FDA warnings - opinions anybody? | ADHD Information
Hi there, everybody!It's been awhile since I've posted here.....my 14 y/o son is doing SO well taking 54mg Concerta w/10 mg Ritalin in the AM and 5 mg Ritalin in the PM....and then I read the latest-greatest FDA warnings about all the ADHD meds.
Yeah, the dr. checks his blood pressure during each visit (every 3 months now)...I wonder about the heart stuff mentioned in the FDA warnings.
Any comments about all of this stuff that anyone would like to share?
Thanks to all who post!
I am not trying to open a can of worms but this is why we don't medicate -- there is a history of heart trouble in our family and the risks outweigh (at this point) the benefits for us. We may get to a point where we have to medicate, but we are trying to avoid it. So far, so good!
I think that this is the same stuff we already knew about....that people with underlying heart problems may have serious consequences to taking stims. As long as you know your son has no such underlying conditions....no problem.
When I read it (the 'new' warnings), I saw nothing new...
Yeah, I thought the same thing.....but, for some reason, the "new" warnings gave me pause.How does one determine any underlying heart problems? My son was 11 wks premature and his heart was OK back then.
Guess I should ask the doc - huh?
Thanks so much for your replies!
Testing should reveal any tendencies toward any heart problems. EKG, etc..Most Psych's will do a premed EKG to rule out underlying problems. If one was not done request one, simple as that!We're on the second psych treating our son...the first one never ordered an EKG....and neither did the second one. I wasn't sure if an EKG would be the only test necessary to rule out underlying problems....needless to say, peeps like you folks who deal with this kind of stuff everyday often have the best answers!
Believe me, when we see the psych today, I'm going to be asking for an EKG.
Thanks!
I have definitely learned most of what I know about this disorder, and meds to treat it from message boards. I have learned EVERYTHING about how to deal with the med side effects from the message boards. If not for them, my son would be medicated for ADHD, but not sleeping, eating, and would have anger issues all related to the stimulant he takes to control the ADHD.
Welcome to the board! Ask away...someone will have advice for you.
Message boards seem to be the best sources of information, for sure!!! My fiance has a seizure disorder and the EFA boards were a lifesaver for me during his meds change and everything related to his seizures .I must admit, we've been very fortunate in the fact that, once my son was accurately diagnosed and got up to the right meds level, he's been doing very well.
I've read many posts on here and can tell that everyone on here is awesome and truly cares....heck, we're all in this together - why not support each other - right?
In fact, it was the people on here who guided me when the first psych Rx'd Risperdal for my son and I was uncomfortable with it. My son was experiencing a bug phobia and the psych's first inclination was to Rx Risperdal rather than consider lowering his ADHD meds dose which could have been the cause of the heightened anxiety.
The second psych eliminated the Risperdal and then lowered the ADHD meds doses slightly....all is fine now.
So, yes...thank God for message boards!
Thanks again....I truly appreciate your comments!
Well, folks....just got back from the psych's office. Yep, an EKG and blood work is standard practice BEFORE Rx'ing ADHD meds. The doc told me that, since we came to him for a second opinion, he erroneously assumed the previous doc ordered an EKG and blood work for my son.
Thankfully, at least my son's PCP ordered the appropriate bloodwork and everything came back normal.
And, the psych comforted me somewhat in reminding me that the ADHD meds have been around for over 65 years and have an impeccable safety record.
The current "alarm" is once again due to those poor souls who have undetected structural heart defects....and he reminded me that even peeps who don't take ADHD meds can have undetected structural heart defects (probably that 16 yr old who dropped dead on the ice).
The doc told me that he ordered an echocardiogram for his daughter when she wanted to play basketball....he feels every child should have an echo but it's not recommended by the pediatric association nor the psychiatric association (can't remember the correct "terms").
Anyhow, he agreed with my idea about my son getting an echo...more so than an EKG....especially since my son was born 11 wks prematurely - definitely at higher risk for heart defects even though none were detected early on.
I can't thank you all enough for the valuable information you provided to me today....the doc was quite impressed to hear about the various things you folks had to say.
Confirmation, once again, to listen to your gut!
deeac5439135.6469444444I haven't talked to the doctor so much about the board here, but I did mention it to the nurse at the doctor's office and she said that some people 'pooh pooh' message boards, but she really thinks message boards are a great thing for people to learn things they wouldn't otherwise. She said that the support is also very important.Well I agree with that nurse, the support is what is keeping me sane!Thanks to you all! I am definitely going to ask for further testing. WOW... I really need to talk to my daughter's ped... my daughter has a heart murmer and had a hole in her heart for the first 4 years of life... I really need to look into a cardiologist to check her heart... the sad thing is .. it never even crossed my mind. Thank-you everyone for your post and information.I am new here and I was just looking at this topic and wondered what anyone thought about the fact that my 6 year old son DID have an EKG and he does have "sinus arrythmia" which is when your heart skips a beat. This runs in my family. The pediatric cardiologist and the neurologist who sees my son both said that the meds were ok but now that I've seen this topic..... I am wondering... Anyone have any input for me...
All of these warnings definitely beg the question as to what kinds of upfront testing docs are doing. I know when our doc offered us Ritalin it was w/o any sort of testing upfront (for any other unknown condition). Something about that just didn't sit right w/ me.
This heart stuff is scary, for sure!!!The boy dying on the ice rink after being cleared by his doctor to play hockey is so very sad!!! My youngest son has a heart murmur and our PCP ordered an echocardiogram...no structural problems, just a "noisy" heart. I wonder if that boy's doctor followed up to this extent since my son's former pediatrician dismissed the heart murmur with no further testing. Obviously, if that poor boy's murmur was due to a heart defect, etc. things might have turned out differently if the defect/whatever was diagnosed....again...so very, very sad.
And, after reading what you folks have said about "pre-med" heart testing, I'm angry at both psych's for not suggesting this....even our PCP....yeah, he tested my son's liver and kidney function to make sure the ADHD meds weren't having an adverse effect but why no heart function tests??
My ex's side of the family has hypertension....I would think the psych's continued monitoring of my son's BP would take care of that concern. But, truly, how would someone know about underlying heart conditions without testing?? Sorry to say, but it seems as if some members of the medical field are dropping the ball.
Thanks to everyone for their valuable posts - the psych will be hearing today that I want my son's heart function checked.
A side note to Jenny.....I would think, after reading this thread and sharing the info with your dd's doctor that he/she would order whatever tests are necessary to check for underlying heart conditions. I'm sure your insurance company has procedures that must be followed to ensure coverage for the expense of the testing. Best of luck to you!
deeac5439135.4805092593The ekg (to check the electrical activity) and blood work (including cardiac enzymes) are both used to look for heart problems. The baseline blood work is used for other things as well. This is not going to cover every rare posibility, but other methods are invasive and have greater risk. Bloods and ekg are repeated from time to time (all docs have thier preferred schedule) for continued monitoring. This is normal for most meds that are used over a long period. I get routine tests for thyroid function (I'm on thyroid meds) and liver enzymes (for lipitor). If the doc is not monitoring your child, this shows that the doc is behind the times and is playing the odds with your child. More and more docs are erring in the direction of caution and closely monitoring the kids.
Everyone in my family (me, mom and dad, all 4 grandparents) have hypertension. Mom's had 2 heart attacks, goth grandpas died of heart attacks. Is this underlying heart condition? I'm scared now. I mean, my dd has SEVERE ADHD. Seriously, it's bad. She needs meds, but now I'm scared.
A pp said does an EKG even determine all possible underlying heart conditions? Do you have to have an order for one? Do you just go to a pediatric cardiologist and ask for one? Help?
[QUOTE=chasesmom79]I think that this is the same stuff we already knew about....that people with underlying heart problems may have serious consequences to taking stims. As long as you know your son has no such underlying conditions....no problem.
When I read it (the 'new' warnings), I saw nothing new...
[/QUOTE]
Actually, I am pretty sure Strattera did not carry a black box warning (and perhaps a few of the others). This would be the "new" information.
I have never dealt with strattera, but I am almost sure that the insert that comes with Chases meds has much if not all of this info in it. It is 2-3 pages long.
That and with the Canada black box scare a year or so ago...I was already aware of this information.
The FDA is looking at the patient education materials on all meds and even alternatives at this time. They naturally start with the ones that are potentiallly more risky, are politically sensitive or where the industry has been lax. Some of this stems from the TV and magazine ads that you see these days. Those who sell alternatives to standard medicine are also being scrutenized for misleading claims in advertising and on web sites. They are no longer allowed to use testamonials and are supposed to only make claims that have data to substantiate them. It is hard to enforce the regulations in this area because of the large number of people selling these items (especially over the internet) who don't even realize they are making unsubstantiated claims.
More accurate patient information is always a good thing.
vickie39135.4303356481I also believe that educating ourselves to the best of our abilities is a good thing. And it's great that this board is here so we can chat with people who have experience with these medications. At least we can feel that we are making fairly informed decisions. That being said, underlying heart conditions is a very serious matter. If there is any suspicion of a heart issue, it should be addressed. Just last week (and this is still unbelievable to me), at the ice rink where my girls take lessons, a 16 yo kid DIED on the ice with no warning. He was perfectly healthy, but with an underlying heart issue (a slight murmur) and he was cleared to play hockey by his doctor. Now this has nothing to do with ADHD meds, but the point is that underlying heart issues need to be addressed.You are right about educating ourselves on these issues so we can take an active role in our own heath care and the care of our kids. Unfortunately it is hard for many people to sort through all the unreliable information to find reliable information. Reading the full prescribing information (available for all meds) can be daunting for people without at least a basic understaning of medical terminology. We are not taught to interpret this kind of information unless we head in a medical or science direction somewhere in our education. Groups like this forum help alot at getting people information in many areas, so that they make thier decisions based on information and what fits into thier belief system.
Warning- random heart comments
: My old boss has a heart murmer and cannot drink caffeinated drinks. My sister-in-law found out she has a slight valve problem when she was hospitalized after taking a diet suplement containing ephedra (while drinking her normal caffinated drinks and smoking). There is speculation that the incidence of heart problems should acutally decrease in the population of people taking adhd meds compared to the rest of the population (the numbers are the same right now). This is because people consisering ADHD meds are more likely to be screened for underlying heart problems and not be placed on stimulant meds if such a condition exists.
An echo is the best test to detect structural defects of the heart....there is also bloodwork that can verify heart function as well.
I was shocked to hear from my son's psych that the pediatric cardiologist he works with begged him to NOT send kids for echos....the cardiologist's reasoning was that they would be inundated.
The cardiologist also said that the risk is so minimal - that there is a fraction of a percentage of people who have structural heart defects. (this is why the Pediatric Association and Pediatric Cardiology Association advise against echos pre-ADHD meds and only recommend EKG's)
The psych and I both feel if an echo saves one life, it's worth it. The psych feels every child should have an echo....in fact, he ordered one for his daughter before she started basketball.
I was happy to hear my son's psych positive response to my involvement on here...that, to me, is a sign of a confident doctor.
Thanks again to everyone - this place is awesome!
deeac5439136.2642361111
[QUOTE=bahamamama]I am new here and I was just looking at this topic and wondered what anyone thought about the fact that my 6 year old son DID have an EKG and he does have "sinus arrythmia" which is when your heart skips a beat. This runs in my family. The pediatric cardiologist and the neurologist who sees my son both said that the meds were ok but now that I've seen this topic..... I am wondering... Anyone have any input for me...[/QUOTE]
If you are still nervous, request an echo for your son...better safe than sorry!
last night i was at a talk that was on adhd and the speaker was my boys doctor. he was talking about this scare with the heart conditions. he said that in the articles and news they dont tell you that the people that died were people who were not prescribed the med and got the med from someone else. and also that they were taking the whole bottle or they were mixing it with alcohol.
my sons dr is very well educated on adhd and med studies. if you have a good dr most of the time they will listen to your concerns. and they will take action.
i agree, that message boards are a good thing because we get to talk with other parents that have kids with adhd. it is hard to talk with someone that has no idea what you are going thru. this board has helped me alot and it helps to know that you are not the only person in the world going thru what you are going thru.
thanks to all of the support.
Actually, I am pretty sure Strattera did not carry a black box warning (and perhaps a few of the others). This would be the "new" information.
[/QUOTE]I don't know when the black box warning started... but my daughter's Psych did advise me of the Black Box warning and all the results from the FDA about possible suicidal thoughts etc.. She also asked about her heart, kidneys, and liver and overall general health. I advised that she's been healthy but she has had 2 seizures (she's 5 1/2) one of those seizures was on Feb 3rd. So her Dr said NO to Stimulant meds and started her on Strattera and that's when she notified me of the risks/possible side effects. It's also on her Prescription information sheet we got.
I was also given a Kit from my Dr for Strattera when I started on it this past Wednesday. He also asked me about my heart, kidneys, liver etc..
jmdalton -- you might want to question your doctor a bit more:
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"The FDA conducted an analysis of adverse event rates for the following ADHD drugs: amphetamine/dextroamphetamine (Adderall, Adderall XR, Dextrostat, Dexedrine, and Dexedrine Spansules), methylphenidate (Concerta, Ritalin, Ritalin SR, Ritalin LA, Methylin, Methylin ER, Metadate ER, and Metadate CD), methamphetamine (Desoxyn), and dexmethylphenidate (Focalin). Results of the study found higher rates of serious cardiovascular events and sudden death for amphetamine than in methylphenidate in both children and adults, with more events observed in adults than for children.
I doubt an FDA analysis would be based on people injesting an entire bottle, drinking alcohol at the same time, and hijacking other's meds. Those dangers were already covered under the existing label.
bahamama-- my son's cardiologist said that the danger with stimulants is developing arrythmia.
Actually, the FDA analyses all adverse events reported to it related to the meds. So if you show up in the ER with an overdose of an ADHD med that was not yours, it gets reported as an adverse event and would be included in the analysis. They then further break down the groups where posible to determine information that might be useful in reduceing these incidences.
The criticism here would be that adverse events may be under reported (and most likely are) so how do you extrapolate the numbers to the real number of occurances?