Posts tagged ‘Off Label’

FDA Warns Docs about Zyprexa

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.


February 1, 2010 at 10:53 pm 5 comments

Doctors, do your homework!

   It’s common practice in prescribing medicine to offer drugs for reasons other than their FDA approved purposes. This off label prescribing of drugs is nothing new and while we’d probably like to think doctors are prescribing drugs off label in a judicious and well thought out manner, that doesn’t seem to be the case. As it turns out, according to a University of Chicago study, more than 40% of prescribing doctors do not even know the approval status of drugs in relation to their indications.

   When the study was limited to drugs they’ve prescribed in the past year, the increase in knowledge was marginal at best. Psychiatrists demonstrated a greater knowledge of approval status than primary care physicians. This doesn’t mean they are more reserved in off label prescribing, just that they know better.

    You’d think that for a doctor’s salary you could expect them to do their homework, really know about the drugs they are so quick to dispense, and while it’s not limited to psych drugs its impact is substantial in that market. Drugs are approved based on efficacy and safety, basically a risk vs benefits scale. With such lax FDA standards, if a drug doesn’t gain approval, it is either highly ineffective, alarmingly dangerous or both. Most antipsychotics just squeak by but despite this the numbers for antipsychotics being prescribed in recent history have skyrocketed  — and it’s not because more and more people are becoming psychotic. Antipsychotics have seen such an increase in numbers that they’ve beaten out the old champion, lipid regulators, as of last year thanks to a more than 50% growth in sales over the course of four years. It just might have something to do with companies like Eli Lilly, who illegally marketed their antipsychotic Zyprexa off label for bipolar and dementia, for which it is not only not approved but proven ineffective. For a drug approved only for “diseases” that a relatively small part of the population are diagnosed with to beat cholesterol drugs in our Big Mac nation says more about marketing than it does about mental health.

   The level of disregard that such dangerous marketing implies is deplorable and the fact that doctors aren’t even putting the work in to know which drugs have which approvals is astounding. Even a small number of doctors not demonstrating a working knowledge of the drugs they dispense is shameful but to know that the numbers are nearing and in some accounts exceeding half — that’s frightening. We’re not talking about cold medicines here with side effects like drowsiness and upset stomach but drugs that often shorten lives by way of metabolic syndrome, stroke, heart failure and decrease quality of life in any number of ways for a lot of people. If you are a potential patient/consumer, do your homework. It’s entirely possible your doctor hasn’t done his.

August 21, 2009 at 9:41 pm


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