Every drug has a LONG list of side effects (Annie calls it "the scandal sheet"), but this one's is more interesting than most:
"Serious or life-threatening psychiatric and
behavioral adverse reactions, including aggression, hostility, irritability,
anger, homicidal ideation and threats, have been reported in patients taking
FYCOMPA"
HOLY CRAP! Did I just read that correctly? Hmmm....
Let's look at the FDA's own information, as given in the manufacturer's filed paperwork:
Let's look at the FDA's own information, as given in the manufacturer's filed paperwork:
"... has summarized the narratives of 23 physical assaults, suicidal ideations, homicidal ideations, and damage to property in the Epilepsy and Nonepilepsy studies. Preferred terms included homicidal ideation, belligerence, aggression, affective disorder/psychotic disorder, personality change, irritability, aggression/impulse control disorder, anger, adjustment disorder, agitation, abnormal behavior, and personality disorder."
Now, with that said, I want to remind you that if you look at the side effects of ANY drug, you'll find scary shit on all of them. I'm sure I'll put patients on Fycompa, and most will likely do fine.
But still, I really like this line from the FDA forms:
"The Sponsor has reported that no homicides were committed by a subject while taking perampanel."
Wouldn't you just LOVE to be able to stand up in front of a government panel and say that with a straight face? "Yeah, I mean, there were a few people who became violent on our drug, but it's not like they killed anyone or something."
So with that backdrop, it falls to the marketing wizards to make this drug look good. Their job is to promote strengths and minimize weaknesses. So what image should they use to distract people from the side effect of violent behavior. Hmmm... Flowers? Butterflies? Or maybe...
A boxing glove! Yes, they really picked a boxing glove. I swear, I am not making this up.
And, since the glove is green, perhaps they should consider this spokesman:
"HULK TAKE FYCOMPA! MAKE HULK MAD!"*
*Hulk is copyrighted by Marvel Comics, along with the Avengers, Spider Man, Dr. Strange, the Fantastic Four, and a bunch of others I don't want to mess with. Or prescribe Fycompa to. **
**Thank you, SMOD, for the Hulk idea.
23 comments:
Sounds like a potential legal defence.
'My epilepsy medication made me homicidal'.
I would have thought turning patients into violent, enraged psychopaths would be one of those side effects that prevents the drug being approved by the FDA.
"I'm sure I'll put patients on Fycompa, and most will likely do fine" - Dr. Grumpy
YES, Dr. Grumpy, most of your patients on Fycompa will no doubt handle the new med without an issue.
Just watch your back with the ones who don't! :)
-EZ in TX
Apparently, Mrs. Cynical has been putting Fycompa in my breakfast cereal for about 10 years.
You're going to cause me to have a neurological disorder from all the head shaking I do reading your posts. This one was a doozy!
And the FDA has approved this drug? OkOk. My son is deaf and has cochlear implants which allow him to hear at a low normal level but he cannot wear them in the shower or while swimming, so when he is engaging in those activities he is profoundly deaf...he cannot even hear a jackhammer right next to him. I was looking at the cochlear webpage and I noticed they now have a cover that is basically an airtight small plastic bag that is the perfect shape and size to fit over the processor and it allows people to wear their processors while swimming in shallow water or in the shower. I thought GREAT! This is just what he needs, I'll be able to talk to him when we're at the pool in the summer. So, I called them up and tried to order one. No luck. It's only available in Canada because the FDA has not approved it for use in the United States. WTF? It's a piece of plastic!! You wear it while swimming and in the shower, you don't ingest it, it can't hurt anyone. Now, perhaps there might potentially be an issue if a very small child were to have one and put it into his or her mouth, but a very small child wouldn't be in the tub or pool alone anyway, so, nope, no issue. Why on earth they can approve this drug that causes people to possibly commit murder but they won't approve a plastic bag to cover a cochlear implant processor so people with implants can be safer in the pool, I just don't understand.
This sounds like levitiracetam on steroids. If Keppra induces Kepprage, what will Fycompa induce? Furycompa?
I hope it works well for some people. I don't think the NMDA antaonists were all that helpful for epilepsy patients; maybe AMPA antagonists will be better.
Please don't prescribe this drug!
curious if the mfg suggests informed consent process for this drug?
White4 Rabbit
Feed your head, feed your head.
Not to sick a severe case of black dog on anyone, I have been wondering if Adam Lanza was taking anything like this, I can't get that thought out of my head, but saw no such report of same. Sorry I can't shake it out.
people are crazy without drugs.
some drugs potentially make crazy people more crazy
cant wait until use of this one gets started in the headache circles...
"You wouldn't like me when I'm angry." - David Banner
Did the label say if it was more common for people taking the drug to have those thoughts than those taking a placebo? Unfortunately the FDA requires all potential adverse events to be put on the label regardless if they were more common on the drug or not. IE If in the clinical trial 1000 patients got the drug and 10 got migraines and 1000 patients got the placebo and 10 got migraines, the label will say that the drug may cause migraines even though it most likely doesn't.
"Welcome to my 'Murder Mystery Night' party. All of you got a glass of champagne when you came in. Every glass had a pill dissolved in it. One was Fycompa and the rest were placebos. Your job tonight is to figure out who the murderer is going to be before the pill kicks in."
at least there is a black box warning, and a patient medication guide for those willing to read it.
"Due to serious neuropsychiatric events (irritability, aggression, paranoia, anxiety), there will be a black box warning on the drug label alerting physicians about this risk. A patient medication guide will also be provided to patients."
Kim, I feel your pain about items not being approved in your country. Here I am in Canada, wishing we had Kapvay (slow-release clonidine) here for my son, but it's only available in the States.
Shoot....for me, those are all the side effects of having a migraine.
And I thought you surely made up the name of that medication. Fycompa??
For what it's worth, I'd be more willing to go on a ketogenic diet than try a medication with a side effect of making people homicidal, especially a maintenance med (as opposed to an emergency med taken in the hospital or once in a blue moon). Thanks, but no thanks.
Sounds like a "Law and Order" episode. It sounds beyond scary truthfully. Yes, the boxing glove is ironic and odd, but the Hulk is a great idea. Prescribe and wear a bullet proof vest.
wow, sounds like a drug should be called "fyc YOU!" hahaha
Hmmm...that side effect profile seems to match how I felt the many times I quit smoking cigarettes. I wonder if it affects the same receptors in the brain?
I sell this drug.
I have a mother with epilepsy. All drugs, as you stated, have seriously scary listed SE's that usually occur in a tiny percentage of patients who generally are on several other meds anyway.
For people with tonic clonic seizures, and those at risk of SUDEP, this drug could change their lives.
I absolutely agree with you.
And....we have zero say on the marketing campaign. Obviously!
I am now going to think of the hulk every time I see The Glove.
Great blog btw.
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