US Warns of Suicidal Actions With Epilepsy Drugs

[Halo]

US Warns of Suicidal Actions With Epilepsy Drugs

Thursday, Jan. 31, 2008; 4:28 PM

WASHINGTON (Reuters) - U.S. health officials alerted doctors on Thursday that medicines used to treat epilepsy and psychiatric disorders may raise the risk of suicidal thoughts and behavior.

The Food and Drug Administration said it analyzed studies of 11 epilepsy drugs including Pfizer Inc's Neurontin, Abbott Laboratories Inc's Depakote and Johnson & Johnson's Topamax. The studies included nearly 44,000 patients.

The analysis found patients treated with the drugs faced about twice the risk of suicidal thoughts or behavior compared to others who got a placebo.

The FDA estimated there were two more cases per every 1,000 patients given the drugs instead of a placebo.

About 0.4 percent of patients given the drugs reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients, the FDA said.

Four people who were taking one of the epilepsy drugs committed suicide, while none of the placebo patients did.

The agency said it expected the risk was shared by all anti-epileptic drugs and that changes to the drugs' prescribing instructions would be applied broadly throughout the class.

Officials at Pfizer, J&J and Abbott could not immediately be reached for comment.

 

[David Baxter PhD]

Comment:
Even assuming that this study can be replicated (the article doesn't how many patients were studied, how they were selected, what the droput rate was, how they decided who got to be in the placebo versus the medication group, or whether the study was double blind), note that according to the results the medications might increase the risk for suicide to 4 in a thousand instead of 2 in a thousand. We also don't know if there might be some reason why the drug group might have been more suicidal to begin with (for example, if the more seriously depressed or anxious patients, or those who had epilepsy, were placed in the medication group, that might explain the findings).

Either way, what this means is that 996 out of a thousand people taking these medications were NOT suicidal.

 

[Techie]

Of course... if even ONE person exhibits a 'symptom' or side-effect, it has to be reported... its always a tough call with prescribing drugs... but the article states that 4 COMPLETED suicide... not had suicidal thoughts... thats bad...

It stated that 44,000 people were in the study... 4 completed suicided. Thats like 0.00009 % ?? Im lousy with math but their stats dont make sense to me...

Well according to the stats we would expect 2 in 1000 to have suicidal tendencies... these drug creates a 100% increase in the potential suicide rate then ?? Again thats something to worry about is it not ? As such... it should be listed as a 'side-effect' so that prescribing doctors can be aware and watch for symptoms so it can be stopped if need be.

Again the article does NOT clearly say whether 4 in the study group or 4 people in the general public on the drugs committed suicide... but then says none of the placebo group did... it implies they were part of the study group. If so... then 100 percent increase is still very high.

I had to stop a drug because it caused suicidal tendencies... an Interferon drug for MS called AVONEX. I was one of the SMALL percentage that suffered 'severe suicidal thought processes' because of the drug. It lasted for two months... I went through HELL... so did my family... two weeks after I was off the drug... I was totally fine... but my MS has gone Secondary Progressive now... which really sucks big time can I tell you ! lol Its a big trade-off... do you accept the side effects for the benefits... with these more and more powerful drugs we have to understand there are NEGATIVES to each.

 

[David Baxter PhD]

Part of my point was that a statistic such as a "100% increase" has no meaning at all unless you know (1) what the true baseline is; and (2) characteristics of the subjects that may have caused this unrelated to the drug.

These so-called "epilepsy drugs" are used for a variety of purposes, including epilepsy, anxiety disorders, and depression/bipolar disorder (as a mood stabilizer). That third group, of course, has a greater rick for suicide than the first two and it may be that patients with epilepsy also have an increased risk. Unless we know the breakdown of the diagnostic groups in those taking the medication vs. those given placebo, again there is no way of evaluating the statistics reported.

And as for the fact that there were no completed suicides in the study group, if group assignment was not done entirely randomly, it is possible that those assigned to placebos (or those who remained in the palcebo group long enough to complete the study) were simply less ill, exhibited less severe symptoms than those in the drug group.

 

[Techie]

Exactly... thats what I mean about their stats confusing me...

I wonder what the chances of a 'normal' person then suffering the suicidal thoughts that the drug I was on would have had ? Again... and like you say... it would have to be so carefully planned and controlled to have the stats mean anything... I guess what I was saying... without making sense (lol) was that its nearly impossible to do that... so I guess we do need to include those stats for what we did see... just in case... play it safe... again as a guideline for prescribing docs to watch for.

Like me with the Avonex... I read the full drug specs... including the 'reported' side-effects. I read than in some 0.5 - 1 % there was a reported increase in severe suicidal behavior including completing suicide... when I 'encountered' that symptom myself... I could easily have dismissed that as being 'depressed' (as I was/am) and NOT attributed it to the drug. I waited it out... it got worse and said to my wife... help me keep a watch out as it is a possible side effect... it got SO bad my Neuro took me off the drug... within a few days I was better and within two weeks it was totally gone... and I was back to normal.

Without knowing this was a possible side effect... I would have assumed it was 'me' and just stayed on the drug never knowing.

In that case the benefit of the drug was NOT outweighed by the side effects.

Now... there could be whole debates as to... is it possible that people like me are more susceptible to those feeling because we are depressed or suicidal BEFORE taking the drug... etc. A valid question... but irrelevant in the overall scheme as the immediately easier solution was to just stop the drug and see what happened.

The need for the drug OUTWEIGHS the benefits for MOST people but my docs and me obviously needed to know that there was a SLIM chance this could happen so we could watch out for it.

Then there is this whole 'Matrix', 'Neo' thing with knocking over the vase in the Oracle's house... did me KNOWING that its a possible side effect MAKE me like that. Well again... its POSSIBLE... but I did not read the full drug details until after I was like that for a good month or so... thats when I went to my Neuro about it.

Oh... I am also on Tegretol (an epilepsy drug). In my case it might be (and probably would be) impossible to determine if the drug had any potential in increasing my suicidal thoughts.

Then again... if you did NOT have epilepsy... or MS... or depression (no pun intended) you would not NEED the drugs and therefore not be susceptible to the increased suicidal tendencies caused by it... as you would probably already suffer from depression, despair etc.

OK now that I read this over... I cant follow what I am saying MYSELF... lol I guess what I am saying is...

YES, the statistics dont mean anything really because its too complicated to prove one way or another.

Its better to list EVERY threat they 'encountered' during the trials JUST IN CASE... even if it was only one in a million, is it not ?

and finally: sometimes is better that we (patients) DONT know what side effects there may be !!

 

[Halo]

and finally: sometimes is better that we (patients) DONT know what side effects there may be !!

While I see your point on some of what you are saying, I completely disagree with what you said above. Being a patient I think that we absolutely have a right to know what the potential side effects are to any medication that we are putting into our bodies.

For instance, if I was to take one of the above mentioned medications and did not know that there was a potential side effect for suicidal thoughts and behaviours then I may assume that it was just my depression getting worse and may not be as likely to tell my doctor about it thinking that the medication is not working. Now if I know about the potential side effects then I realize that if I start to have suicidal thoughts and behaviours I can bring it up to my doctor and discuss the course of action to take.

Looking at this from another perspective, what about other medications such as diabetic, heart and high blood pressure medications. What about the possible side effects to those medications? Would you still agree that a patient shouldn't know the potential side effects of the medication they are taking?

 

[David Baxter PhD]

You make some good points, techie.

I'm reminded of the issue of immunizations. When I was a child, everyone was vaccinated against smallpox. ¹

When my children were small, at some point I realized they weren't getting smallpox vaccinations. When I asked my doctor about that, he explained that the incidence of smallpox in the world and therefore the risk of contracting the disease was now so small that it was lower than the risk of an adverse reaction to the vaccine.

It's all about a risks-benefits analysis...



¹ I think it was smallpox... if not, one of the things we all used to be vaccinated against and now no longer are...

 

[lallieth]

I generally want to know the side effects of any medication I am taking.However there are some doctors that poo poo the whole idea of side effects,saying that the good of the medication outweighs any side effects

While in most cases this may be true,why take a medication that may potentially cause a very serious adverse reaction,when there may be an alternative medication

As Dr Baxter pointed out the small pox scenario,it reminds me of the chicken pox vaccine..While there may be a potential for secondary adverse reactions in getting the chicken pox,these reactions remain rare and I see no need for a chickenpox vaccine

Millions of kids have had chickenpox with no secondary problems,which leads me to believe the media feels the need to over dramatize most situations,which gets the public into a fear frenzy,potentially leading to untreated illness's for fear of the medications.

 

[David Baxter PhD]

Suicidality and drugs

Suicidality and drugs
The Trouble with Spikol

I have been woefully inadequate in paying attention to Furious Seasons, but today there's an interesting post on a new FDA warning about suicidal ideation, etc., in relation to Lamictal and Topomax. You can get all the pertinent info from Dawdy, as usual, but he writes:

It's not clear to me what the implications are for treatment with these drugs in bipolar disorder, but they cannot be very good. In coverage by the New York Times, doctors stressed that the benefits of these drugs outweighed the risks both in treating bipolar disorder and epilepsy. But the more important question is what patients think--doctors sometimes forget that it's patients' butts that are on the line--and how they respond to the warning. Obviously, people diagnosed with epilepsy don't have a lot of options for controlling seizures. Aside from Lithium, patients with bipolar disorder don't have many options either.

As a patient who is on both Lamictal and Topomax, I feel I can speak to Dawdy's questions. For me, Lamictal has been an absolute lifesaver. My breakthrough magic-bullet medication cocktail has been Seroquel and Lamictal, with other stuff thrown in as needed. Lamictal keeps my mood even, while the Seroquel keeps the psychosis at bay. Without the Lamictal, I cycle ... unpleasantly, to put it mildly. At this point in my treatment, I would never consider going off of it. In fact, anticonvulsants have been extremely effective in controlling my mood symptoms, but I struggled for a long time with side effects. I no longer suffer from any side effects from the Lamictal, though I know from Dawdy's post that the initial stages of treatment are apparently quite risky. That being said, I worry sometimes about villifying medications that can benefit people. What if I had seen a warning and decided not to try a drug that has truly saved my life? Just had to put that out there.

I take the Topomax for migraines, and I've gone from a migraine a day to about two a month. It's been incredible. But I have no opinion on it for psychiatric concerns. The main side effect for me has been loss of appetite and resultant weight loss, and I'm ashamed to say that I've enjoyed that side effect. I've only been taking the Topomax for about six months, but lordy, I'm glad those headaches have diminished.

 

[Techie]

I generally want to know the side effects of any medication I am taking.However there are some doctors that poo poo the whole idea of side effects,saying that the good of the medication outweighs any side effects

While in most cases this may be true,why take a medication that may potentially cause a very serious adverse reaction,when there may be an alternative medication

As Dr Baxter pointed out the small pox scenario,it reminds me of the chicken pox vaccine..While there may be a potential for secondary adverse reactions in getting the chicken pox,these reactions remain rare and I see no need for a chickenpox vaccine

Millions of kids have had chickenpox with no secondary problems,which leads me to believe the media feels the need to over dramatize most situations,which gets the public into a fear frenzy,potentially leading to untreated illness's for fear of the medications.

You want to know something funny (strange funny) ? My son... has had chickenpox THREE separate times - over a year apart. CONFIRMED each time with blood tests (not antibody test but active virus) AND he was vaccinated at an early age (about 6 months before his first case)... how's that ?? Each time... the case he had was WORSE than the case before. Our doctor cant explain it.

 

[Daniel E.]

Millions of kids have had chickenpox with no secondary problems

Yeah, but a cosmetic issue would be facial scarring.