Comments: FDA Orders Suicide Warning For Bipolar, Epilepsy Drugs
Okay, let me get this straight, one of the main justifications for giving people with psych labels these drugs is suicide prevention but the drugs "increase suicidal thoughts or behavior." Maybe we can get Dguller and Goodwin to point out that even though the drugs increase suicidal thoughts or behavior the drugs decrease suicide, but it seems unlikely. Also the statement is poorly worded. I doubt that you can have suicidal behavior unaccompanied by suicidal thoughts but again I could be wrong. It seems like they probably meant suicidal thoughts sometimes leading to suicidal behavior. And I wonder if completed suicide is included in their use of the term suicidal behavior, probably, but again, it could be dguller and Goodwin's suicidal gestures only.
Posted by Sally at December 16, 2008 12:43 PM
In January 2008, the FDA alerted healthcare professionals, In December 2008, the public.
Did anyone here taking any of these drugs after January, get this new information from their doctors? (Please note who this question is addressed to. I'm not interesed in a Psychiatrists point of view)
Posted by Becky at December 17, 2008 04:22 AM
Well, you can always knock me over with a feather when the FDA does anything positive in the direction of drug safety. My daughter's "very jolly" shrink, proudly announcing he was on a "Glaxo Lamictal Board", started her off on Lamictal slowly as indicated for bipolar depression. And slowly the suicidality built. She was incapacitated by it. I had to live with her, and all the knives left the house, as "cutting" became an obsession. Major hormonal problems erupted and made it worse. After several months of terror, she had to be hospitalized to taper down safely. Medwatch was as usual a crock - told ME to tell the company. The company sent me a little questionnaire. This was three years ago, and one of many psyc drug disasters that have ripped our family to shreds.
As for D. Guller, he would be well to avoid trying to contact me, for I have nothing to say to the likes of him.
Posted by Sorrowful at December 17, 2008 09:02 AM
Point of info: you can subscribe to the FDA alert and notice listserve. I am on this. Mostly, the notices are uninteresting or irrelevant, so I just delete them. Like: some batch of some pharmaceutical had some quality control problem and is recalled. I get a few a week; sometimes 2-3 in one day. So no great email burden. But you will see these black box warnings as they become official.
https://service.govdelivery.com/service/user.html?code=USFDA
Posted by MedsVsTherapy at December 18, 2008 07:55 AM
Maybe it's just the fact that a drug that has basically worked miracles for me now has a black box warning, but where does the genuine medical warning end and where does an ideological argument against psychiatric drug use begin?
I know the mechanism in virtually all of these drugs: the med increases one's ability to act before it increases one's mood, putting one in a dangerous, possibly agitated place during that "twilight zone" before (if the drugs work for a person, of course; I realize they don't always) their mood improves as well.
All psychiatric drugs, particularly when one starts them, need to be monitored FAR more closely then they are now. And one would think that, if these biochemistry researchers are the geniuses they claim to be, they could tweak depression meds to eliminate the "danger zone" of agitation, and equalize the effect on action and on mood.
But for now, if monitoring helps people get through the "danger zone," and the drug then works for someone, how exactly is that worse than not taking the drug and staying exactly where they are -- in deep depression?
Posted by Larry at December 22, 2008 10:28 AM
"I know the mechanism in virtually all of these drugs: the med increases one's ability to act before it increases one's mood, putting one in a dangerous, possibly agitated place during that "twilight zone" before (if the drugs work for a person, of course; I realize they don't always) their mood improves as well."
sorry but that is just a PR line of BullSh*t. How can you apply this when there are people who take these meds for conditions that have nothing to do with depression? (like SSRIs for hot flashes, anxiety etc., or epilepsy drugs for, well epilepsy?)
If that was the case then people without depression and without any suicidal thoughts or anywhere near that, for them taking these medications tbey wouldn't end up feeling suddenly suicidal and even acting on it because "now they have the "energy" (HA! yeah right!) to act on these thoughts" - that they NEVER had befor!
There is obviously just something about these drugs that are made to mess with the way a persons brain is functioning that can lead to a person just going over the flipping edge. It's not that they can now "act" (like 99% of depressed people who take these meds can't function AT ALL until they take the meds? where befor they were COMPLETELY paralyzed (catatonic) to the point where they couldn't make the effort to swallow an overdose of pills ??? (Hello they can take the damn antidepressant pills to get better, so I am sure if they were suicidal befor it wouldn't be impossible to take an overdose then, or load a gun, or tie a noose etc.)
This "explanation" is just such a bunch of bullshit. I am sorry but if you believe it then you obviously haven't put much thought into the matter (I'm not trying to be insulting, it's just true) because there is a LOT more going on here than just depressed people getting the energy to finaly off themselves (how sad it is that the devastating life ending effects these drugs can have is put off onto the very disease they are meant to treat and once again the patient is blamed and loved ones are left thinking "oh so and so must have really been thinking about killing themselves for a long time, they just didn't have the energy to do it until this medication started "helping" them.")WTF? Once again a great example of psychiatry and psychiatric treatment blaming the illness and the patient for IT's short comings and dangerous "side effects".
Mental illness makes such a good "fall guy" for the industry it's no wonder they get away with so much... I mean how can you not blame the crazy person for doing crazy things? How could it ever be the meds that were suppossed to help? But the real crazy thing is that now, as these drugs are marketted and pushed to be used for more and more non-mental illness uses, and now that there are people who are not "crazy" but are now doing crazy things once they've been put on these meds,... well it is sort of insane for these companies to think that people will continue to buy thier bullshit "blame the patient/illness" explaniations of these adverse effects and events and to continue on with the same line of bull.
They are so damn greedy, and they know all to well they'll always make more money from selling thier drugs, not warning people of the risks, harming people and then settling the lawsuites then if they admitted what they know about how these drugs can and DO effect a certain subset of the patients taking them and people wised up and stopped turning to psych meds for every little temporary blip in thier life and inconvienient behavior. And so they are now trying to find new diseases (NOT mental illness related) to treat with thier drugs to get a bigger market share and they are so greedy, and so corrupt that even though they know that by doing this they are exposing themselves to have the truth found out (because when not-crazy people start doing crazy things after starting a psych med it's hard to argue that it's thier pre-existing insanity that made them do it) ... well anyways, they don't even care that they are going to expose themselves to new lawsuites this way because they STILL are going to make more money in the end than what they can get sued for.
Seriously, the awards when people win a class action, or a personal lawsuit against these companies (for lieing about thier known-by-the-company side effects and adverse effects) should be in the BILLIONS of dollars. THAT is the ONLY way we will EVER get the drug comps to be honest ahead of time about the dangers of thier meds because as you can see from thier recent self exposing marketting choices, they just don't care about lawsuits that take hundreds of millions of dollars from them. What's that to a company that makes 4 billion off of one med in just a few years time? it's peanutts.
Posted by katielou82 at December 26, 2008 03:24 PM
Katielou:
I think you misunderstood my point, and certainly willfully twisted my motives.
I have two suicide attempts in my past myself, at least one of which was likely the result of an activating mechanism of a new medication. I am not trying to excuse the drug companies (in fact, I think I said it's time they got off their d*mn @$$ and fixed the biochemical problem), just trying to explain the phenomenon.
Having a suit upheld for, say, $1 trillion in a court in Mississippi or Alabama (which could easily happen) would mean the tens of millions in the U.S. and hundreds of millions around the world who depend on life-saving medication -- and not just for depression -- couldn't get it, or at least could only get it with great disruption, which in some cases would mean the same thing.
If you think (as many do, certainly on FS), for all the terrible side effects and horror stories seen on these pages and elsewhere, that this would be a better world if psychiatric medication was in effect banned in the United States, I shudder.
Posted by Larry at December 27, 2008 09:21 AM
My mother had bipolar disorder & committed suicide after many attempts when I was a teenager in 1970 before all these meds were introduced. Mental illnesses cause people to kill themselves often. That has to be addressed.
I seem to have inherited her mental illness & also have attempted suicide (1st time at 15). I finally got RELIEF from the suicidal depressions when I was put on Lamictal & Abilify 10 years ago. My doctor has kept very close contact with me. I have her cell phone # & saw her weekly while getting up to therapeutic dosages slowly.
I also do individual therapy & dialectical behavioral therapy weekly which are very helpful.
I read all the warnings & discussed them with my doctor. These kinds of warnings also appear on medications I've had to take for a back injury & other conditions. EVERY medication carry risks & need to be considered carefully. Considering my past suicidal behaviors these medications have been a lifesaver (literally) for me.
Posted by S.G. at January 30, 2009 12:54 PM
As of 3/21/2009: the last Labeling Revision for Lamictal was 9/25/2006. How long do the manufacturers have to comply with the REQUIREMENT?
To find the updated FDA alert from 12/16/08, which includes: "all manufacturers of drugs in this class are required to include a Warning AND develop a Medication Guide..." You must do a search for Lamictal (not generic, nothing there), click on "Other Important Information from FDA" which brings up the 1/31/08 alert, THEN click on "More information" at the end.
You would think ALERTS important enough for new REQUIREMENTS for WARNINGS and creation of MEDICATION GUIDELINES for patients, would be easier to find.
Posted by Becky at March 21, 2009 09:17 AM