it. Gotta follow the funding. Sad to say.

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  13. FDA is sponsoring it. I’d certainly read between the lines when reviewing the data they use.

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  14. It seems like no one trusts the FDA anymore. Why does it exist?

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  15. Profile photo of pamela_boodram

    After reading this article and the comments below it is obvious that there is a link between generics and the increase in seizure activity vs. brand name drugs. My daughter (like many above stated) also showed an increase in her seizure activity when she was switched to generic versions of her AED’s. We even tested it out and verified that with the brand name drugs her seizures were better managed. Of course the brand names are very expensive and most insurances won’t cover the cost of the brand names when a generic is available. I argued with our insurance company but was able to get them covered with the help with an equally pushy HR person from my employer. She was able to get a MEDWATCH form from the FDA website. You can actually pull the form yourself and hand it to your doctor to complete. They send it to the FDA and should contact your insurance. Basically the form is documenting that the doctor has tried generic drugs and there has been a significant difference in the generic vs. brand name drug. Our insurance (Express Scripts with CIGNA) then contacted me to let me know that the brand name drug would now be covered for our daughter. I was told that it was good for a year but that I would just have to send in the form again in a year.

    It is just so frustrating to have to go through all this hassle to have the medication that is life or death in some cases approved by insurance.

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  16. My son experienced more breakthrough seizures on generics…

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  17. Um? The have to be per FDA standards… just wow, fda.

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  18. Um? They have to meet the same standards per FDA regulation… just wow, fda; focus more on getting arsenic out of our foods, water, etc.

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  19. Generics have never worked as well for me – I always have breakthrough seizure with them…

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  20. I am on Lamictal and since the generic version came out my insurance company has been charging me a higher co-pays. I am pregnant and had to increase my dosage and now just found out that our plan has a $7500/year limit on drugs. Since Lamictal is so expensive we have almost reached our cap and will have to pay out of pocket 35% of the cost of the medication. I feel that all these things are just ways of trying to push people to generics. I am seizure free for 8 years. Why should I risk 8 years of success because the insurance companies and drug companies are concerned with their profits. This is my life. Should I risk injury or death to myself or others? I need this medication to live just as a diabetic needs insulin. I feel so helpless, like there isn’t any recourse for epileptics. I am hoping some legislation will change this. I am planning on contacting my congressman in hopes that something can be done in the near future to help people with epilepsy.

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  21. I have an autistic daughter who suffers from seizures. They were uncontrolled for years. Switching to brand name helped a lot. I guess it depends on person because I know people who do well on generics. For people who are continually having seizure issues, it should standard medical practice to consider if brand name epilepsy medication will solve the problem.

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  22. Here, let me save you time, money and energy on yet ANOTHER study that will most likely lie to us about generic drugs. Let’s quit beating around the bush here, okay? Let’s just admit the truth. Generic drugs, medications for epilepsy should be OUTLAWED. Generic drugs for epilepsy are DANGEROUS. There is just no sane, logical reason why our congress and FDA has not yet outlawed generic drugs for anyone with epilepsy. NO MORE generic drugs for epilepsy. If generic drugs were outlawed for people with epilepsy, the USA would save MILLIONS in unnecessary 911 calls and long, costly hospital stays. Neurologists should be protesting in the streets over this outrageous neglect of patient in healthcare. The epileptic brain does NOT respond well to the fillers and inconsistent doses found in unregulated generics. And NO I’m not a shill for brand name drug companies. Do your research. It’s right there. Ask anyone who has suffered for years from chronic seizures. Or has experienced the ups and downs of generic epileptic drugs. It’s an absolute healthcare nightmare. And it needs to stop now. No more generic drugs for patients with epilepsy. There shouldn’t even be an argument over something so ridiculously obvious.

    Reply

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