Legal News Watch - Consumer Rights Blog

F.D.A. Says Johnson & Johnson Topamax Sales Materials Misleading

September 27th, 2004 · 19 Comments

The U.S. Food and Drug Administration said that certain sales materials for Johnson & Johnson’s epilepsy drug Topamax omit important risk information, in violation of the Federal Food, Drug, and Cosmetic Act, and asked the company to immediately cease the dissemination of them.

The agency said, in a letter sent to Johnson & Johnson unit Ortho-McNeil, that a sales aid, two case study flashcards and certain sections of the Topamax web site fail to disclose any information about the serious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis.

“These materials raise serious public health concerns because they encourage the unsafe use of Topamax, including, particularly, in pediatric patients,” the F.D.A wrote.

The F.D.A. asked the company to submit a written response to the letter on or before September 29, 2004 describing their intent to comply with its request.

(via U.S. Food and Drug Administration)

Share and Enjoy:These icons link to social bookmarking sites where readers can share and discover new web pages.
  • del.icio.us
  • digg
  • Furl
  • Ma.gnolia
  • NewsVine
  • Reddit
  • Simpy
  • Spurl
  • TailRank
  • YahooMyWeb

Tags: Topamax

19 responses so far ↓

  • melanie // Dec 14, 2004 at 11:18 pm

    hi i am really concerned about this issue what is going on i am taking 25 mg of topamx 6x a day whats up with that am i ok whats wrong i dont understand somebody answer me please im also taking effexor 150mg once aday nothing seems safe any more

  • ElAnya Nightingale // Feb 16, 2005 at 7:42 am

    I have been on Topamax for 6 months and am getting off of it because it has A) damaged my eyes, B) Made me unable to function as a normal person in society and C) possibly cause other health problems. This is a DANGEROUS DRUG, and Doctors are prescribing it off-label willy-nilly, without being aware of the potential consequenses!! I may have paid the ultimate price for my doctor’s ignorance, and for this company’s bad marketing practices.

  • melinda // Mar 2, 2005 at 1:04 pm

    I lost my son age 2 to the drug topamax and was never told that a 2 yr old should not be on 400mgs a day of topamax and that the side effects are worse than the results. Any one who has taken this product should be tested for liver failure and not just from blood work. get an ultrasound. i was not told about the side effects and now that it is to late i know he had some of the most severe reactions and almost all of the signs of an overdose from the beging. We were told that it was normal.

  • BOYD CONLEY // Apr 18, 2005 at 8:35 am

    I took 11 doses @25mg.of topamax ea. and now i am blind in my right eye and have lost 30% of my vision in my left.due to an acute angled glaucoma attack . i spent 14 days every day in the opthamologists’ office receiving aggressive care to prevent what happened to me from happening. to no avail did it prevent anything. My life as a nurse is over ,because i can’t even see to write my name.This situation has made me very bitter about the availability of dangerous drugs that are lurking to ruin somebody elses life.

  • Judy // Apr 30, 2005 at 2:44 pm

    I stopped taking Topamax after almost 4 months and have several serious side effects. My eyesight has gone from slightly farsighted to being far worse in a very short period. I have had accidents (including a car accident) due to the fact that it slows your coordination and reaction time.It has made me very sad and anxious, when I had never had such strong mood swings before. And that is not all. My MD told me NOTHING about any of the potential side effects. Should this drug really be on the market? Does the company have any responsibility here?

  • Judy // Apr 30, 2005 at 2:45 pm

    I stopped taking Topamax after almost 4 months and have several serious side effects. My eyesight has gone from slightly farsighted to being far worse in a very short period. I have had accidents (including a car accident) due to the fact that it slows your coordination and reaction time.It has made me very sad and anxious, when I had never had such strong mood swings before. And that is not all. My MD told me NOTHING about any of the potential side effects. Should this drug really be on the market? Does the company have any responsibility here?

  • S. M. // May 23, 2005 at 5:59 pm

    I was prescribed Topamax to help me sleep, cut down on bad dreams and reduce morning migraines. I stopped taking it and I have also noticed a reduction in my sight. I now need better glasses. Maybe I’m fortunate I stopped this stuff on my own. For awhile it was working- I wasn’t waking up sick with migraines for the first time in my life. But at what price??

  • Shelley Morgan // Jun 5, 2005 at 8:14 am

    I’ve been on topamax for 8 yrs as part of my medication regime for seizures. I was never told of the adverse side effects nor are they on the label. I literally went insane, hallucinations, heteroagressive behavior, inability to distinguish between dreams and reality, blurred vision. I was incarcerated twice for domestic violence and released twice with charges dropped after the detective on the case listened to my fiances description of the adverse side effects of Topamax, not easily found. I’ve lost my children over the years to their father because of these side effects.

    The whole time thinking something was wrong with me mentally. None of this imformation is on the label. I’m now reading about people commiting suicide while the drug was in stage 2 trials. Because these effects happen in less than one percent of patients it is not on the package insert or on the label itself.

    I’ve contacted a great malpractice attorney here in los angeles and am pursuing a class action law suite if you ‘d like to join me please email me and i will forward you the attorneys name. I finally found a nuerologist who has been slowly taking me off the drug. The results of this were almost immediate. I feel wonderful and all side effects are gone. It’s time to make them pay and change the way adverse effects are reported on labels and package inserts.

    shelley morgan

  • Angela // Jun 10, 2005 at 7:04 pm

    Hi, I was recently put on Topamax to control migraines. I was not really told about the serious side effects, just the tingling feeling and the bad taste of carbonates sodas is really all I was told. I developed narrow angle glaucoma and the opthamologist believes it is a direct result of the Topamax. The pressures in my eyes were up in the 50’s when they should be around 15. I had to have emergency surgery in both eyes and thanks to the quick reaction of opthamologists they were able to save some of my vision. I have lost peripheral, night vision, and some distance vision. For those of you having vision changes, I encourage you to go to see an eye doctor immediately. It may save your vision before it is too late. The neurologist of course says the medication is safe to continue taking, the opthamologist says there is a new warning issued out on Topamax that lists narrow angle glaucoma as a serious side effect. If it’s not caught in time it will leave you blind.

  • Caroline // Jun 14, 2005 at 12:09 pm

    I have been on 200 Topamax and 225 of Effexor now for 3 years, occasionally, because of taking a SSRI( effexor) long term my doctor will precribe 10 days worth of wellbutrin. I have never felt better. I have never had any adverse effects to the Topamax other the tingle in the feet and hands and that is occasional and tolerable. Yes, there are good meds out there, and yes, good meds can sometimes to bad things to people if they don’t take them the way they are intended. There are also some bad docs out there that don’t have a clue. The saying is what do you call some one who graduates dead last in his/ her class in med school? Doctor…Your health is ultimately up to you.

  • Lisa // Jun 27, 2005 at 12:44 pm

    I think it’s a crime that my father was put on Topamax for his migraines. He initially had symptomatic relief with Imitrex, but his doctor authorized its daily use. So when Imitrex quit being effective, due rebound headaches, my father’s doctor prescribed Topamax. The doctor should have been working with my father on treating the source of his headaches, which I believe is a stress disorder. My father is susceptible to kidney stones and works in physically dangerous conditions. How could these doctors have ethically prescribed Topamax knowing that he needs to have his full mental faculties for work, and knowing of his susceptibility to kidney stones?

    Don’t doctors check-up on the medications they prescribe? My father said that his urologist knew nothing about Topamax causing kidney stones, and approved the prescription, and that the product insert said nothing about kidney stones.

  • Janet // Jul 12, 2005 at 10:51 pm

    I have been on Topamax 300 mg for a couple of years which controlled my headaches, seizures and worked as a mood stablizer real well. However I had been complaining about loss of memory, confusion, and recently the headaches came back and my eyes hurt and jiggled. I had my eyes checked, they were physically fine. My doctor cut me back to 200 mg of Topamax and started me slowly on Lamictal until I could get to a Neurologist to take me completely off of Topamax. Just this small reduction has helped reduce the headaches and the pain in my eyes. If changing medicine will help with all that I am having problems with I will be happy. I really feel the Topamax is the culprit with the headaches and the eye problems and partially the problem with memory loss and confusion. So beware if you are having similar problems.

  • Kimberly Duff // Jul 14, 2005 at 12:25 pm

    I want people to hear your stories and concerns. I want to make a documentary on this drug and show people how dangerous it is. Just a website is never going to be enough to get this message across. Email me @ keduff203@yahoo.com if you wish to be apart of this and are willing to tell me your whole story. People need to know the REAL side effects of this drug and what they’re putting at risk; they’re lives.

  • Ed // Jul 20, 2005 at 11:35 pm

    Ok, now I’m scared… I just started taking this yesterday, I thought I would do anything to get rid of my chronic migraines, but my spelling is already worse, my attention span is gone, cola tastes like it’s flat and had something really horrible added, and none of this was mentioned by my Dr., I hope it’s because he wasn’t aware, he has always been very knowledgeable and caring in the past… should I stop taking this right away? or call him first?

  • Angela // Jul 24, 2005 at 9:52 am

    Just because some of us had really bad side effects from it doesn’t necessarily mean you will. Both my aunt and sister-in-law were both put on the Topamax for the migraines and had no problems with it…it’s actually helped them. The reason for my posting was because many people are not told of the severe side effects like eye damage that affected me. Doctors are prescribing it but not warning of all the side effects. Please make yourself totally aware of all the side effects just in case. Good luck to you!

  • Karen // Aug 30, 2005 at 10:36 am

    A neurologist put my 12 yr. old neice on 100 mg a day of this topamax for her migraines. I told him that’s too much, that’s the amount for an adult. He says she gets that much cuz she’s 185 lbs. This stuff hits your temporal lobes in your brain, not your stomach! And a twelve year olds brain is still developing! Migraines have stopped at 50 mgs. (while titrating). Should I seek second opinion.?

  • Colleen // Aug 30, 2005 at 11:05 am

    i have been on topamax for just over one year….the most insame year of my life…i’d rather have the migranes The neurologist couldn’t find a comfortable dosage from the beginning…it seemed like i could only handle 50mg a night and i myself decided to take it in two doses…the side afftedcts were everything described…memory loss, short attention span, sleepy, moody…depression, then my GP put me on adivan, then finally Effor, more side effects. I have now bewen off work for a month with seizures, loss of vision, exhaustion, i literally almost died. my husband knew if was the meds and convinced another neurologist to start taking me off them. after a couple of weeks i started to feel my head clear. i got print outs from the pharmacy…4 of 5 meds i was on were all not supposed to be prescribed with one another…..my GP prescribed them along with the neurologist who had the entire list….I have had seizures!!!!!!! MAKE SURE YOU STOP THE MEDICATION AT THE EARLIEST SIGNS, DO NOT WAIT UNTL YOU HAVE PERMANENT VISION LOSS OR WORSE!!!! HAVE A LOVED ONE CHECK ALL OF YOUR MEDS, EVEN OVER THE COUNTER FOR DRUG INDICATIONS.

  • veronica // Sep 20, 2005 at 7:20 am

    this stuff nearly killed me !

    I was on it - then off it - but developed hives like welts all over my body that itched & burned -

    I finally got a cortizone shot & it was then realized that it is a sulfer based drug & i have an allergy to it !

    it had built up in my system enough the first time - that upon continuing it the 2nd time around - it was near fatal !

  • Laurelle // Oct 7, 2005 at 10:35 am

    I was just prescribed topamax yesterday, I am terrified to have it filled from reading this site. I was prescribed it because of a chronic burning pain in my upper back. I am also taking celexa and oxycontin for chronic pain. What should I do?

You must log in to post a comment.