FDA Orders ADHD Drug Advisories for Patients

[Cerridwen]

ROCKVILLE, Md., Feb. 22 -- The FDA has ordered all drugs approved for attention deficit hyperactivity disorder to carry guides to inform patients about the potential for cardiovascular risks and adverse psychiatric symptoms.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research.

<snip>

Fifteen products carry the revised labeling and will be accompanied in future by patient handouts. The products are:

* Adderall (mixed salts of a single entity amphetamine product) Tablets
* Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
* Concerta (methylphenidate hydrochloride) Extended-Release Tablets
* Daytrana (methylphenidate) Transdermal System
* Desoxyn (methamphetamine HCl) Tablets
* Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
* Focalin (dexmethylphenidate hydrochloride) Tablets
* Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
* Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
* Methylin (methylphenidate hydrochloride) Oral Solution
* Methylin (methylphenidate hydrochloride) Chewable Tablets
* Ritalin (methylphenidate hydrochloride) Tablets
* Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
* Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
* Strattera (atomoxetine HCl) Capsules

link for full story

this article includes links to draft Patient Medication Guides.

[derby378]

1. So how big a role did Scientology play in all this?

I take Ritalin, and I was briefed on possible side effects a long, long time ago.

[proud2BlibKansan]

2. Yes, I was going to say they have been telling of these

side effects for many years now.

My whole family is ADD Derby. I took the meds for years and quit only a few years ago. Hubby is still on them.

And my involvement with this disability and its treatment is the main reason I DETEST Scientologists. I used to offer to send them my kids for a weekend - with no meds. Then they would have started believing in ADD and the reason for the meds!! LOL

[Cerridwen]

4. Here's another article in which they discuss what prompted

this action

<snip>

Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.

From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.

In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.

<snip>

link

edit: oops, forgot a paragraph I meant to include.

[DumpDavisHogg]

6. Probably none

I was misprescribed Ritalin, Cylert, and Trilafon as a youth. My parents and I were never told of the side effects.

It turns out I was misdiagnosed with ADHD and actually had dyslexia instead.

Since when is it a "Scientologist plot" to inform people of possible dangers of prescription drugs they might be taking?

Since that time, Cylert actually was banned because it destroyed users' livers.

[derby378]

8. I remember the Cylert fiasco very well

One way or another, we have got to get a Democrat in the White House so that there will be some basic safeguards protecting the American citizen from bad medicine.

[laylah]

3. I worked for over two

years in a residential program for youth. This sh*t was passed out like candy to keep these kids in line. This FDA order is way past due!

Jenn

[Spangle]

5. I agree with this! ` From ADHD Family

Ton's of it in my family. <grin> The meds work and they are vital for some folks to have. No different then other meds with side effects. But some of the side effects are not really paid attention to. And that persons on these meds should be watched more closely. (health wise.)

And the knowledge of the risks, should curtail those wanting to put kids on it, "just because." yes, there are some out there. And that group of people really burns me. It makes it difficult for the ones who really need these meds.

I also think that if schools are going to tell parents that their children are ADHD and should see a doctor for meds to help 'control' them, they should take a very extenstive course on what ADHD is and isn't. There ESE teachers should be fully updated on it. They are NOT. THAT would solve alot of the problems right there.

As parents we are treated as 'uneducated' when it comes to our children, their education, their health. Yet, it seems to be ME (the parent) that has to spend time explaining to the educators exactly what ADHD is, what it does, how to teach a child with ADHD, how the meds work, what the meds don't do, etc. Since TEACHING CHILDREN is THEIR FIELD OF EXPERTISE, they should KNOW THIS STUFF!

[Ilsa]

7. I have a son on Focalin XR and he needs it.

The difference in his focus and learning and socialization were like night and day. I'd rather not have to go through the trouble and expense of getting it every month, but his grades went from marginally passing to mostly A's. He's reading more. His comprehension is way up. He gets his work done faster, He is friendlier to other kids.

But I'm glad the FDA is warning us to keep an eye on the medical condition of our kids while medicated for ADD or ADHD.