More black box warnings on the way

More black box warnings on the way

Black box warnings are the FDA’s strongest measure to inform physicians and consumers of a drug’s potential dangers. They seem to be getting more popular. Yesterday, an FDA advisory committee recommended adding black box warnings to ADHD drugs. They would warn of risks for heart attacks, stroke, and sudden death –a pretty high price to pay to get Johnny to conform to school norms. I’ve discussed this topic in the past and have noted the potential side effects, but frankly I’m surprised to see things move so quickly.

The vote was close, reflecting the split among clinicians and researchers in the field. If the FDA does follow through with the warning labels it will provide parents who don’t want to medicate their kids but who are pressured into it (often by their schools) with some powerful ammunition. But I wonder if this is really the best way to address the issue.

The panel was unanimous in recommending that the drug makers include a medication guide with their products that parents and patients could use.

See MedPage Today for more.

February 10, 2006

6 thoughts on “More black box warnings on the way”

  1. Hey, it’s time for you to come clean on this issue, David. I’ve read your various screeds against medications for ADHD. What’s your real beef? Sure, you’ve said they’re overprescribed; you’ve said they’re dangerous. But why do you care so much that you post on the issue so much? What’s your bias?

  2. Don,

    I must say, that is a very odd remark. Bias? What are you talking about? Why does David keep going on about it….well, because they are dangerous and overprived and they are being given to our children. How is that for starters?

    These poisonous drugs are being inserted into as many as 10% of American children. It is VERY big business.

    “Spending on ADHD medications increased from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a market research company that specializes on the pharmaceutical industry (AP/Rochester Democrat and Chronicle, 1/4).”

    That is a lot of money.

    Have a look at the front page of Medscape.

    It carries this advert:

    Industry Spotlight
    Information from Industry
    CONCERTA® (Methylphenidate HCI) Extended release tablets

    This is a big, big worry in the UK too.

    Keep going, David.


  3. Don,

    I’m not sure I have any particular bias. My opinion is that ADHD drugs should be used as a last rather than a first resort. The drugs are often suggested by teachers, principals,and guidance counselors to make the school easier to run; that’s not necessarily in the best interest of the child.

    I’m worried about the risk of side effects inherent in taking almost any drug over a long period of time. I’m also concerned that once Johnny starts taking ADHD drugs he will feel he always needs a drug to be able to think. In high school, college and beyond this can lead to serious abuse.

    Plenty of drugs for adults are overprescribed and dangerous, too. But I feel the need to speak up more loudly on behalf of the kids –who don’t have much say in the matter.

    Finally, I think my typical three or four paragraph posts are a little too short to be considered screeds. Harangues, maybe.


  4. David, I agree.

    As a doctor, I know that however big a decision it is to start a drug, it is a much bigger one to STOP it. If a new patient joins my practice and is on Ritalin and mum says he has been on it for 4 years I am in no position to make a judgement about how he would be not on it.

    In the UK the world and his wife are daignosing ADHD – the teacher, the sports coach, the clarinet teacher, the school caretaker etc. It is “trendy”.

    And, a disturbing phenomenon – children with behaviour problems from poor back grounds tend to get Ritalin etc, where as middle class children are more like to get psychologists and non-drug treatable trendy diagnoses like dyslexia and “tracking disorders”


  5. Fair enough, David. Here’s my bias: many members of my family, close and extended, have ADHD–some have been diagnosed by physicians, others just think they have it. Of those who have been medically diagnosed, most are on medication. Those who aren’t, in my opinion, probably should be, since their symptoms are impairing their function in society.

    As I read your blog (I’m in healthcare marketing and I like to see what’s going on in the healthcare blogosphere), I’m concerned when I see a bias against stimulant medication. From what I read here, I get the impression that stimulant meds haven’t been studied much. There’s lots of misinformation about ADHD on the Web, and I’d hate to see you contribute to that.

    One large NIH study (I forget its name) looked at whether behavior therapy is more effective than stimulants in controlling ADHD symptoms. While behavior therapy helped, medication without behavior therapy showed a better improvement in symptoms. And when medication and behavior therapy are combined, the benefits are dramatic.

    In addition, I’ve read about research that shows people who have ADHD and AREN’T on stimulants are more likely to abuse drugs and alcohol than those who are.

    I’m very concerned about the potential for heart problems in people who take stimulants long-term. But didn’t the research you referenced in your post show about a one-in-a-million death rate? Even though I’m not a statistician, such a low percentage doesn’t seem significant.

    I agree that much more research needs to be conducted, especially on the long-term health risks of stimulants. I also believe that our public school system and our society sets up kids with ADHD for failure. In a different era, people with ADHD wouldn’t need medication. But to function (notice I didn’t say thrive) in the world we live in, medication is oftentimes necessary.

    Thanks for letting me try to balance the debate a bit.

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