DF Logo

Welcome Guest ( Log In | Register )

Advertisement


 
Reply to this topicStart new topic
>  Fda Says No To "black Box" On Anti-convulsants, Suicide warning rejected by FDA for Epilepsy Drugs | Add To Bookmarks
Advertisement
Advertisement
samblank
post Jul 13 2008, 02:38 PM
Post #1


Member
***


Group: Member
Posts: 173
Joined: 24-January 07
From: Ohio
Member No.: 13,526




Read this on Google News

In January, the US Food and Drug Administration (FDA) began the process of evaluating 199 studies of anti-seizure drugs commonly prescribed for epilepsy and other disorders due to reports of suicidal behaviors in patients taking them. Their findings led them to request a black-box warning be placed on the prescription labels of all 11 drugs under evaluation because the risk of suicide doubled when taking these drugs. The findings of the FDA evaluation were presented for discussion to a 20-member panel of advisers who voted unanimously on Thursday to deny the request for the black-box warning.

A black-box warning is the strongest warning of danger available to the pharmaceutical industry. Instead, the panel approved sending medication guides to physicians that describe the increased risk of suicide posed by these medications.

The panel said the risk of suicide wasn’t high enough to warrant the black-box warning and that to allow it might deter physicians from prescribing it. The opinion of the panel is taken very seriously by the FDA and the agency usually follows its recommendations.

The drugs in question include both the brand name and the generic name of Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate, Gabapentin (Neurontin), Lamotrigine (Lamictal), Levetiracetam (Keppra), Oxcarbazepine (Trileptal), Pregabalin (Lyrica), Tiagabine (Gabitril), Topiramate (Topamax), Valproate (Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (Zonegran). These drugs are often prescribed to treat epilepsy, migraine headaches, bipolar disorder, and several other conditions.

While the FDA does not think there is reason to alter or interrupt treatment if a patient is taking any of these medications, they do advise caregivers to pay special attention to changes in mood, behavior, and the actions of the individual patient.


I have taken three of the above mentioned drugs for many years. I always wondered about the side-effects. I know that a lot of anti-convulsants are used to treat depression. It seems counter- intuitive.


--------------------
Sam

"I am not discouraged, because every wrong attempt discarded is another step forward." Thomas Edison

Chief: Are you thinking what I'm thinking ?
Maxwell Smart: No Chief, I'm thinking what I'm thinking.



Go to the top of the page
 
+Quote Post

Always Trying
post Jul 13 2008, 04:04 PM
Post #2


Moderator
Group Icon


Group: Admin Team-Moderator
Posts: 820
Joined: 27-October 06
From: Williston, VT
Member No.: 11,168




While you give us a very thorough recap of a very important topic, I'm not sure I understand what you are really saying by this being counter-intuitive. Probably because I don't have the level of intelligence that you do! Anyway - I take Lamictal. My doctor did tell me at the start some of the most typical side effects, that should these appear for me, to contact her immediately. After a year, I have not had one single side effect.

When we discussed this drug, I brought up some of the negative side effects that I had heard of in general life. She made clear that it is unfortunate that the negatives are so widely disclosed, as it does an injustice to the particular drug. Only a slight few have those negatives. And if they report these to their doc, these can be addressed immediately so that there are not serious repercussions. I feel that in life, sometimes you have to trust just one particular person, so that you don't go nuts trying to make sense of all the differences in thoughts. I have always felt that her particular strength lies in medication.

I know nothing about epilepsy. I can relate to every other disorder you name. My only conclusion to what you say, is that if a person with epilepsy and or depression, is taking both an anti-depressant along with the drugs you state, that there certainly has to be a good reason for that. The levels of severity for both disorders makes a huge difference on the course of treatment. Also, what I feel to be the biggest factor is simply what we don't know about the person who takes these. Unless we spoke with their doctor, we don't know and shouldn't judge.

When you say that you have wondered about the side effects of your drugs, by virtue of your taking these for many years, the obvious conclusion is that you do not suffer from any of the possible negatives. Lucky You! But if you are just curious as to what the side affects are, you can go onto the drug manufacturer's sites to read the specifics of more than you want to know. Also, I have been advised many times to not read that info, due to the power of suggestion, and the estimations of the results are out of context. If someone was to believe everything they read, then it's probable that everyone would be dead from any med they take. The bottom line is that if someone is experiencing a negative side effect and or it outweighs the intended help of the med, or they simply cannot tolerate the negative, then certainly they should contact their doctor. One person's level of tolerance is different from somone else's. Now that I think about it, to me this discussion is as pointless as two people talking about their income taxes. One saying they are getting a huge refund and the other not getting that, and they think their incomes are comparable. There is so much that is not known from these two that if they were to view each others tax return, then their distress would be eliminated. So that subject simply isn't worth comparing. Maybe this is a bad analysis, if so please let me know. As I said, my level of intelligence isn't even close to yours.

Thanks for bringing up a topic that is worthy of everyone's consideration.



--------------------
Always Trying

In everyone's life, at some time, our inner fire goes out.
It is then burst into flame by an encounter with another human being.
We should all be thankful for those people who rekindle the inner spirit.

Albert Schweitzer

Go to the top of the page
 
+Quote Post

moonlightress
post Jul 14 2008, 08:21 AM
Post #3


Silver Member
******


Group: Silver Member
Posts: 950
Joined: 19-March 08
Member No.: 23,704




QUOTE (samblank @ Jul 13 2008, 09:38 PM) *
I have taken three of the above mentioned drugs for many years. I always wondered about the side-effects. I know that a lot of anti-convulsants are used to treat depression. It seems counter- intuitive.

Interesting article! It tallies with much of my own experience. I have to wonder, though, if the suicide rate hasn't doubled because it is increasingly being prescribed for mood disorders where there IS a higher suicide rate than in epilepsy?

I started a topic somewhere else on DF about mood stabilisers precipitating a depressive episode. I've been on lithium, carbamazepine and Topamax in the past, and all three of these plunged me back into the depression I was being treated for. I remember being suicidal on both lithium and carbamazepine; both of them landed me in hospital. I caught the Topamax depression before it got too deep, and stopped taking it. It didn't seem to be common experience here on DF. But I'm glad the FDA decided, at least, to send med guidelines to docs about this, so they know to look out for it, even if it didn't warrant a black box - because I am one case where it happened.

Now, however, I'm taking Lamictal and it DOESN'T seem to have made me more depressed. How is that for counter-intuitive...? (I don't think I'll ever understand my brain...) I think using anti-epileptics for depression seems counter-intuitive because many of these anti-epileptics do the opposite of what ADs do, so why would they be used in depression? But I would bet they are used far more in Bipolar where there IS a need to modulate the AD effect. (Lamictal seems different since it also seems to have an AD effect).

It just goes to illustrate what Always Trying said, about everyone having different responses and that it is almost impossible to predict how someone will react to a particular med. I was really worried about the Lamictal, but it turned out fine and Lamictal seems to be known for a low SE profile, which was true for me.

Just wanted to put up my hand and say Yup, it happened to me.
Go to the top of the page
 
+Quote Post

Always Trying
post Jul 14 2008, 11:45 PM
Post #4


Moderator
Group Icon


Group: Admin Team-Moderator
Posts: 820
Joined: 27-October 06
From: Williston, VT
Member No.: 11,168




Moonlightress,

I need to thank you for your postive plug that you referenced from my post. However, it is crystal clear to me that I am not in either your league or samblank's. I KNOW I don't hold a candle to your level of smarts, so I am very glad you joined in on this topic so others can focus on your reply and hopefully not look at mine!
I am always thankful that you are a member in this forum!


--------------------
Always Trying

In everyone's life, at some time, our inner fire goes out.
It is then burst into flame by an encounter with another human being.
We should all be thankful for those people who rekindle the inner spirit.

Albert Schweitzer

Go to the top of the page
 
+Quote Post

moonlightress
post Jul 15 2008, 02:49 AM
Post #5


Silver Member
******


Group: Silver Member
Posts: 950
Joined: 19-March 08
Member No.: 23,704




Oh, AT.....
You're not running yourself down, are you...? unsure.gif
I'm also grateful that you're here!

This post has been edited by moonlightress: Jul 15 2008, 02:51 AM
Go to the top of the page
 
+Quote Post

joey
post Sep 20 2008, 02:34 AM
Post #6


Junior Member
**


Group: Junior Member
Posts: 114
Joined: 17-September 08
From: Karratha, Western Australia
Member No.: 28,883




I was diagnosed with epilepsy when I was 12. It was partial complex seizures from scarring on the right temporal lobe my brain surgeon told me.
From my personal experience with anti-convulsants, Tegretol, Sabril (vigabantrin, wasn't approved in the USA) and Keppra were the ones that caused severe mood swings and depression. I am still on Keppra.
Epilim and Lamictal improved my mood but didn't control the seizures enough. I'm still on Lamictal as well.

I was never asked about depression side-effects of the medication from any doctor. I told my specialist that I was feeling down from the Keppra when in fact I was sometimes feeling suicidal. He was only interested in total seizure control which is fair enough but I have to live with these feelings. It's pretty bad that it's taken over 20 years to have this problem addressed. Should I have visibly fallen apart earlier? veryangry.gif
Go to the top of the page
 
+Quote Post

moonlightress
post Sep 20 2008, 11:47 PM
Post #7


Silver Member
******


Group: Silver Member
Posts: 950
Joined: 19-March 08
Member No.: 23,704




QUOTE (joey @ Sep 20 2008, 09:34 AM) *
I was never asked about depression side-effects of the medication from any doctor. I told my specialist that I was feeling down from the Keppra when in fact I was sometimes feeling suicidal. He was only interested in total seizure control which is fair enough but I have to live with these feelings. It's pretty bad that it's taken over 20 years to have this problem addressed. Should I have visibly fallen apart earlier? veryangry.gif

Hi Joey
There's no reason why you shouldn't be able to be treated for both epilepsy and for depression, but yes, you have to speak up and say you feel suicide seems like a good option - hopefully then s/he will see the severity of your depression. (Having suicidal thought is an indicator of severe depression.) Hope the specialist you see is a psychiatrist? If he's a neurologist, try to ask if he won't send you to a psychiatrist for evaluation...? then the two of them could co-ordinate your treatment.

Lamictal is working for me, in combination with some ADs and an AP. I'm not epileptic though, I'm bipolar.
Go to the top of the page
 
+Quote Post

joey
post Sep 21 2008, 04:59 AM
Post #8


Junior Member
**


Group: Junior Member
Posts: 114
Joined: 17-September 08
From: Karratha, Western Australia
Member No.: 28,883




QUOTE (moonlightress @ Sep 21 2008, 12:47 PM) *
Hi Joey
There's no reason why you shouldn't be able to be treated for both epilepsy and for depression, but yes, you have to speak up and say you feel suicide seems like a good option - hopefully then s/he will see the severity of your depression. (Having suicidal thought is an indicator of severe depression.) Hope the specialist you see is a psychiatrist? If he's a neurologist, try to ask if he won't send you to a psychiatrist for evaluation...? then the two of them could co-ordinate your treatment.

Lamictal is working for me, in combination with some ADs and an AP. I'm not epileptic though, I'm bipolar.



I last saw that neurologist in 2005 just before we moved cities. I have always tried to tough out my mood swings and depression because I was scared of even more drugs in my system. The GP in the small town that we've just moved to this year was the first doctor to put me on an antidepressant. I had told other neurologists in the past and they weren't at all interested in how I felt- only complete seizure control. It's like walking on a tightrope.
Go to the top of the page
 
+Quote Post

moonlightress
post Sep 21 2008, 12:20 PM
Post #9


Silver Member
******


Group: Silver Member
Posts: 950
Joined: 19-March 08
Member No.: 23,704




QUOTE (joey @ Sep 21 2008, 11:59 AM) *
It's like walking on a tightrope.

Nodding.... I had the same problem when Efexor shot up my blood pressure. My psychiatrist consulted with a psychopharmacologist and a cardiologist and then he said - "typically, each specialist is most worried about their own field!". The psychopharmacologist said "keep the Efexor and just treat her blood pressure' and the cardiologist said "stop the Efexor if it's causing high blood pressure. (We settled for the former!!)

So you'd need a combination neuro - psychiatrist. Or two who work together. Or even better, a psychopharmacologist, who would have a good knowledge of both epilepsy and depression. I also live in a small town and have to travel to the nearest city, 1.5 hours away to go to the psychiatrist and for therapy. Perhaps you can find a specialist in a nearby town, who will agree to work with your GP?

Since some anti-epileptics are used as mood stabilisers and some (like Lamictal,) have some AD effects, surely something can be found....
Go to the top of the page
 
+Quote Post

joey
post Sep 21 2008, 08:10 PM
Post #10


Junior Member
**


Group: Junior Member
Posts: 114
Joined: 17-September 08
From: Karratha, Western Australia
Member No.: 28,883




QUOTE (moonlightress @ Sep 22 2008, 01:20 AM) *
I also live in a small town and have to travel to the nearest city, 1.5 hours away to go to the psychiatrist and for therapy. Perhaps you can find a specialist in a nearby town, who will agree to work with your GP?


The nearest town that would have a specialist is the capital city Perth, and that is 1500 kms away. This is a massive state. I am overall feeling better now thanks to the Lamictal + Cipramil to balance out the Keppra. I still have to monitor my moods a bit though.
Go to the top of the page
 
+Quote Post


Reply to this topicStart new topic
1 User(s) are reading this topic (1 Guests and 0 Anonymous Users)
0 Members:


 

RSS Lo-Fi Version Time is now: 9th January 2009 - 05:44 PM