FDA Warnings on Anti-Depressants for Teens Cause Serious Side Effects

The black box warning is the strongest statement the Food and Drug Administration (FDA) can require a drug company to issue. It is reserved for cases of serious or life threatening side effects. So it was a big deal in 2004 when the FDA forced drug companies to add a such a warning about increased suicidal thoughts in teens to a wide variety of antidepressants. The move was in response to some highly publicized 2003 findings about Paxil, one popular antidepressant.

That warning caused a dramatic drop in anti-depressant use by teenagers—20 to 30 percent. The results, according to a new working paper from the National Bureau of Economic Research:

Teen suicides increased:

Youth suicides had been flat or declining among 10-19 year olds in the years preceding the warnings, but in 2004, 10-19 year old girls experienced a sharp increase in suicides, of over 30 percent. 

Depressed teens, primarily girls, experienced a drop in their grades, opening up an achievement gap between depressed and non-depressed teens that didn't exist before the warnings:

We find that in 2002 and 2003 adolescents with probable depression had grade point averages .14 to .20 points higher than adolescents with depression in the latter half of 2004 and 2005.

Use of illegal drugs by depressed teens increased:

In all cases but binge drinking, substance use was twice as common in the depressed adolescents compared with their non-depressed peers....

Among girls, the FDA advisories and decline in the treatment of depression increased the use of illicit drugs by 5.4 percentage points and increased nonmedical prescription drug use by 4.3 percentage points.

Depressed kids also got in more trouble:

Fighting and stealing both rose disproportionately among depressed adolescents in the post period.  Fighting rose by 6.5 percentage points and stealing rose by 4.6 percentage points in the full sample, although the effects on stealing were driven entirely by depressed girls. 

In other words, it looks like the FDA should consider a black box warning for its black box warning.

For more on depression, read this excellent 2007 piece by Will Wilkinson.

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  • Bill||

    "it looks like the FDA should consider a black box warning for their black box warning."

    Very nice, Katherine!

  • ScienceSkeptic||

    Ms. Mangu-Ward is another believer in better living through the chemistry of drug companies. She practices the same religion as Reason's scientism
    http://en.wikipedia.org/wiki/Scientism
    correspondent, Ron Bailey. The liberty to choose to put pharmaceuticals or junk food in your body does not equate to the wisdom of doing it. Not all drugs are bad, but many in Big Pharma and Big Food Processing are. The anti-depressants Ms. Mangu-Ward touts are nothing but placebos. They don't cause suicide, they don't stop suicide.

  • Sparky||

    Where are you going with this? Are you saying people shouldn't be free to put whatever substance they want into their bodies? Even if you don't like it?

  • RandomGermanDude||

    While SSRIs are overused they are viable for the treatment of patients with strong depression and better than placebo in those cases.

  • The Claw||

    Damned if you do, damned if you don't. If you can't count on the doctor to keep up with the literature on the drug, there's not much you can do, huh, except err on one side or the other. You'd think if they were doing their job, a black box would have no effect, because they'd've taken the info into account already in their prescribing -- that is, unless it's proprietary info that only the drug maker and FDA know!

  • Contrarian P||

    Have you ever bothered to check into how much medical literature there is? There are hundreds of articles published a week. Even if you have time to read it all, so much of it is questionable, as most of the medication research is drug company funded. In the case of SSRIs, there is a considerable body of research that shows little to no effect when confounding factors are eliminated. SSRIs are some of the best selling drugs on the planet and many of the patients that take them are convinced of their efficacy. They want to take them regardless of the potential side effects. About all you can do is to warn them that there are side effects (which typically number in the dozens) and highlight the main ones, but many parents want a pill to fix their child (as opposed to doing any actual parenting) and will continue to want it despite any evidence to the contrary. I can't even get parents to accept that antibiotics don't kill influenza and rhinovirus. They insist that they work, because the last time junior had a cold, they gave him some leftover amoxicillin and he got better. Science be damned.

  • The Claw||

    Well you seem to be up on the literature, so why shouldn't doctors be?

    One reason patients are convinced of the efficacy of SSRIs is that they make them feel different. They feel more different than they would with inert placebo, but it's still possible that the SSRI is an active placebo -- that is, a drug that pleases them. That's how it is with a lot of psychoactives that people take: They make them feel different, and for a lot of people, different is better. Since feelings are by definition subjective, what's wrong with that?

  • sarcasmic||

    Botched plastic surgery leaves woman with 'uniboob'.

    http://www.dailymail.co.uk/fem.....geons.html

  • T||

    Not clicking it, but thanks for thinking of us.

  • Amakudari||

    She also had a nip-tuck operation on her eyelids that has meant she is unable to close them.

    Yet, shockingly, she's not that bad. With clothes on. And eyeliner. And a still photo.

  • Sparky||

    That's not a bad idea. Think of how much easier they are to work with when they're already pinned together.

  • Mensan||

    The uniboob is bad enough, but at least she was able to get that corrected. The part that really bothered me was that the surgeon decided on her own to operate on the woman's eyelids without her consent. And now the woman can't close her eyes. Screw malpractice; that's intentional maiming. The surgeon should be in prison.

  • ||

    Even if the eye surgery had gone perfectly, without consent the surgeon committed assault. The kind people go to jail for.

    If he worked in my system, I would be recommending, in writing, that he be terminated immediately. But I'm always looking for a doc to fire, por encourager les autres.

  • Amakudari||

    Drug warriors don't care if teens kill themselves. They just don't want them using drugs, period. Case in point: the War on Drugs.

    At least they die an honorable death or something.

  • Sparky||

    And really, who cares about the emo kids anyway? Amirite?

  • sarcasmic||

    Boys who wear girls' jeans deserve to die.

  • Amakudari||

    Wouldn't know. Most of the emo kids when I was in high school were Mormons, who were always eerily cheery. I figured they were in it because they liked thick-rimmed glasses and clothes from Goodwill.

  • R||

    I think you're confusing emo with hipster.

  • ||

    I MUST SLUMBER, PER SE

  • Amakudari||

    Nah, them's goths.

    They're reputed to be fictitious, or number so few that their entire population can be seen in The Cure retrospectives. Commonly mistaken for mallgoths.

  • ||

    Don't get defensive just because you were a goth. Like ProL.

  • Amakudari||

    No way. I tried to go prog metal in high school and grow my hair out. Turns out it wouldn't grow down into golden, flowing locks but rather out into something like this.

    Also I had a goatee. Those were glorious days.

  • sarcasmic||

    "To become a non-conformist all you have to do is dress just like us and listen to the same music as us..."

  • jtuf||

    It's no wonder so many teenagers get depressed. Just look at the government run schools we force them to attend. We should grant teenagers the freedom to pick a better environment. While I support parental and teenage choice on drug use, I think the drugs cause more harm than good.

  • Bob||

    Major reform needs to be done to the FDA. It simply does more harm than good.

  • Jerry||

    Well 2004 was also the year president George W. Bush was going to be reelected. So there's that.

  • Rosiecee||

    Since the Black Box warning for those 24 of age and under, the suicide rate has dropped for those of that age.. The suicide rate in 2004 does not count because the warning did not come out until late Sept. 2004.

    Here is the article on sucide rates going up for everyone but those under the age of 24.


    http://www.ssristories.com/show.php?item=5096

    Paragraphs 6 & 7 read: "According to data from the Centers for Disease Control on the American Foundation for Suicide Prevention website, suicide rates have risen for every age group above the age of 25 over the past several years: "
    In 2007, the latest year for which national data are available, 45- to 54-year-olds had the highest rate of suicide at 17.7 per 100,000 people. It was the highest rate for that age group since 1977.
    Suicides among the age group 55 to 64 increased the most, to 15.5 from 14.5 , the highest rate since 1990.
    Suicide rates for 25- to 34-year-olds also rose, to 13.0 in 2007, from 12.3 in 2006.
    SSRI Stories note: The Black Box Warning for suicidality required for antidepressants by the FDA is working. Those aged 24 and under showed no increase in suicide rates as did the other age groups. The Black Box was placed in Septermber 2004. This data is from 2007.

    13th paragraph from the end reads: "Volek was getting counseling and was on medications. He was taking all the right steps, Wilson said.

    6th paragraph from the end reads: "Around 9 a.m. the next morning, Wilson learned of Volek’s death [suicide]."


    http://www.columbiamissourian......ide-rates/


    Suicide prevention efforts shifting toward at-risk group: middle-aged men
    'Men hide it; women ask for help'
    Sunday, August 21, 2011 | 12:01 a.m. CDT

    BY Laura Heck

  • adam||

    There are costs of any policy. Pointing those out isn't too helpful unless you also point out the benefits. If 20 more teens committed suicide, but 1,000 didn't die of complications, then the policy seems justified. What was the warning for? How serious were those consequences? Did the warning achieve its intended effect?

  • Brandt Hardin||

    Big Pharma is the REAL drug cartel in North America. Their overmedicating of the American public through obscene advertising leads to nearly 100,000 deaths per year! Prescription drugs are more dangerous than any felony drug substance in the world including heroin, cocaine and even alcohol combined. Read about this issue and what’s killing people at http://dregstudiosart.blogspot.....grams.html

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