FDA Panel Recommends Against Epilepsy Drug Black Box Warning
The U.S. Food and Drug Administration (FDA) convened an advisory panel last week to evaluate the risk of suicide associated with epilepsy drugs, and to make recommendations about what regulatory actions should be taken to protect consumers. Although FDA officials indicated they believe a “black box” warning should be placed on the drugs, the independent panel recommended against such a strong warning at a hearing on July 10, 2008.
FDA advisory panels consist of external medical experts who are brought together by the agency to provide advice and recommendations. Although the FDA is not bound by the recommendations of their advisor panels, they usually do follow their advice.
The panel was convened after an FDA analysis released in January 2008 identified an increased risk of suicidal thoughts and behavior among users of the epileptic drugs. Data revealed that the anti-seizure medications increased the risk from .22% to .43%, which implies an additional 2 suicides could occur for every 1,000 people taking the drugs.
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Learn MoreAccording to government estimates, nearly 2.7 million Americans suffer from epilepsy, which is a neurological disorder characterized by chronic unprovoked seizures. In 2007, anti-seizure drugs generated sales of over $10 billion, making them the fifth best-selling class of drugs in the United States. GlaxoSmithKline’s Lamictal, Pfizer’s Lyrica and Abbott’s Depakote are some of the top sellers.
The FDA advisory panel did find that the epilepsy drugs carry an increased suicide risk, but did not believe a “black box” warning is necessary. A “black box” warning is the strongest available warning that can be placed on a prescription medication, and it is prominently featured with a black border to draw attention to the seriousness of the risk.
The panel concluded that the risk of suicide was relatively low and there was not enough evidence to justify the use of the FDA’s toughest warning. They suggested that a “black box” warning could scare consumers into not taking their medication, which has been shown to be effective in treating epilepsy. It could also cause doctors to be reluctant in prescribing the drugs.
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12 Comments
BobbieMay 3, 2010 at 9:25 am
I have been taking Topamax for gosh I don't know how many years now. a few years ago I tried to commit suicide by overdose. I did come to my senses not to long after because I started to think about my family in AZ across country that I had not seen and my children and my husband and who would take care of them. I got myself to the hospital barely in time after leaving a note for my husband. But i[Show More]I have been taking Topamax for gosh I don't know how many years now. a few years ago I tried to commit suicide by overdose. I did come to my senses not to long after because I started to think about my family in AZ across country that I had not seen and my children and my husband and who would take care of them. I got myself to the hospital barely in time after leaving a note for my husband. But it did almost ruin my relationship between me and my husband. It did ruin my relationship with my nieces who I was very close to. They felt like they were betrayed my me. I ended up having to go into a mental hospital for about a week then in order to get out I had to sign up to go to a therapy class that I had to go to everyday. I graduated that after about 6 months. Then continued seeing a psychiatrist for a few months until I basically got fired form him because I was 10 minutes late for an appointment after I called them and told them I would be a little late and they said it was okay. Henever really did anything for me anyhow except ask me if I needed any refills or if there were any changes in my symtoms. Nothing about my feelings or anything. Je was always in a hurry because I know he doublebooked his appointments. Anyhow Topamax has also given me many side effects including forgetfulness,depression, tingling in my hands and feet mostly feet, hair fall out, tired and worn out all the time, get brurred vision, hard to concentrate which always made me hard to read which I had always loved to do, I have now discovered that I can now read along with audio books and that is better for anyone that likes to read but can't with Topamax or any other drug. These side effects are a hinder on my relationship with my husband because I hardly ever have any energy and don't want to get up and do too much housework and I wait until the last minute to go to the grocery store when we are just about out of food. I don't know if topamax is the cause of this next problem but I think it is linked to the depression or the Topamax itself but I have NO sexual desire at all. Now that is a big problem on my personal life. I was attending college 2 years ago to be a omputer prgrammer and it was hard for me with the side effects and I was not feeling well enough one day so I stayed home. One thing I had forgot was it was the day of our finals. I was thinking our finals was our following class two days later even though there had been signs all over the scool for a couple weeks and posted on our sylabus online the whole quarter. I did end up being able to make up one of the finals the next day because I contacted my instructors but the other never contacted me back. So because I failed that final I failed that class and lost my financial aid. It was a basic math class and I should have passed it with no proble because I had already passed a basic Algebra class the previous quarter when I had been in Nursing instead of Computer prgramming. ( just know computers a bit and my stomach isnt as strong as it used to be.) I hsve been on a variety of meds since I was diagnosed with epilepsy when I was 12 I am now 35 and Topamax is at the top of the worse I have taken. Topamax, Dilantin(which caused me to lose my teeth), and Depakote(which caused me to throw up all the time(that could have contributed to the bad teeth as well I think since it was acid based.) I know this was pretty long and detailed but I try to give people as many facts as possible. In fact there is probably some I left out.
LorraineApril 20, 2010 at 5:07 pm
On average I was getting about 25 cluster migraines a day. Some days more some days less. I was taking Topamax for this and this is a very dangerous drug! I had several side effects from this medication. Change in taste, kidney stones, muscle pain, memory loss, not able to stand for more then 20 minutes at a time, not able to sleep, neck and shoulder pain. I also had severe depression and suicidal[Show More]On average I was getting about 25 cluster migraines a day. Some days more some days less. I was taking Topamax for this and this is a very dangerous drug! I had several side effects from this medication. Change in taste, kidney stones, muscle pain, memory loss, not able to stand for more then 20 minutes at a time, not able to sleep, neck and shoulder pain. I also had severe depression and suicidal thoughts. I cried all the time. I believe with all my heart had it not been for my two girls needing me I would have ended my life. And there was little relief, I still had the migraines! When I told my doctor that I was having suicidal thoughts since on this medication he told me that this is not a side effect. My doctor and I decided to ween me off of this medication and started taking Kepra. I still have my cluster migraines (about 4 a day) and “normal” migraines that put me out for a day or so but they are not as severe, other then that I feel fine!!! No more depression or suicidal thoughts. Please people talk to your doctor if you have any issues with this medication!!
AndreaMarch 30, 2010 at 9:23 pm
I started taking Topimax 3 months ago for severe migranes. What a miracle drug!!! It cured my migranes unlike any other medication I had ever tried and there were many...Now I am almost weened off of the drug because I experienced, and still are, bad bad bad depression. Although I have suffered from chronic depression my entire life, it wasn't until 2 weeks ago that I tried to commit suicide. [Show More]I started taking Topimax 3 months ago for severe migranes. What a miracle drug!!! It cured my migranes unlike any other medication I had ever tried and there were many...Now I am almost weened off of the drug because I experienced, and still are, bad bad bad depression. Although I have suffered from chronic depression my entire life, it wasn't until 2 weeks ago that I tried to commit suicide. I hope that some day this drug is off the market. What ever happened to the black-box warning label on the med stating that it may trigger suicidal thoughts?
JessicaMarch 8, 2010 at 10:50 am
Ok, I can't believe this. I would have that with my history of bi-polar I would have gotten a worning about this drug from either my neurologist of my psychiatrist. Nope, now 2 suicide attempts later. I find out it could be due to this drug. I'm pretty upset, not only that i'm experiencing other side effects that i'm finding out are from this drug, and its noyt even helping my seizures.
TheresaMarch 5, 2010 at 9:48 pm
I was put on topomax for knee and neck pain by pain management. I have had hep C and I've had kidney stones 5x in my life. There was no counceling about side effects when prescribed. Except i was told that weight loss was a side effect. Being 220lbs at 5'1" at 43yrs old this sounded good to me. I first had the fingertip tingeling numbness and my dose was increased then there seemed to be no sympto[Show More]I was put on topomax for knee and neck pain by pain management. I have had hep C and I've had kidney stones 5x in my life. There was no counceling about side effects when prescribed. Except i was told that weight loss was a side effect. Being 220lbs at 5'1" at 43yrs old this sounded good to me. I first had the fingertip tingeling numbness and my dose was increased then there seemed to be no symptoms within 1 year I had lost 80lbs. That year was insane hell. I suffered a kidney blockage, needed a stent for 3 months Pain management and my neurologist both said to continue taking it, so I did. a few months after the stent I began having extreme behavior, irratic and combative also insomnia, I really believed I was pre menapausal. After a thoural exzam by my G.P. and O.B.G.Y.N I found it to not be pre menapausal. The behaviors continued and my eyesight began toget worse my eye prescription doubled along with my vision. I was frinally begining to think about the topomax, reading web postings and found all my symptoms including confusion and that loss of words thing. By then i was obsessed with my weight on the scale atleast 2x a daysometimes more. I knew i had to stop taking it and even lied to my loved ones saying i had stopped when i hadn't. I fell into extreme depression and then about 2 mth's later i was completely off it. It has been almoast 3 months now and my eyesight is still worse, and my mind feels broken.
LindalFebruary 15, 2010 at 1:29 am
Tegratol gave me terriable hallucinations I have 3 kids my youngest was a baby att (2yrs ago) I had to stay at Mum for months her and my partner had to shower and feed me I was liveless and hallucinating the neuro changed me to epilem I became suicidal. Topomax is the one that responds right with me
FrancesFebruary 13, 2010 at 4:01 am
I was places on Topmaxin 2008 for migraines that put me in drip dpression and suicide attemp, blurr vision seeing word . insomia can't sleep at all now or lest i take three medication now. I throught it was parted of my coniditoin. I started feel different
JoshuaNovember 24, 2009 at 5:30 pm
I was placed on Topamax in 2006 for migraines that were triggering seizures. I was taking 100mg twice a day for two years, During that time I attempted to take my own life 5 times, twice with a gun that misfired. My life was ruined. The High School I was attending (in 2007, I was a senior) sent me to a mental institution, and instead of letting me return to classes immediately, "suspended" me [Show More]I was placed on Topamax in 2006 for migraines that were triggering seizures. I was taking 100mg twice a day for two years, During that time I attempted to take my own life 5 times, twice with a gun that misfired. My life was ruined. The High School I was attending (in 2007, I was a senior) sent me to a mental institution, and instead of letting me return to classes immediately, "suspended" me for unconfirmed alleged rumors that I was sent off because of threats to shoot up the school. I now suffer with bipolar-like problems that affect my day-to-day life and memory. Is their anything that can be done for me?
richardNovember 24, 2009 at 12:30 am
7-1-06 my wife mother of 3 girls ended her on life . did topamax have any thing to do with this ?
ElizabethOctober 26, 2009 at 1:39 pm
I have deep concerns regarding the use of Topamax and young people. My son has Asperger's Disorder and was put on Topamax because of severe migraines that would trigger mild seizures. With in a very short time my son became very dark, and depressed. He had decided to commit suicide one night and it wasn't until we were at the crisis unit dealing with this that we found out that a child with As[Show More]I have deep concerns regarding the use of Topamax and young people. My son has Asperger's Disorder and was put on Topamax because of severe migraines that would trigger mild seizures. With in a very short time my son became very dark, and depressed. He had decided to commit suicide one night and it wasn't until we were at the crisis unit dealing with this that we found out that a child with Asperger's should never be on this drug because these kids are such global thinkers it was only a matter of time that it became too much for him and tried to take his life. He is not off the meds and getting councling. PLEASE BE VERY CAREFUL, this drug is DANGEROUS!
Epilepsy Drug Suicide Warnings Added by FDA : AboutLawsuits.comDecember 17, 2008 at 7:11 pm
[...] FDA officials originally indicated earlier this year that the medications should carry a “black box” warning about the suicide side effects of the epilepsy drugs, which would be the strongest warning that can be placed on a prescription medication. However, a panel of independent advisors to the FDA met in July 2008, and concluded that that a “black box” suicide warni[Show More][...] FDA officials originally indicated earlier this year that the medications should carry a “black box” warning about the suicide side effects of the epilepsy drugs, which would be the strongest warning that can be placed on a prescription medication. However, a panel of independent advisors to the FDA met in July 2008, and concluded that that a “black box” suicide warning was not appropriate. [...]
Topamax Lawsuits — AboutLawsuits.comJuly 23, 2008 at 5:36 pm
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