FDA Warns Docs about Zyprexa

February 1, 2010 at 10:53 pm 5 comments

In news of the not-so-surprising, The LA Times reports that the FDA has issued a warning to doctors concerning increased metabolic risks in adolescents taking the drug olanzapine (Zyprexa). Risks include rapid weight gain and an increased likelihood of weight related physical concerns like diabetes and high cholesterol — serious problems that, you may remember, most doctors can’t be bothered to watch for. While this particular warning is limited to young people, you’ll find that the same risks are present in adults though it appears that adolescents are at a higher comparative risk. Interestingly, the warning applies only to those ages 13-17 being treated for diagnoses of schizophrenia and bipolar disorder, leaving out the growing number of even younger people for whom the drug is not approved but administered off label.

The agency has not approved the marketing of olanzapine — sold under the commercial name Zyprexa by the drug maker Eli Lilly — for use in children under 13 who are diagnosed with schizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the “atypical antipsychotics,” is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.

The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels — all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs — Seroquel and Risperdal — were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.

More than 17 pounds in 12 weeks? Whether a parent or a doctor, you wouldn’t think you’d need clinical trials and an FDA warning to notice such rapid weight gain in a kid. A pair of eyes and even vague concern should do the trick and while the primary problem is not cosmetic, rest assured — if you don’t notice the weight gain, the other kids will. So in addition to battling the middle school years with a psychiatric label, they can now do it overweight and worrying about their heart health and diabetes. That should do wonders for their emotional well being in the formative years. Actually, the LA Times erred on the conservative side in reporting those numbers. From the JAMA study that prompted the warning:

Patients taking their first-ever course of drugs marketed as Abilify, Risperdal, Seroquel and Zyprexa experienced weight gains ranging from about 9.7 pounds for Abilify to 18.7 pounds for Zyprexa. (Seroquel users gained about 13.2 pounds and Risperdal users gained about 11.7 pounds over 12 weeks. A comparison group of children with a diagnosis of severe mental illness but who were not on the medications gained less than a half-pound in the course of the study.)

With the youth market for antipsychotics constantly expanding and these drugs being approved or used off label for a range of behaviors broadening well into the mildest end of the spectrum (attention deficit, irritability), we need to be taking these risks seriously. The shift from using drugs as a last resort to using drugs as a means of grooming children for desirable behavior can’t be ignored in a discussion about antipsychotics in children and little good can come from making a child’s physical health take a back seat to a theory on mental illness. Do we really want to expose young people to greater risks of cardiovascular disease, diabetes and high cholesterol to “correct” moods and behaviors?

With the influx in young people on antipsychotics you might think this is the time to be looking into these problems but I think the time was fifteen years ago when Zyprexa was poised to enter the market. Now here we are repeating an often seen pattern — downplay risks for the duration of a drug’s patented life and spill it all at the end when its exclusivity is about to sunset — making the older, cheaper drug poor competition for its maker’s new and exclusive replacement. I wonder what the kids think about all of this. Something tells me no one’s really asking.

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Are You S.I.C.K.? Man vs Machine

5 Comments

  • 1. susan  |  February 2, 2010 at 8:43 am

    kudos

  • 2. dogkisses  |  February 3, 2010 at 11:46 am

    Hi, I wanted to add here that I watched my son gain 50 pounds on Abilify. 50! The doctors said, “Abilify is not known to cause weight gain.” My son said it was awful b/c he could never get full. He has still not lost all that weight and it’s been several years. He was never over weight until then. It also caused his cheeks to swell and his liver panel to be abnormal.
    In my experience, psychiatrists are generally not going to admit to any negative effects of anti-psychotics and if they do then what follows is always the same: “You gotta weigh the risks against the benefits.”
    I tell ya, I’ve lost trust in psychiatry.

  • 3. abellve  |  February 4, 2010 at 9:20 pm

    Yet somehow, they do it all in the name of health. It’s not a matter of risks and benefits but compliance and repercussions. Unfortunately, in the eye of many among their ranks, the benefits always outweigh the risks.

  • 4. Randi Salinas  |  May 14, 2012 at 3:16 am

    Making the decision to medicate your child with an antipsychotic is the hardest decision you will ever make. Unless you have a child that is severely impaired you have no idea. My husband and I have been in denial up until our daughters first year of school and she was a danger to little children as well as adults. She saw things, heard things, cut herself, said she wanted to die…all this at 4. Can you imagine? There is something going on with todays youngsters. No one knows the real answer on why mental illness is showing up in the very young, but it is. Yes I agree that maybe some psychiatrists or developmental specialists may prescribe it like it’s no big deal but we have the best of the best. We tried so many different things before Risperdal and when we saw results right away we wished we would have started sooner. You want to talk about weight gain and the mental affects of being teased in school and how negative they will feel from the weight gain but it is so much better than when they feel they want to kill someone, or attack a person for no reason, or go into a raging tantrum for an hour in front of thier friends…if they even have any because quite honestly noone wants to be friends with a child who cannot control their anger and hostility. Trust me…antipsychotics can be a godsend for the overall well being of your child.

    • 5. abellve  |  May 14, 2012 at 10:25 am

      I hope you know I am not passing judgment on parents doing their honest best and I genuinely hope for the best for your child — whatever path you choose or are left with. There are other ways but they are often kept well out of reach for the acerage person and still are very limited. Sadly there are minds that operate well outside the “normal” range and as a society, were incredibly ill prepared and poorly structured to deal with that fact.
      Unfortunately dealing with pharmaceuticals has people dealing with a corrupt industry and Zyprexa in particular has known since before its release that it caused the kind of health risks that never should have allowed it to be approved by our very lax FDA. I’m not faulting you for the choice you have made or been forced to make. I’m faulting the industries involved for limiting your choices in the interest of profit, for covering up and allowing seriously dangerous problems and an overly prescription-minded public. Some parents would like to know these things and they are not getting it from drug companies or doctors acting like a sales force.


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