Saturday, October 23, 2010

Musings on a Package Insert

How many of you, other than health care professionals, have actually read all the way through a package insert for a medication? If you are taking or administering any meds that come in their original packaging (as opposed to pills that the pharmacy counts into their own bottle), you've probably at least seen them -- a large thin sheet of paper, covered with miniscule type, folded into a small square. I have to confess, I usually don't go into such depth, preferring to seek summary information online if I need more than what the doctor tells me verbally.

But package inserts are available online too, and I've been poring over a particular one: Abilify (aripiprazole), one of two FDA-approved meds for "treatment of irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods)" in children ages 6 to 17 years. The Abilify insert prints out to eighteern 8.5x11 pages in two columns of something like 8-point type. It's so long because Abilify is approved for use in 6 other ways other than pediatric autistic irritability, including particular situations around depression, schizophrenia, and bipolar I disorder. For all seven indications, the insert has to recount studies, warnings, side effects, dosing, etc.

Here are some of the things I learned about Abilify from the insert:
  • "The mechanism of action of aripiprazole, as with other drugs having efficacy in schizophrenia, bipolar disorder... (etc.), is unknown." In other words, studies show that it works, but we don't quite know why. Yikes.

  • These were placebo-controlled trials, so some study participants got the drug, while others got a sugar pills, and they didn't know which they were getting. 10% of participants who got Abilify dropped out of the trial due to side-effects. Meanwhile, 8% of participants who got the sugar-pill dropped out due to "side-effects"!! Oh, the things we see when we're expecting to see them...

  • 21% of participants on the drug reported sedation; 17% reported fatigue. But at a lower dose (which can be effective), the reports of fatigue were only 3.8%. The insert didn't note any dose-differential on reporting sedation. One in five is pretty high. Something to think about for sure.

  • There's a seizure-precaution in the "Warnings" section of the insert -- and of course Joy has epilepsy, though it's been well-controlled for over two years now. A small number of participants did have seizures during the trials. For the peds studies, that was 1 in 611, combining the autism studies with the bipolar & schizophrenia studies. This does not scare me so much as one might think; up to 40% of people with autism experience seizures, and one of the times those seizures tend to come on is adolescence -- as in, the age of quite a few of the study participants.

  • One thing I didn't find on the insert was anything about differences between boys and girls. Which isn't surprising, since there are 4 boys with autism to every one girl, so the "not looking at the issue" shortcoming is shot through autism research in general. But still.

Perhaps you can guess why we're investigating this, given my earlier reports on Joy's difficult entry into kindergarten, and the injuries she's been causing to self and others since.

The vast majority (95%-ish?) of the "explosive acts," as we've been calling them, happen in 3 limit-setting situations:
-- Joy wants something she can't have
-- Joy has to do something she doesn't want to do
-- Joy has to stop something she's enjoying

Her response is explosive and swift, with no warning to allow intervention. Her Agency 2 staffers call it "zero-to-sixty." For a while, based on a school tally that started mid-September, up to half the "explosives" were directed outward, mostly at staff since that's who she's mostly with, but at other kids too when they're in range. Which means, of course, that it doesn't feel safe to have her around her classmates much.

I think she's bitten 4 (or 5?) staffers badly enough that they've had to seek medical attention.

Interestingly, things have gotten some better in recent weeks. We haven't really had a day described as bad/challenging by school staff since our trip up north. There are more stretches of contentment at school, leading to notes like "short but calm music class 10 min -- enjoyed keyboard play." It's felt better at home too. JoyDad and I feel less under assault, less on pins & needles. On the other hand, the total "explosive acts" tally at school is still in the range of 20 to 40 per day: biting, hitting, hairpulling, headbanging. It's just shifted to self-inflicted rather than outwardly-directed. There's been enough self-hairpulling that her hair is getting noticeably thinner again, though not (yet?) near the level it was last year when her hair became a stim toy and we had to cut it all off.

The psychiatrist we've consulted with Joy is ready to start her on Abilify right away if we want. We are still mulling. We may start this week, or wait a week ro two and see if things continue to improve such that the tally goes down. Either way, we are thinking not to tell Joy's school staff or Agency 2 therapists what we've decided (nor you, gentle readers, as the staff & therapists do check in with Elvis Sightings). We're hoping that their (blinded) observations might serve as a counterweight to ours, which will obviously be informed by a knowledge of whether we're giving Joy the drug or not.

One final note. Up until now I have not named any medications on this blog, other than one incident with JoyDad. That has always felt like a bridge too far in terms of privacy. However, in our information-search about Abilify (and Risperdal, the other of the two), one thing I did was do a Google Reader search on all the blogs I follow. I came across gems like this:
Overnight, it seemed last December, the amp was turned down on his rage. His ability could shine without the glare of interruption or explosion. Suddenly, there was a filter on his impulses and reactions. (But it only lasted 10 months, as the post went on to elaborate.)

Or this:
Enter Abilify. This tiny little pill instantly and quite dramatically reduced (X)'s aggressive impulses. I'll never forget when, just a few days after starting taking it, (X) gave me a big hug and excitedly reported: "Mom, I don't feel like hitting you anymore!" I still get chills thinking about that day. It was miraculous.

I know, these are anecdotes, not studies. But it sure helps put a face on some of what the studies have to report. And by naming drug-names in this case, I'll be putting Joy's experience into the hopper for future questioners who think to do a search in their blog reader (or just on Google in general).

Think good thoughts for us, whatever we decide to do these next few weeks.


Anonymous said...

Thoughts in the positive direction coming.

"Yikes" is understandable, but usually the medical scientists have to have some reasoned background before suggesting a chemical for testing. I mean, they don't just go to the FDA and say ground mosquito antennae might make good nasal decongestant so let's try it!

Having made a case for a trial, they have limited methods for determining the 'mechanism of action' in the human brain (whereas they might have seen the mechanism in some poor deceased test animal). Thus, behavior being the targeted outcome, it is also the data used to allow the medication to go into general practice.

I am happy to read you are seeing some improvement and you have another option to consider. Barbara

JoyMama said...

Mmmm -- ground mosquito antennae! Good for what ails ya -- plus, anything that reduces the mosquito population would be a plus...

I expect to see mosquito antennae as the next big alternative thing. Any day now. MosqAn practitioners will be hanging up their shingles right and left.

Positive thoughts appreciated!

autismand said...

What a tough decision to have to make. Sending good thoughts, and hoping you find a happy solution for Joy (and you)

Kim Wombles said...

Sending you positive thoughts.

The decision of whether to medicate or not is a biggie. We faced that with our oldest when he was four. By the time he was nine, he was on ritalin, clonidine, and risperdal. He came off all meds after he had a stroke at nine, and our experiences with the side effects from the medications versus benefits has informed all our decisions for all three children.

I wish you well as you make this hard decision; you will do the best you can to make the most well-informed decision you can. That's all you can ask of yourself.

JoyMama said...

bbsmum -- thanks so much for the good thoughts.

KWombles -- I appreciate hearing your story. The meds pile-up issue is part of what we face with Joy, since she's on two pretty strong drugs already for the seizures. One of those drugs is addressed in the Abilify package insert, since it is also used in the other conditions that Abilify is used for; the other, we still need our peds neurologist to sign off on. (So I guess we really can't start *right* away). Thank you for the good wishes!

Floortime Lite Mama said...

Sending you many many positive thoughts on the right decision

I know VERY little about medication

Since I am just back from the Autism - asp conference - one interesting thought I heard was that in auties - what comes across as Rage is actually fear and sadness in disguise
And an SSRI - like Prozac - which has much fewer side effects - has great results

JoyMama said...

K -- it's good to have more than one approach available -- we're not kidding ourselves that Abilify is the be-all and end all of all possibilities for Joy. We experienced plenty of trial and error around various medications and combinations thereof for her epilepsy, before we hit the jackpot.

I surely do wish she could tell us what she's feeling....

Thanks so much for the positive thoughts!

Anonymous said...

Ooh, this is a road I wonder if we'll be walking ourselves one day. You are right to weigh the pros and cons carefully. Sending a prayer for wisdom your way.

telemommie said...

We faced this decision this summer with our almost 6 yr old, non-verbal ASD girl. For me the guilt involved and the weight of the decision has been tough. However, we have been pretty happy with the results. We are trying Methlin for focus and Lexapro to balance out any anxiety that might be caused by the Methlin. We've seen an increase in echoalia, better sleeping (once we get her to sleep), and--most exciting--sometimes she will take herself to toilet. Also she will now let me wash her hair. That's a biggie too. I think what it came down to for us (and my hubby is very anti drug) was that we had nothing to lose and we could stop if we needed to. We don't have the epilepsy issue though. And yes, I did read the insert, more than once.
Best of luck to you whatever you decide.

Professor Mother said...

Those inserts are something to read- lots of legal stuff, some scientific stuff, and lots of "well, we just don't know"s. Good researching, Mama!

I think that it's a good idea to name the drugs we're using in our blogs... Otherwise, the only information out there is a) the drug company's proposganda and b) the extremes of reactions- the people that think it's the best thing EVER and those who hate it. Reasoned, practical voices who made informed decisions about choices for their children and who weigh the mixed benefits and challenges of the responses are sooo needed out there in the eworld. Thank you for adding your reasoned voice to the debate.

Now, if we can only get politics as reasonable...