Article below:

http://news.aol.com/topnews/articles/_a/new-warning-for-attention-deficit-drugs/20070221143209990001?ncid=NWS00010000000001

WASHINGTON (Feb. 21) - Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday's announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

Affected Drugs
The FDA announced its order applies to 15 drugs:

· Adderall Tablets
· Adderall XR Extended-Release Capsules
· Concerta Extended-Release Tablets
· Daytrana Transdermal System
· Desoxyn Tablets
· Dexedrine Spansule Capsules and Tablets
· Focalin Tablets
· Focalin XR Extended-Release Capsules
· Metadate CD Extended-Release Capsules
· Methylin Oral Solution
· Methylin Chewable Tablets
· Ritalin Tablets
· Ritalin SR Sustained-Release Tablets
· Ritalin LA Extended-Release Capsules
· Strattera Capsules

very interesting read- thx :)

anyone know of any cases that would resemble those advisories ? more so the schizophrenia symptoms than any others ...

I just wonder why Strattera is included even it's not a stimulant.

I think that the advisory may be well founded if the scientific data backs it up. If there is potential harm it should be disclosed. But also, it has to be weighted with the real threat of harm.

But my real concern is, the lobbying from the anti ADD groups to get the black box label on the meds. I understand a parent that lost a child lobbying to get the warnings but groups like the Antipsychiatry Coalition and the fringe Christian groups?? Don't even get me started on the Church of Scientology.

Right now in Washington, a lot of decisions, be it ADD drugs, Gardisil, Plan B, and so on are politically driven. I understand the politcs behind Gardisil and Plan B since it deals with the scary subject of SEX and the conservative nature of administration having issues with the subject, but what about the ADD drugs?

i have taken anywhere from 2.5 to 105 mg of dexedrine daily since I was 6 years old, and the point of this is probably to people it applies to. I am 26 and became psychotic within 3 days of taking any antidepressant on the market even Sinequan, Trazodone and Remeron which all make most people sleep. Strattera and effexor were psycho pills for me too. Where's the warning for that??

Way to go mspen! I become hysterically, non-sleeping, mixed-episode, rapid-cycling hypomanic when prescribed SSRI/SSNRI medications and took them for YEARS before anybody told me that was was happening to me was not a sign of normalcy at all!

Where is the warning label on those commonly prescribed antidepressents reading:

"WARNING! A larger percentage of the population has one form of bipolar disorder or another than originally thought. This medication may induce hypomanic to severely manic symptoms in undiagnosed bipolar patients. Please become highly knowledgeable about this disorder in all its forms, because many psychiatrists are not conversant in all forms of bipolar behavior. Take this medication at your own risk"

Hrrrmph, snort, phooey.

And Attention? If you know a pincushion who is mainlining that way? You need to find a better class of people to associate with or move to a different area :(.

These announcements and warnings are nothing more than a C.Y.A. blanket statement to keep the heat off the FDA and the companies making the meds.


J

These announcements and warnings are nothing more than a C.Y.A. blanket statement to keep the heat off the FDA and the companies making the meds.

J
Agreed - +1

I blame adderall.

This is just the fda covering their own butts. In this law suit happy age, everyone is walking on egg shells. :( The fda has known about these potential side effects for a long time. Stimulant medications have been around for decades.

I just wonder why Strattera is included even it's not a stimulant.Good question as my son ended up in the emergency room on that stuff and had an EKG. No more Strattera.

Momofadder

I just wonder why Strattera is included even it's not a stimulant.
Its probably included due to the increased risk of suicidal thoughts in juviniles, and the extremly rare casees of liver problems. The actual studys done on Strattera showed that 4 out of 1000 juviniles had increased suicidal thoughts. Since the study, there have been a couple people that ended up with some serious liver problems. This is a hypochondriac world, and everyone seems to like to emphasize the bad stuff without taking the other side into consideration.

very interesting read- thx :)

anyone know of any cases that would resemble those advisories ? more so the schizophrenia symptoms than any others ...
I've been taking adderall for about 7 years now, and it definitely causes bipolar symptoms at times, but nothing out of control, I'm usually more happy than anything. I used to occasionally abuse my adderall, just to have some fun off of it and not always think ofit as "medication" that i needed to get through the day. This one time, however, I went a little overboard on the abuse, and it was fun for a while, but then I became extremely paranoid, and I suppose in ways, schizophrenic. I started hearing voices and what sounded like someone walking up my stairs to my room (i have wood floors so it was quite a loud series of creaking steps). I couldn't go 5 minutes without jumping up to see if somebody was really coming up or not, and after an hour or 2 it stopped, I crashed, and felt like crap for the rest of the day. Needless to say, I stopped abusing it.

@chad - I've heard of a ton of cases of schizophrenic reactions to misuse (missed nights of sleep, too huge a dose etc), I seriously wonder tho if the warning is because of misuse and not regular use... if noone on this forum has had a reaction like that, it could be that kids are going into the emergency room after misusing their meds and claiming they didn't? I cant remember who it was (nzkiwi?), but the person who said it was prolly the FDA covering their *** sounds like a good answer

Its called amphetamine psychosis, everyone can get it.

@D.B. Cooper
anyone at regularly prescribed doses ? or are we talking pulling an all nighter here and there?

@D.B. Cooper
anyone at regularly prescribed doses ? or are we talking pulling an all nighter here and there?Anyone in theory if they're imbalanced to begin with but yeah staying awake to long definetly contributes to it.

Its called amphetamine psychosis, everyone can get it.

I can't speak for every one but I can speak for myself and yeah I more than get it how ever the effects are not related to the amphetamines them selves. You get closer to it below.

Anyone in theory if they're imbalanced to begin with but yeah staying awake to long definetly contributes to

Staying awake has like every thing to do with it.


Please refer to the following source.

phychiatric times (http://www.psychiatrictimes.com/p980301b.html)

This same pattern of mental deterioration that mimicks psychotic symptoms appears in several more systematic studies of sleep deprivation and extreme sleep debt. Thus, prolonged sleep deprivation does lead to the appearance of serious mental symptoms. In addition, even moderate amounts of sleep deprivation can lead to losses in mental efficiency that can threaten public and personal safety.

***End Quote

Ya know mild to moderate sleep deprevation looks a lot like inattentive ADD so if some one is ADD and sleep deprived then the ADD would get worse. Is it any wonder?

Begin Source Quote***

Among the common consequences of a large sleep debt are attentional lapses, reduced short-term memory capacity, impaired judgment and the occurrence of "microsleeps."

A microsleep is a short period of time, usually between 10 seconds to a minute in length, in which the brain actually enters a sleep state, regardless of what the person is doing at the time. The affected individual often does not know that this momentary blackout has occurred. The effects of these microsleeps combined with attentional lapses, however, can be dramatic.
***End Quote

So the psychosis isn't the stimulants themselves but the fact they allow people to stay awake longer than what is natural for them.

People in the manic phases of bi-polar can also stay wake days with little or no sleep. In bi-polar one mania can lead to psychosis, it is known that people with bi-polar 2 are at increase risk of going to bi-polar one if left untreated. The difference is in severity, bi-polar 2 normally do not have psychosis with their mania however if not treated they can end up crossing that line. Hmmm perhaps the psychosis is caused not by the bi-polar itself but the sleep deprivation. Our brains need sleep to work properly if we deny our brain the necessary sleep then it will tweak your world. As far as I can tell it doesn’t really matter what causes the sleep deprivation either.


I do hope this help clear up any misconceptions going on here

@attention - we all know that intense amounts of illegal stimulants will give schizophrenic reactions (schizophrenia is actually just too much dopamine in the brain, and too much stimulants = too much dopamine so its prolly similarly triggered) -- but the thing here is, would a prescribed dose actually increase dopamine levels to the same degree as the illegal use of stimulants (like your friend), and if not, then why are they adding this warning other than to create FUD (fear/uncertainty/doubt) that treating ADD poses the same risks as using illegal stimulants for weeks of sleepness nights--The thing is -- everybody is wired a little bit different. For most folks using a prescribed dose, no, it won't trigger these problems. But for some percent of the population they will. On a different drug, but applying the same principal, when I took a low dose of Prozac, I had a couple of hallucination type experiences. That's definately not common, but I sure would have liked more of a heads up that it was a possibility for a small minority. Some folks are just very reactive to medications -- just like some people can't handle even one beer.

Scattered

I take dexedrine so I hope this doesn't seem anti-psych but Adderall seems to be the new Prozac. People without ADHD can get an Adderall trial in less than 15 minutes of a GP visit in this area. The anti-psychs call it the "Adderall boom" and I agree with the fact that A lot of people who don't need it can and do obtain it.

I take dexedrine so I hope this doesn't seem anti-psych but Adderall seems to be the new Prozac. People without ADHD can get an Adderall trial in less than 15 minutes of a GP visit in this area. The anti-psychs call it the "Adderall boom" and I agree with the fact that A lot of people who don't need it can and do obtain it.Adderall is by far the second most popular recreational drug right now. Its all about name brands adderall, oxycontin, xanax. I've heard of someone doing an experiment and offering your usual college student frat boy a desoxyn or an adderall and of course he took the adderall.

People are idiots even when it comes to recreational drug use...especially when it comes to recreational drug use.