Fycompa Black Box

Discussion in 'Eisai' started by Anonymous, Feb 21, 2013 at 3:19 PM.

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  1. Anonymous

    Anonymous Guest

    Has anyone see the Fycompa label that includes a black box warning for homicidal ideation? Google it and it will pop up. How is the company going to spin that?
     

  2. Anonymous

    Anonymous Guest

    "Class Warning" is my bet
     
  3. Anonymous

    Anonymous Guest

    Spin? You don't spin a BBW, idiot. Also, the BBW is not for homicidal ideation. If you're part of our epilepsy sales force, god help us. But my bet is your a competitor who is getting scared. Well, I don't blame you. You have reason to be.
     
  4. Anonymous

    Anonymous Guest

    Read the BBW from the NIH government website
    http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=81828

    WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

    See full prescribing information for complete boxed warning.
    • Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA (5.1)
    • Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, particularly during the titration period and at higher doses (5.1)
    • FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening (5.1)
     
  5. Anonymous

    Anonymous Guest

    Sounds like Home office reponse above trying to mitigate the fact that yes there is a BBW and yes it does state homicidal ideation. I can read, looks like home office likes to read only happy words.
     
  6. Anonymous

    Anonymous Guest

    Literacy (or a grasp on reality) isn't a home office requirement.
     
  7. Anonymous

    Anonymous Guest

    Wrong on all counts. First, not that it matters, I'm not from the home office. Second, my post did not attempt to "mitigate" the fact that there is a BBW. Thirdly, my post never said that the BBW didn't mention homicidal ideation. What I was disputing, was the statement that the BBW is FOR homicidal ideation. The BBW is not FOR homicidal ideation. It is for Serious Psychiatric and Behavioral Reactions. Got it, dumbass?
     
  8. Anonymous

    Anonymous Guest

    Let's stop the word play. The words homicide in the BBW are pretty clear. The word "homicide my word parsing friend is the resounding echo that will resonate with anyone with half a brain who is reading the warning. Save the name calling it did not help your failed response.
     
  9. Anonymous

    Anonymous Guest

    First, you're right on the name calling, my bad. Happy to keep it above board. Regarding "word play" you're the one that needs to stop it. Again, assuming you're the OP, the BBW is not FOR homicidal ideation. If you're going to post regarding the BBW, try to be accurate in what you're talking about. Now, if you want to change the nature of your post (which is evidence that my post succeeded, BTW) and say that if someone reads the BBW the "resounding echo that will resonate" is the word homicidal, well, ok you have a point. But that's different from your original point that the BBW is FOR homicidal ideation. Again let's be accurate. BTW, there are other behaviors that are mentioned in the BBW, take a look. By your logic, someone could just as easily say that the BBW is for hostility.
     
  10. Anonymous

    Anonymous Guest

    Wow. I bet you are well liked among your team. Jerk.
     
  11. Anonymous

    Anonymous Guest

    Got emailed the PI today and took a look at this. The incidence is 3 patients in 4,368. That's a rate of .0007 or 7 hundreths of one percent. A doc would have to put 1,456 patients on the drug to see one case based on this rate. Also, keep in mind ideation is not the same as actually committing the act. Just my 2 cents.
     
  12. Anonymous

    Anonymous Guest

    Fycompa - it's killer!
     
  13. Anonymous

    Anonymous Guest

    Most of the drugs for epilepsy have a BBW. If you actually sold in this class, you would know that. This isn't new for those of us that do, nor does it worry us. This is a SERIOUS medical issue and the drugs that treat it are as serious. The benefits outweigh the risks and that's what it comes down to.
     
  14. Anonymous

    Anonymous Guest

    Amen!
     
  15. Anonymous

    Anonymous Guest

    yeah, a partial-seizure killer.
     
  16. Anonymous

    Anonymous Guest

    My girlfriend used to have 20 min orgasms but Fycompa stopped those - why isn't that in the warnings?
     
  17. Anonymous

    Anonymous Guest

    most drugs in this class don't carry a BBW. suicidal ideation is a class warning. some have issues with behavioral disturbances. only fycompa carries a warning about "homicidal ideation". not sure about you, but i can't think of many physicians who would want to prescribe a medication that had the slightest potential of homicidal behaviors. malpractice insurance is crazy enough without money hungry lawyers trying to excuse a murder on some doctors decision to prescribe a medicine with this warning clearly outlined in THE BLACK BOX. the other black box warnings are for birth defects and rashes. this one is for psychotic behavior. clearly, those who try to claim that "most" drugs in the epilepsy market have a black box warning, are hitting the kool aid a little too hard. read up on your competition before making uneducated statements.
     
  18. Anonymous

    Anonymous Guest

    you are an idiot. most antiepileptics don't have a bbw. you have been brainwashed by your company to sell this dog shit drug. the benefits of seizure reduction for the risk of manslaughter, i'm sure that totally outweighs the other.
     
  19. Anonymous

    Anonymous Guest

    You are so clearly NOT on the Epilepsy team, knowledgeable about the disease state or you would know that the rate is .1%. That's right - a tenth of a percent. This isn't weight loss - these are people suffering from life altering seizures. Neurontin is written for a million (off-label) uses and is tumorigenic, but it doesn't seem to stop the docs from writing it! Find something else to camp out about, because this isn't it.