If taken by a pediatric at initial doses (i.e., low for both, without physician’s escalation) at a crucial stage of development (pubertal onset)? Taken for 4 months and 1 month, respectively. Discontinued without consulting doctor.
For example, could it stunt the growth of his prefrontal cortex (it stays permanently at the size at first intake of either pill), or delay or lead onto a wrong path of development of secondary sex characteristics?
What type of test will reveal normal functioning in all cognitive and social areas and size of brain’s components or anomaly in any of those?
Please give, in addition to the test, how to obtain one and how expensive it typically costs.
No. Of course, you’re better off getting the info from a doctor or the FDA website than a message board.
Also important to note that one of the first thing the FDA guides say about each of those drugs is that you should consult a doctor before discontinuing anti-psychotics or anti-depressants, especially in adolescents.
Abilify is approved for children with some forms of bipolar disorder and adolescents with schizophrenia.
If memory serves, wellbutrin has not been approved for use in minors but is prescribed off-label with some frequency.
Anyone?
Because it’s FDA approved for children, does that mean it can’t cause the two developmental problems in my OP? Maybe the FDA approved it because it thought a cognitively underdeveloped person is more manageable than a schizophrenic or someone with bipolar?
What? No way. Any known side effects reported to the FDA would be listed under side effects, contraindications, or a black box warning. The FDA is not going to shrug over something like that just to keep doctors happy.
If you want to know about cases where something similar did happen and was not FDA-approved, search for articles about Mark Geier’s quack “cure” for autism using Lupron injections. Done during childhood, this can damage or destroy normal sexual functioning if done often enough. His medical license was suspended due to his endangerment of children by these “treatments.”
The best course of action is to go to your family physician and take this up with him/her. They can then refer you to a specialist who can administer the test and properly interpret the results.
This is a crazy tough question. In order to properly answer it a study would have to be performed canvassing all children who had taken these drugs. Then, compiling the data, then interpreting the results.
However, going about what I know about these drugs, I would say no. As there is no real indication that either affects actual physical development of the brain.
Since I assume that this question is related to your other question, you really need to talk to a specialist. Everyone here is going to be providing nothing more than an educated guess. And, for something like this I would want a lot more.
what if the FDA only reports side effects that occur greater than a certain percentage of the time?
Also, how would the FDA test for whether abilify or any other medicine stunts cognitive or sexual growth–they’d have to monitor a patient for a few years, so they won’t really know until a few years later.
I doubt FDA studies are longitudinal and last several years (like 4 or 5), from pubertal onset ~12 to 17 or so.
The FDA doesn’t do studies (last I knew); it compiles data from studies from a variety of sources.
I would be highly, highly surprised if drugs that affect reuptake, etc., by serotonin and dopamine receptors in the brain would do a thing to actual brain development or sex characteristic development. It’s been a while for me since I’ve studied this but I just don’t see how it would happen.
As for reporting adverse events - I just pulled out an “investigator’s brochure” for an experimental drug, and problems that happened to as few as one study subject are listed. Those all get reported to the FDA. I’ve reported things like the common cold, headaches, dizziness to drug companies, because they ask about what’s happening to study subjects, and compare frequency to people on placebo. Things that happen statistically significantly more often than placebo are listed.
On the reporting of side effects of a drug - when I was a subject in a drug study for Mirapex (for approval of re-labeling for treatment of Restless Leg Syndrome in addition to the already approved use as a Parkinson’s Disease drug) I had to read a 8-inch thick binder on the possible side effects of the drug. Every side effect reported - even if only by one patient - was in that binder.
While this doesn’t address long term effects, I find it difficult to believe such effects wouldn’t have been noticed and reported by parents.
What it looks like you are asking is for a formal neurological and psychiatric evaluation. My guess is that you really need to go to a physician, licensed clinical psychologist, or other qualified person to get tested and get a valid interpretation of the results (“I got a ‘3’ on ‘gets along well with others’? What does that mean?”) and an understanding of what deficiencies, if any are found, can reasonably be treated and what kind of treatment might be involved. It’s also the case that not all cognitive or social problems necessarily need to be ‘treated’ - that’s something that you, or the person you are concerned about, need to make in concert with their doctor or other qualified professional.
I doubt you can just take a copy of a test from the local university library and administer it to yourself or a friend or family member and hope to get reliable results.
As electronbee said above, the answer is probably “talk to your doctor”. He should be able to help you figure out what you are looking for, whether you are likely to actually need it, and refer you to the right specialists.
Also, why are you interested? Is this for a class project or something where you just need to write up a “typical scenario” and explain the mechanics and economics of neurological and psychiatric exams, or are you concerned that yourself or someone you know might have cognitive, social, or brain component size deficiencies and you want to do something about it?
You seem coherent to me. PASS.
First one’s on the house.
Google FDA and abilfy and read the report for yourself. It’s a 72 page PDF, with links to dozens of other reports with more details on each study. Here’s an HTML version reprinted at another site. Here’s the same FDA report for Wellbutrin.
Interested because I’m worried two medications I took unnecessarily (prescribed, but for something I don’t believe I had) a long time ago might have damaged my brain.
Does Neuropsychological Testing at Columbia University Medical Center (although it seems to be located in an offshoot center) sound like what I’m seeking? Aging & Dementia Treatment in NYC | Columbia Neurology
It seems to allow interested people to call and schedule an appointment without formally needing a doctor’s referral. It can’t be a scam if it’s supported by or affiliated with Columbia Medical Center, but is a “call and set up a visit” normal for this type of testing?
Also, I don’t know whether my general physician would just give me a referral to a neuropsychological testing center without noticing any symptoms–I also can’t articulate the symptoms because I don’t have a metric to compare my neuropsychological functioning against what is normal. I just worry that my potential might not be fully realized because cognitive development was stunted.
OK I will begin to read those two reports, but if I don’t find any reports of stunted cognitive or pubertal growth, can I safely conclude that the two medicines’ mechanisms do not affect cognitive or sexual development as Ferret Herder suggested?
Or maybe there’s a 1 in a million chance among children, and the one other one-in-a-million user simply did not report it to the FDA, so that there’s always the chance that I may have been affected adversely?
How could you tell that it might be a one-in-a-million never reported “side effect” of some random drug you took as a kid, versus an unknown birth defect or mutation or combination of your parents’ genetics or simple oddity of the vast variety of humanity? For instance, one study says that up to 1% of the population is asexual, and there’s really no known cause.
The problem with neuropsych testing is that it is strictly “current state”. If a brain injury or some type caused an issue, neuropsych testing can’t tell you when or to what degree it changed. You need some kind of baseline.
I suffered an acquired brain injury about 11 years ago and as part of rehab went through the whole battery of tests. The psychologist discussed the results with me and it was only by reviewing my history (school, etc) could she make a determination that there were no significant changes. If I had indicated that I was, for example, a patient person that was good at spatial perception while the test results were at odds with that, she could then diagnose that I was affected.