ADHD Medication: Safety and Warnings
In the past 1 1/2 years, there has been a lot of news about the safety of medications for ADHD/ADD. While this has led to many people being very concerned about using medication for ADHD, I hope that it is also reassuring - i.e. the fact that active ongoing monitoring of medication is going on should reassure people taking the medication.
The FDA, Health Canada, and other monitoring agencies in different countries have kept active watch on medications for ADHD.
Last week, the FDA announced new concerns and warnings for ADHD medications - including Dexedrine and Ritalin. I am preparing a summary of this issue - and it will be posted shortly.
With this post, I wanted to provide some background about the issues, taken from two previous reports I have done:
1) Adderall XR: its removal and reinstatement in Canada
2) The FDA concerns and suggestion of a black box warning in February 2006.
Adderall XR - The Canadian Story:
On February 9, 2005, Health Canada (the Canadian version of the FDA), suspended Adderall XR from the Canadian market due to safety concerns. There were concerns that Adderall may have been associated with an increased risk of sudden/cardiac death, and stroke in children and adults taking the medication. View the original statement by Health Canada here.
The FDA in the United States reviewed the Health Canada concerns about Adderall, and decided that there was not a need to change the labeling or availability of Adderall XR based on their review of the data. View their original statement here.
Health Canada established a ‘New Drug Committee’ (NDC) to review the data on safety and adverse events on Adderall XR. The committee included three members - a specialist in childhood behavioral disorders (doctor who is an expert in ADHD), a pediatric cardiologist (heart specialist for kids), and a pharmaco-epidemiologist (expert in research on medicines).
The New Drug Committee reviewed Adderall XR, the safety concerns, and found that there was no increased risk for Adderall compared to other ADHD Medications. So, Adderall was reinstated in Canada on August 26, 2005. The NDC did include the following quote at the end of their report:
That ALL stimulant drugs prescribed in the management of ADHD should be used with caution in patients who:
(a) are involved in strenuous exercise or activities
(b) use other stimulants or,
(c) have a family history of sudden/cardiac death.
You can see the full report of the New Drug Committee here.
Many patients were affected by Adderall XR being taken off the market in Canada. If you or someone you love were affected when Adderall XR was taken off the market, please post a comment and describe the impact on you or your loved one.
2) The FDA concerns about ADHD medications and the suggestion of a ‘Black Box’ Warning in February 2006
On February 9th, 2006, an advisory committee of the FDA met to review safety in ADHD medication. This subcommittee shocked the ADHD world by coming out with the recommendation of a Black Box warning for ADHD Medications - which is a the strongest warning possible by the FDA.
On that day, I prepared a detailed, audio ’special report’ to summarize the issues. You can hear or download this report here:
FDA concerns about ADHD Medication
This article is just the start of a series of articles which will help to review the evolving issues about safety of ADHD medications.I want to keep you up to date and informed!
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Written by Dr. Kenny Handelman - The ADHD Doctor
To find get a FREE special report on ADD/ADHD Medication, visit: Medication Mastery
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September 1st, 2006 at 2:06 pm
while I agree that any medication a patient is going to take needs to be assessed seriously and carefully, so does the aspect of non-medication. My 15 year old son was non medicated and so are alot of his adhd friends (they seem to find each other easily within their peer groups - all risk takers, thrill seekers, impulsive and on the go). Believe me, they have all found a way to self medicate. They all smoke a large amount of marijuana. Marijuana is very easy to get and some of them even steal it from their parents private stashes. Although alot of people think marijuana is a recreational drug, we have found that the adhd adolescents love this drug and use it way more frequently then most. This has caused alot of big problems within each family - getting arrested for possession, smoking during school to get through the day- which leads to suspension, coming up with the money to buy it etc. etc.
The question of self-medication, especially among the adolescent adhd population (they all started around grade
needs to be considered greatly when a parent is trying to decide whether to medicate or not. We wish we had started medication earlier so that perhaps our son would have been able to resist the urge!!!
September 2nd, 2006 at 1:28 am
Thank you for your comment - if I understand you correctly, you are underlining the need for parents to consider the risks of not medicating for ADHD.
You see that your son has taken to abusing marijuana to try to control his ADHD (I believe these teens find it helps settle the hyperactivity - it certainly doesn’t help concentration). You wonder if treating the ADHD earlier may have led to a better outcome in this regard.
When I am having a discussion about considering medication for ADHD, I always review the risks of not treating as well, because this is a very important aspect to consider.
Thanks for this comment.
September 2nd, 2006 at 1:51 am
Hi, Dr.Kenny Steven Tullis wants to let you know that Adderall XR is not bad. I am on 30mg, in the morning & 10mg.of Adderall At night .No problems at all. It has helped me to a good point but not all the. But still good drug. I am an adult with only add. Question for you is there another form of hyperactivity besides somebody not being able to set still as talking to much. Could you PLEASE e-mail me back. Could you also talk more about adult add.
September 2nd, 2006 at 11:47 am
Hi Steven,
Thanks for the comment. I agree that Adderall is not bad - in fact it helps many people.
A couple of comments for you:
1) Regarding only having a partial benefit from one ADHD medication, it may be worth trying two medicines. Although there is little research about it, experts in the field are starting to use two medicines - a stimulant and a non-stimulant in combination. This would mean adding Strattera to your Adderall. You can talk to you doctor to discuss if this could be helpful.
2) Of course you can increase your knowledge of strategies to help to manage your ADHD, and that may improve your symptoms either with or without adding a second medicine.
3) Yes, there are other forms of ‘hyperactivity’, particularly in adults. It may include: a low frustration tolerance (i.e. frustrated easily), a lot of impulsivity (i.e. acting before one thinks), inner feelings of restlessness, etc.
Thank you for your suggestion for more posts on adult ADHD. I will do that
January 14th, 2007 at 1:45 am
Hi. I have a 12 yo. daughter who has struggled off an on with staying focused. She is now in 6th grade and is pretty much overwhelmed with it. She is passing but very frustrated. Homework time in the evenings is like pulling hair out for me. I have to constantly stay on her to get it done and sometimes the math takes us hours. Her teachers complain that she turns in incomplete work all the time, she shows some comprehension problems in school and has sequencing problems in math. We have talked with our school counselor who is also a recently retired child psychologist. After much discussion/evaluation with us parents, my child’s teachers as well as my child herself he feels that she has ADD. She is not hyperactive. In fact, she is the perfect student. It is being suggested that we put her on medication such as Adderall XR or a similar drug for a trial period to see if this helps and then have her evaluated for learning disabilites in math. We are in process now of getting an appointment with the necessary doctors and such. I am very scared about the side effects of medication. I am also concerned since my daughter is in the throws of puberty as to whether or not these medications can effect that since I read somewhere they can affect growth. I am desparate to see this child get some help yet afraid of making the wrong decision about medication. Any advice would be appreciated.
January 14th, 2007 at 2:43 am
Hi Angie,
Thank you for sharing your concerns.
There are a few comments I can make.
1) Make sure there is a thorough assessment to ensure there is in fact ADD there.
2) Psychological testing is almost always needed, but particularly in your daughter’s case - so do get that when it is possible.
3) I hear that you are concerned about the risks of medicine. My advice to you is to get clear advice from the doctor involved, and then give the medicine a try. Rather than waiting years out of concern for side effects, try the medicine for 1-3 months to ‘test it out’. If in fact your daughter has ADD, and the medicine works (about a 75% chance it will), then you will know if the side effects are a problem.
The issue of growth slowing is likely only a concern for about 3% of children. The doctor can monitor your daughter’s height and weight over time to ensure that she is not in that 3%. If she is, then the doctor can catch it, and discuss options with you.
I hope these comments help you in your discussions with your doctor about treating your daughter’s (possible) ADD.
January 24th, 2007 at 10:55 am
After all the evaluations with the psychologist and a visit to our family doctor yesterday, my daughter was given a prescription for 20 mg of Adderall XR. She started it this morning. About an hour and 15 mins. after she took it she was complaining of a headache and feeling dizzy so I gave her a Tylenol. I took her to school about 15 mins after that. She was sitting in the car with her head against the seat and her eyes closed saying she was trying to ease her head.
I must admit that I am a nervous wreck about all this. I didn’t sleep much at all last night because I kept wondering if we are doing the right thing. I have read so much information about addiction with the long term use of this drug at higher doses. I don’t know if her dosage is considered high or not but I did see on the pamphlet they gave me that there are lower and higher dosages and hers seems to be about in the middle. How does one know if addiction is becoming a problem in a 12 year old? Also, how long before I will know if this is helping or making things worse?
On the flip side, I don’t know what else we can do but to try this because our daughter is doing so poorly in school. She has always made good grades until last year when things started slipping a bit and now she is barely passing 2 subjects and failing in another. She is still to have testing for learning dsiabilities once her medication is regulated. At least that is the plan assuming the medication helps her to concentrate better.
February 12th, 2007 at 9:50 pm
Just to update, after starting the 20 mg Adderall XR my daughter had severe headaches and nausea the first day and was crying and totally a wreck. I called the doctor and he lowered her dosage to 10 mg. Things were better on this dosage but it still took her a good 2 weeks to start adjusting to the side effects. Don’t let anyone fool you. It can be a rough start for the kids going on this stuff. However, 3 days into the medication the teachers at school were reporting that she was like a different child in the classroom and wanted to know what had changed. We had not told them she was starting medication so that the school psychologist could get an unbiased evaluation on her performance. She has since pulled her F in math up to a C and her 2 C’s up to Bs. Most of the side effects of the medication seem to have subsided other than she still has a bit of a hard time getting to sleep at night. She does say that she feels she can concentrate better in school now and is starting to be happy about it all. It has been an emotional struggle for me as a parent but I do see some improvements. She is also able to not take the med. on the weekend and that has been good for when she wants to spend the night at a friend’s house. I guess for now this is a working solution.