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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by SLS on May 9, 2009, at 6:18:57
"May 7, 2009 The US Food and Drug Administration (FDA) announced May 5 that it has approved new labeling for antiepileptic drugs to include a warning about an increased risk for suicidality with these agents. Manufacturers will be required to include a warning about an increased risk for suicidal thinking and behavior in treated patients and to develop a medication guide to provide information on this risk to patients prescribed these drugs."
Anti-epileptic drugs (AED):
* Carbamazepine (Carbatrol, Shire; Equetro, Validus; Tegretol, Tegretol XR, Novartis).
* Felbamate (Felbato, Meda Pharmaceuticals).
* Gabapentin (Neurontin, Pfizer).
* Lamotrigine (Lamictal, GlaxoSmithKline).
* Levetiracetam (Keppra, UCB).
* Oxcarbazepine (Trileptal, Novartis).
* Pregabalin (Lyrica, Pfizer).
* Tiagabine (Gabitril, Cephalon).
* Topiramate (Topamax, Ortho-McNeil Neurologics).
* Valproate (Depakote, Depakote ER, Depakene, Depacon, Abbott Laboratories).
* Zonisamide (Zonegran, Eisai).***********************************************
There is an ongoing debate regarding this action by the FDA that began over a year ago when the FDA first proposed that AEDs have a black box warning for suicide. Of course, the main argument against the FDA action is that too many people will decline to take potentially life-saving drugs for fear of the emergence of an adverse event for which there is still a paucity of data.
- Scott
Posted by Phillipa on May 9, 2009, at 11:39:13
In reply to FDA mandates suicide warning on AED labels, posted by SLS on May 9, 2009, at 6:18:57
Scott I read that one also. So seems like no meds are safe anymore. So what's your feeling on this? Phillipa
Posted by Jeroen on May 9, 2009, at 18:04:25
In reply to Re: FDA mandates suicide warning on AED labels » SLS, posted by Phillipa on May 9, 2009, at 11:39:13
i'm already a victim of this
not that i am going to do it, i am just thinking about it since i took lamictal for a week
Posted by Jeroen on May 9, 2009, at 18:11:29
In reply to i'm already a victim of this, posted by Jeroen on May 9, 2009, at 18:04:25
dont worry im in therapy (its not working very well)
i dont know what meds to take anymore since im resitant to Clozapine and its a really nasty drug makes you abnormal
Posted by yxibow on May 11, 2009, at 2:15:21
In reply to i'm already a victim of this, posted by Jeroen on May 9, 2009, at 18:04:25
> i'm already a victim of this
>
> not that i am going to do it, i am just thinking about it since i took lamictal for a weekA week of Lamictal is 25mg unless your doctors did something very wrong -- its titrated very slowly and I know you have belief that it did something to you, and I can't say anything much more other than it would scarcely enter a blood level of importance at that point.
Having thoughts about something and having concrete ideas are a number of things. Depression brings on thoughts, its natural.
I don't think its fair to yourself to say you're a victim of what the FDA is saying -- you are correlating things which may have no causation, and it certainly doesn't logically lead to the end of existence.I'm trying to be as polite about this, I understand you have been through a lot.
-- Jay
Posted by yxibow on May 11, 2009, at 2:27:04
In reply to Re: FDA mandates suicide warning on AED labels » SLS, posted by Phillipa on May 9, 2009, at 11:39:13
> Scott I read that one also. So seems like no meds are safe anymore. So what's your feeling on this? Phillipa
I think this was posted before, but yes, basically all medications that could be used potentially for mental health reasons will eventually have giant black boxes all over them.
It is, and I still say, *ss protection by some agreements between the FDA and drug manufacturers of all said above agents dating back 50 years.
I am sure there have been cases of suicide, I'm not negating them, but its the exact things of post hoc, ergo propter hoc that such as one of the Columbine killers happened to have Luvox in him therefore we should sue X manufacturer for 8 digit figures.
The crimes would have been commited if they also had breath mints in their system, with all due respect to the victims of this crime.
There were numerous other tantamount and viable reasons.
And yes, this could get to the point where drug trials are extended so long that nothing comes to market because people want cures and palliatives for something, but once it happens to cause a side effect, maim, or kill someone, then its off the market.Well, what do we have then ?
Because, and this is not an assault on the community but I see postings, what's new on the pipeline, Y drug has come out, this sounds great.
Then drug Y causes agranulocytosis in .09% of people who take it under certain circumstances and liver issues and then its the drug from hell.
Oh, don't get me wrong, I'm torn with having to take what I do, and I wish it could be downsized.
But there's no perfect or magic bullet -- everything has a side effect, including water. Drink too much of it and you die of electrolyte loss or kidney failure.
-- Jay
Posted by Jeroen on May 11, 2009, at 2:53:30
In reply to Re: i'm already a victim of this » Jeroen, posted by yxibow on May 11, 2009, at 2:15:21
hi anticonvulcants are known to cause psychosis in people at higher risk, you of all should know that
Posted by SLS on May 11, 2009, at 5:23:48
In reply to Re: FDA mandates suicide warning on AED labels » SLS, posted by Phillipa on May 9, 2009, at 11:39:13
> Scott I read that one also. So seems like no meds are safe anymore. So what's your feeling on this? Phillipa
I agree mostly with Jay. I think the incidence of suicide as a direct result of taking one these drugs is too rare to earn such a warning. Having said that, I would point out that Depakote has a tendency to make some people's depression somewhat worse. However, I still haven't seen this drug produce a suicidal state. With the antidepressants, I think that the application of a black box warning to every drug in this "class" is an alarmist, exaggerated gesture by the FDA, who has not proved its case against each drug individually.
The only warning that these drugs should carry on their labels is that they are too often used by irresponsible medical doctors who should be monitoring more closely the progress of their patients at least once a week during the first 6 weeks. I think a great many of us have had a drug make us feel significantly worse. For some people who are close to committing suicide to begin with, such drug reactions, if left unchecked, can be lethal.
- Scott
Posted by Phillipa on May 11, 2009, at 19:47:51
In reply to Re: FDA mandates suicide warning on AED labels, posted by SLS on May 11, 2009, at 5:23:48
Seems also that docs don't hospitalize patients who mention suicide. They just caution them and let them go. Guess the hospitals only take the ones who have already harmed themselves in some way. I remember when hospitalization was used just for med changes. Thing of the past. Phillipa
Posted by sowhysosad on May 11, 2009, at 21:25:21
In reply to Re: FDA mandates suicide warning on AED labels, posted by SLS on May 11, 2009, at 5:23:48
> The only warning that these drugs should carry on their labels is that they are too often used by irresponsible medical doctors who should be monitoring more closely the progress of their patients at least once a week during the first 6 weeks. I think a great many of us have had a drug make us feel significantly worse. For some people who are close to committing suicide to begin with, such drug reactions, if left unchecked, can be lethal.
Excellent point Scott. We all know that psych meds - particularly modern antidepressants - can increase suicidal thoughts through syndromes like akathisia and startup anxiety.
In the UK you're most likely to be given an SSRI or SNRI by a general practitioner rather than a pdoc, and they seem largely unaware of these issues. I've seen GP's umpteen times for AD's and not once have I been warned about the potential dangers.
Plus one (otherwise excellent on mental health) GP at my local surgery NEVER asks to reassess you after 2 weeks as guidelines dictate. Surely a recipe for disaster if anyone inexperienced with meds had a bad reaction.
Posted by yxibow on May 12, 2009, at 1:17:51
In reply to Re: FDA mandates suicide warning on AED labels » SLS, posted by Phillipa on May 11, 2009, at 19:47:51
> Seems also that docs don't hospitalize patients who mention suicide. They just caution them and let them go. Guess the hospitals only take the ones who have already harmed themselves in some way. I remember when hospitalization was used just for med changes. Thing of the past. Phillipa
Because there's no need to hospitalize someone who mentions thinking about suicide. Its a part of being depressed, among other diagnoses. There's a difference between ideation and true concrete plans.
The price of hospitalization for medication changes is so prohibitive it is scarcely used, you're right. Only under exceptional reasons would there be any advantage to it as opposed to outpatient clinics, even which are also not cheap.Hospital beds without anything else are in the low to mid four figures per day.
Even the homeless mentally ill that somehow end up in the hospital, often with multiple complications involving alcohol poisoning and the like, are discharged when the emergency is no longer there. That's a fact here I know and I'm sure in other parts of the country.
This however is not a blanket statement to anyone who has a true 911 emergency and not ongoing thoughts that do not cross that line. Its crass to say it but being here with us is better than a medical bill.
-- Jay
This is the end of the thread.
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