July 15, 2008

The FDA Says No Black Box Needed On Drugs That Increase Suicidality, But Still Needed For Those That Don't



Yes, you read that right.  Drink a big glass of OJ and put away your blotter paper, you won't need 'em in here.



In a metanalysis of 199 studies covering 11 antiepileptics, the odds ration for suicidality was 1.80.

The first question that the committee had to decide was whether or not it agreed with the agency's overall finding of an increase in suicidality for the 11 AEDs that were analyzed.

The advisory committee, after much debate, determined unanimously, apart from 1 abstention, that yes, there is a signal that is statistically reliable.

Forget about whether these results are accurate or useful.  Just follow their logic: they believe their data.

The second question asked whether...the findings of increased suicidality should apply to all drugs included in the analyses, despite the observation that the estimate for the odds ratio for 3 of the drugs was below 1.

Remember science?  Remember classism?  Remember not blaming everyone in a group for the behavior of a few?  If the odds ratio is below one, then it doesn't have the risk.

The committee strongly agreed that the findings should apply to all drugs.

Awesome.  Faith in egalitarianism and the supremacy of science restored.

Well, all right, D- for interpretation of science.  They want to believe it causes suicide, so be it.

After this discussion, the committee members voted strongly against a black-box warning.

But I thought you guys said--?

One committee member pointed out the potential "hysteric reaction" that can accompany a black-box warning about suicidality. Other speakers emphasized the need to balance efficacy vs harm and commented that "in two-thirds of the trials this warning is irrelevant," "a black-box warning has a very negative connotation," and "the number needed to harm was 2 per 1000."

But then how do you possibly justify taking the box off drugs that show an increased risk, but leave the black box on drugs that have no such data?  Why does Seroquel get the warning-- no actual risk of suicide ever found, despite looking-- but antiepileptics don't, and they do have the data?

Other speakers also cautioned about diluting the effect of such a warning by widely implementing it.

Where's that rum?  Goddamn it, Mary, where'd you hide my rum?


---


Resulting in the inevitable.








Comments

I recognize that antiepilep... (Below threshold)

July 15, 2008 9:59 PM | Posted by Silver: | Reply

I recognize that antiepileptic drugs have significant cognitive effects in many people. Little did I know that this extended to the people who are reviewing the data, not just the people who actually take the drugs.

Including all of the drugs was just bizarre. On the other hand, putting the metabolic syndrome/T2DM warning on *all* the AAPs was kind of odd, too.

And - a "medication guide" to be distributed with the drugs. Were the panelists unaware that all patients already receive a long detailed list of potential adverse effects? Will this say anything different than the handout that comes at the pharmacy, or the information on the PI sheet? I'm looking at the pharmacy handout on Tegretol, and it helpfully tells me to call my doctor if I have new or worsening suicidal thoughts (and to use non-hormonal contraception, and to take folic acid and wear sunscreen. Nice guide.) I foresee lots of branded "medication guides" in the near future, now that pens are verboten.

When I first saw the news releases, my reaction was "Only 0.43% of patients with a seizure disorder, bipolar disorder, or chronic pain had some suicidal ideation in these studies? Really?" Even in my non-psych-diagnosed patients who I see for med adherence and behavior mod, the rate is rather higher than that.

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I'd like the safeguards ie ... (Below threshold)

July 16, 2008 6:44 AM | Posted by Diane Abus: | Reply

I'd like the safeguards ie the black boxes to remain in place.That they are there right on the box mitigates against zealousness in prescribing............

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The only black box induced ... (Below threshold)

July 16, 2008 11:12 AM | Posted by Doug Bremner: | Reply

The only black box induced hysterics will be coming from the pharma marketing people. They get more freaked about it than the patients. Smells like this argument about 'diluting' the message is coming from pharma marketing land. Phew!

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Antiepileptic drugs don’t g... (Below threshold)

July 16, 2008 6:08 PM | Posted by MattK: | Reply

Antiepileptic drugs don’t get the warning because they are used for just about everything a neurologist would treat, NOT just epilepsy...such as every type of chronic pain (and pain is BIG $$$). Those patients, thanks to CNN, would no longer let them throw those drugs at TTH, Migraine, or any neuralgia (Trigeminal, Occipital, Post Herpes, etc) like Brett Favre throws the ball to opposing teams in the 4th quarter. Oh, and the psychiatrists would have another drug that “causes" their patients to kill themselves. Since the Peripheral and Central Nervous System Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee are all likely neurologists and psychiatrists, they were not ready to be lynched by their colleagues who would then be pressed by patients to prescribe narcotics to treat pain as all antidepressants or antiepileptic could “make” the patient do something. And let’s not talk about NSAIDs… they are “not a real solution to pain. They can cause bleeding if taken long term.” And losing 20 points off of one’s IQ (Topamax) and sleeping a lot is a good solution to? Perhaps a loan to afford Lyrica? This leaves narcotics. As narcotics are EVIL, that wouldn’t be good. And what to do about those psychiatric patients that need to be augmented?

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My psychiatrist told me tha... (Below threshold)

July 20, 2008 11:09 PM | Posted by PolymorphicGirl: | Reply

My psychiatrist told me that he no longer trusts anything the FDA has to say because they have been bought out by the Republicans. Heheheh, he's a unique one.

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