Topamax Settlement Results in $81M Payment Over Off-Label Promotion

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Following whistleblower lawsuits filed against Johnson & Johnson subsidiaries over illegal marketing and promotion for the epilepsy drug Topamax, the Justice Department has reached a settlement of $81 million with the drug makers.

Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals have admitted that they promoted Topamax between 2001 and 2003 for uses that were not approved by the FDA. Under the terms of the Topamax settlement, Ortho-McNeil Pharmaceutical will plead guilty to a criminal misdemeanor violation and pay a $6.1 million fine. Ortho-McNeil-Janssen Pharmaceuticals has agreed to pay more than $75 million.

Although Topamax was only approved for treatment of epilepsy and preventing headaches, the medication was promoted for unapproved psychiatric uses. The drug makers had outside physicians join sales representatives when they visited health care providers and spoke at meetings and dinners about prescribing Topamax for psychiatric uses that were not approved by the FDA as safe and effective.

The allegations were brought to the federal government’s attention after two individuals filed whistleblower lawsuits under the False Claims Act. As a result of the settlement, whistleblower compensation of more than $9 million will be paid to the individuals who brought the suits.

Topamax (topiramate) generated more than $2 billion in annual sales for Johnson & Johnson before a generic version became available last year. Side effects of Topamax have been linked to an increased risk of suicide and suicidal thoughts, which has been added to a black box warning for the medication and other epilepsy drugs. Research has also linked the use of the drug during pregnancy to a risk of Topamax birth defects, such as cleft lips, cleft palates, genital defects and other birth malformations.

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  1. BOYD Reply


  2. Bonnie Reply

    I was put on topomax over 15 years ago; being a heart patient and developing many problems with no answers until now

  3. Shonda Reply

    I took topomax for about a month for migraines. I have high blood pressure, but it as controlled and was not a problem. Other than that, I have no major health concerns. After one day of an increase in dosage from 25mg to 50 mg, I developed acute narrow angle glaucoma and basically lost the ability to see anything other than blurred objects for 4 days. Eventually, my sight improved to the point where I could see using my eye glasses, but my eyes are forever damaged and now I am basically blind without my glasses. Before, I only had slight astigmatism. I had been checked thoueroughly for eye problems each year due to the fact I wear glasses and never had a vision problem or glaucoma. I also had diagnostic imaging of my eyes performed as part of a routine eye exam a few months before the incident with Topamax. My eyes were ruled to be healthy with no visual problems other than astigmatism. Thankfully I stopped taking the medicine abruptly when this happened, even though my dr wanted me to continue taking it for two days. If I had listened, I would have been permanently blind.

  4. Anne Reply

    I was prescribed Topamax 300 mgs a day for my seizure’s and migranes. I last all feeling in my body and my sex drive was gone. My dosages was lower to 50 mgs. After 6 months I quit taking it, but I still have no feeling in certain parts of my body. If you have a choice to take another drug, you should.

  5. Thomas Reply

    My mother has been on Topamax for about 3 years and during 3 years she has experienced alot of side effects but her doctor keeps telling her to take it for her migraine and recently a few months ago, she experienced and encountered a severe closed angle glaucoma attack on her left eye and could be potentially blind anytime. So I wonder if there is anyone out there experiences or encounters the same problem we can pool together as a big group in order to file a lawsuit so Law firms are able to pool their resources and share the results of their investigation and pretrial discovery in order to strengthen the cases and meet the challenges posed by the large pharmaceutical corporations. Please if you know anyone and please join us by pooling together so we can file this class action lawsuit. Thanks

  6. joyce Reply

    i was put on topmax in march 2008 for migraines 100mg aday i did not know what was happing to me. i just set, i did not know what to do in my home. it messed me up so bad still not over it. about 8 months later my hair started coming out by the handfulls till i was almost bald i had to go get awig. i called the dr. and told her my hair had come out i went in the next day she took me straght off of it . never heard from her again. i still have trouble with every thing i do .my daughter just wants her mom back. she is a nurse she knows it did something to my mind , she tells me all the time that i am not the same. i still have trouble going out in my yard and i used to stay in my yard all the tme

  7. renee Reply

    i have written my comments before and it has not done me any good nobody will contact me to give me any info on this sorry drug. when is somebody going to do something about it. I did not know that yopmax is the reason for me to have to surgery on my eye lids so i did not loose my eyes. there are so many things that this drug has done to me i can not even tell all of then. i have suffered enough.

  8. dawn Reply

    I am currently taking Topamax (ie-Topriramate) 150mg. for Bi-polar mood disorder. The Doctor want to keep increasing my dose , I first started on 25mg. and increase in 25mg,increments until I reached 100mg.. all in the course of two weeks, then he increased the dose another 50 mg.T hats when I began to notice a definite change in vision.He wanted to increase my dose yet another 50 mg the following week. i declined. I consulted my eye doctor, and spoke to him concerning the sudden change in vision , I had just been given a new lens prescription 2-2010, They suggested I get checked for diabetes, I will. but I am inclined to believe that he Topamax is the reason.

  9. Anna Reply

    I was prescribed Topamax for an off-label use from 2003-2006– is the fine being disbursed to patients, or only to government and lawyers?

  10. Sharry Reply

    I am on Topamax 200 mg. twice a day for Bipolar disorder. My vision got worse, my eyes started burning so I made a eye appointment. The eye doctor told me I have cataracts in both eyes. He also said I am quite young for the cataracts.

  11. Peggy Reply

    I would like to know if anyone has had increase anger uncontrolable meanness while on this medication foe headaches.
    My husband was prescribed this med then my daughter a few yaers later. Both are calm people until starting this medication with in days they became easly angered, forgetful of simple things like basic math,spelling,phone numbers ect.
    They stopped taking it and went back to normal, just wondering if anyothers had this effect.

  12. joe Reply

    i started taking this medication in 2008. I had a bad dreams and started to get blackouts with my antidepressant medication. I had a full week of total blackout that I remember little of each day it ended with me taking my bottle of sleeping pills to end my life. So yes prior to taking this medication I never had black outs like I did, needless to say I was rushed to a hospital and ended up in a mental institution for days my advised to anyone out there do not use this drug I should have died if my wife was not home I would not be sharing this.

  13. Micah Reply

    I hve had a long road with topamax. I have been on it since 2000 or 2001. I have tried to end my life and ended up in the mental hospital over 4 times. I refuse to drive at night because my vision is so bad, and I had no idea what i thought was supose to be making me better is the cause. I take 400 mg a day, and I am getting it through johnson and johnson. I have taken both the original and the generic. Now I always want to be alone. And I have no interest in my relationship or a sex drive, and have had more suicidal thoughts than ever. I also hate to sleep because the dreams I have are so graphic and horrible I wanke up not knowing what is real and what I dreamt. Its intense and exosting. Im not sure if extreme rapid weight change is a side affect either, but that has happend as well. I was just incresed another 100 mg this last 6 months.

  14. jennifer Reply

    I was just hospitalized with acute pancreatitis with pseudo cysts. Both lungs filled with fluid and almost collapsed. Was told by Doctors it was most likely caused by Topamax.

  15. Dianna Reply

    In late 2007 I was prescribed Topamax 25mg/day for Bipolar and what the Dr said would help with weight loss. I don’t like hearing about most side effects because I am afraid I will look for them and my brain would create the issues. So I took the meds. Within two weeks, I was taking 200 mg a day. Suddenly I started having random visual and audio hallucinations. I thought I was going nuts! I felt like I was dying. Time would slow down to feeling non existant, I even blinked and “woke up” on the floor….never knowing what happened or how long I was out for. After telling my Dr, he only said “Yeah, those are some side effects. We in the medical industry call it DOPE-A-Max. He weined me off of it, but the hallucinations didn’t stop. They aren’t as often now, but happen still and I have been off the meds for about 5 years. My memory also got really bad at the same time. I used to be a script actress and my memory was always fantastic. I’m only 30 and now memorizing lines is nearly impossible for me. I can’t remember random, simple words a lit of days. I will ask my kids to put something in the trash and go through about 7 other words before I get to where I am trying to go.
    I never had those issues before topamax, and though I am no Dr, I have a very big feeling the Med had a lot to do with what I am going through. Perhaps it kicked something on (or off?) In my head. Scary. Especially with two young children around.
    Anyone else had ANY of these effects??

  16. Hayley Reply

    I had severe pain in both eyes while on topamax, when I stopped taking it my right eye returned to normal however my left is still painful, I have this every day yet my exam is normal.

  17. Tonya Reply

    wow!!!! after reading this i know that topomax is truly the cause of alot of my problems….i started out on 25mg then 50…went up to100 twice a day then 200 twice a day…i am only 33 years old and still suffer with migraine headches but also have had so many other problems since taking topomax,just recently fell out literally and was admitted in the hospital near dead…suffering with accute pancreatis and no known reason why?????i have alot of forgetful moments myself and mispells where as i use to not have….Wow…so many others out there goin through the same thing…i hope it gets better for you as well…my mind is made up.. no topomax for me!!!!!!!!!!!!!
    I could have died and then who wd my children have to depend on??????????????????????just a couple of months ago still no answers

  18. Priscilla Reply

    I took Topomax for two years for migraines which I still have and started losing my vision a few months later. My eye doctor says Topomax is the cause of my eyes going bad.

  19. Mitra Reply

    Topamax ruined my life. I was hallucinating so bad, I was seeing bugs, ticks, bedbegs, fleas, and redbugs. Everything smelled like urine. I spent a 100 on laundry detergent every week and still ran out. I traded a perfectly good luxury vehicle 5 months before it was to be paid in full. I felt unknown heat in my thighs. I bought all the bug spray that’s known to man. I had my car detailed so many times. I lost a lot of weight bc I spent my lunch break at car wash using the vaccuum at least twice a day. I went from having long hair to short hair. I threw all my designer clothes away bc I thought they stink. I took baths 3 times a day. I prayed for god to take me out of here. The moles in my face looked like ticks and I pulled all of them off. My family didn’t want me to come over bc they thought I would bring them bugs. I went to dermatologist for my skin and she tried to prescribe Risperdal. I Came home with that medicine and prayed, lord this is not me I refuse to take this Risperdal. I cried please help me god. I went on the internet to research Risperdal and it said something about pschzophrenic read all the signs and I was the one described last the one who is not in touch with reality and hallucinate. I didn’t take another pill, I walked around my house and smelled stuff and everything was smelling good, Prayer changes, this is very embarrassing to share.

  20. lemeta Reply

    i have been taking topamax since 2003 or longer i have never heard of aphasia until noe i have burning sensation on the top of my head and i gwt bad headaches and my face twitches and my eye lid twitch and it my words com out wrong and slurd sometimes what i want to know is when did they put the warning out

  21. Davina Reply

    I have endured a year of hell on Topamax. I constantly had herpes outbreaks after 26 years of having herpes and seldom ever having an outbreak. The outbreaks were horrible and nothing helped. I was on 3 antivirals and still having constant herpes pain. I had thoughts of suicide constantly due to the pain. My GYN referred me to my neurologist for post herpatic neuralgia. When I explained what was going on, he said it was probably the topamax and had me try stopping it. 3 days after stopping topamax, I was back to normal. I haven’t had any herpes symptoms since then.

  22. Delores Reply

    I was on a hundred milligrams of Topiramate for bipolar disorder within 3 weeks I had developed carpal tunnel syndrome full blown in my left hand and was in need of surgery just from a 100 milligram increase I was in so much pain from that Med increase and the side effect of being for copper tunnel I was up crying every night 3 o’clock in the morning I want to cut my hand off and put it on my dresser until the next morning the pain was excruciating the Topamax increase was too much and the correlation from the research done actually said Topamax is directly linked to one of the severe side effects one being copper tunnel syndrome I m disgustedly It Off the medication that’s supposed to relieve one thing gives you another now I may never have feeling in my left hand ever again and the worst part is I have a six-month-old grandbaby that’s a little chubby wubby and I can’t even hold her without somebody being in the wrong because I have no feeling I miss hold hand and I would never forgive myself if I dropped her thank you Topamax but no thank you it sucks being a guinea pig

  23. Wendy Reply

    I really don’t understand how a drug can cause eyes to leak and glaucoma and pancreatitis which one never had prior. FYI pancreatitis is exstremly painful. Not to mention the other side effects I am too embarrassed to even put. No this is horrible. Any drug manufacturer admits this is s dangerous drug and it’s like cancer it will strike any weaknesses and exasterbate them. But no one will do a thing about it because how in the world do you prove a dam thing except your life is in the gutter from the Garabage. Amazed they still sell the Garabage. Another drug to cause people to have to go to more doctors if they don’t blow their brains out first from basically going blind and not taking the pain. Oh well no big deal. just a joke in my book. Not a thing will be done due to the three yr limitation. Oh and I wasn’t pregnant another reason they dint care.pancreatitus and glaucoma are just the beginning with losing your hair your mind then your life.

  24. Amanda Reply

    I was also on topamax 100mg twice a day I experienced problems with my eyesight hair loss body numbness also suffered attacks of being fully blind for short periods of time flashing lights and symptoms of mini strokes my doctor told me not to worry about it and keep taking meds I quit taking meds against medical advice and for the most part symptoms improved except problems in eyes I was born clinically blind but was partially corrected with glasses

  25. Shannon Reply

    I was on Topamax for about 2 years. I took 100mg twice a day(200mg) for migraine prevention. It helped prevent the migraines and I lost a little weight, however I did have trouble “finding words” that I wanted to say and extra memory issues (I’ve had an aneurysm clipped). About a year after taking this drug my family thought I was possessed (and so did I), but now I think it may have been hallucinations. It was so bad that the Bishop gave the okay for a priest to perform exorcisms on me (about 7 times), bless my house several times and help me get rid of items that might attract negative spirits. (Crystal balls, fairies, dragons, etc). Things started to settle down, but I still have auditory hallucinations (no visual). I guess I will only know the truth about what happened to me when I meet my Father in heaven. Then I will know if it was PHARMAKEIA (sorcery in the Bible) that caused it, or if I was truly possessed… Awful medication! I am now divorced after 15 years and the “episodes” I had are partially to blame.

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