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

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By: AboutLawsuits | Published: May 3rd, 2010

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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There Are 17 Comments So Far • (Add Your Comments)

  1. I WENT TO A DR. WITH COMPLICATIONS TO CARPAL TUNNEL SYNDROM, HE PRESCRIBED TOPAMAX 25 mg/ 1 @ HOUR OF SLEEP. I TOOK 11 DOSES AND HAD A SEVERE CLOSED ANGLE GLAUCOMA ATTACK AND NOW I AM BLIND IN MY RIGHT EYE AND AM DIAGNOSED NOW WITH SEVERE GLAUCOMA. MY OPTHAMOLOGIST CREDITS TOPAMAX WITH THE CAUSE OF THE REACTION. I WAS NEVER DIAGNOSED WITH GLAUCOMA BEFORE THIS.

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

  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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