View Full Version : New warnings on ADHD drugs


Andrew
08-22-06, 07:26 AM
By Susan Heavey Mon Aug 21, 8:26 PM ET

WASHINGTON (Reuters) - Several drugs to treat attention deficit hyperactivity disorder must include new warning information about the risk of heart problems and psychotic behavior, U.S. health officials said on Monday.

The drugs, which include GlaxoSmithKline Plc's Dexedrine and Novartis AG's
Ritalin, must include a warning about the possible risk of sudden death and serious heart problems, Food and Drug Administration spokeswoman Susan Bro told Reuters.

The drugs, stimulants that can raise blood pressure, must also include warnings about the risk of behavioral problems such as aggression and mania, she said.

Bro could not confirm whether other ADHD drugs -- Johnson & Johnson's Concerta and Eli Lilly and Co.'s Strattera -- also were ordered to carry the warnings.

Strattera already includes a caution about suicidal thoughts, while Shire Plc's Adderall already carries a warning that misuse can cause heart problems.

The FDA's decision comes months after two separate panels of outside experts offered conflicting opinions on whether the risks warranted the strongest warnings possible -- a so-called black box.

FDA's Bro could not confirm whether the heart warning was boxed. But a letter from Glaxo made public earlier on Monday advising doctors about the new warnings said the heart caution was a boxed warning.

Other non-boxed warnings about psychotic behavior, stunted growth, seizures and vision problems also were included, Glaxo's letter said.

Holly Russell, spokeswoman for the British drugmaker, said Glaxo agreed with the FDA's request to add the warning language and complied with the agency's recommended wording.

Other drugmakers did not immediately return calls seeking comment.

In March, FDA advisers said new information about the risks should be added to the labels for attention deficit drugs. The outside experts stopped short of supporting a boxed warning, saying they did not want to scare off patients or their parents.

A different FDA panel in February recommended black box heart-related warnings but said it was unclear if the drugs caused heart-related complications.

Some doctors have expressed concern that new warnings could dampen use of the medicines, which the FDA has estimated see about 1 million prescriptions for adults and 2 million for children each month.

Critics say many of the prescriptions are unnecessary and that the drugs are over used.

FDA's Bro said the agency began contacting Glaxo and Novartis about the new warning requirements in May.

That same month, Canadian health authorities publicly warned people with high blood pressure, heart disease and other medical problems to avoid taking medications for ADHD.

SnappyCloud
08-22-06, 07:48 AM
At least nothing new was discovered and the requirement is just for labeling of possible effects. A lot of this is to cover their butts and possibly to satisfy the anti-drug folks.

Come on guys, even the use of aspirin carry the risk of internal bleeding.

All I know is that stimulants lower MY blood pressure, among any bad thing they may be doing to me.

loversinc
08-22-06, 09:30 AM
isn't it lucky that the research is continuing and new safer treatments are being worked on.

Hyperion
08-22-06, 10:47 PM
A lot of it is covering for Dr. Nissen's asinine unqualified blabberings. It's better to do this than to admit that they nominated a cardiologist who thought he was a psychiatrist to chair one of their committees.

I think that we should all take a moment to thank the FDA for reminding us that people with heart conditions or a history of psychotic symptoms shouldn't take psychostimulants, as this was clearly a difficult task for the Federal Duh Administration. I'm sure that it was well worth their time to warn people that stimulants can increase your heart rate, rather than looking into, I don't know, moving Plan B over the counter, a decision that has been pending for far longer and the paperwork for which was submitted long before this whole brouhaha began.

That being said, I shouldn't be quite so glib. I was just speaking with my doc today to get my prescription for this month, and I mentioned this (not really a problem for me, at my age and with no risk factors for heart problems, the far bigger danger is in not taking meds and forgetting to look both ways before crossing the street), pointing out that it was fairly ridiculous, and he did point out that he had a patient in his 50s who had to beg his cardiologist to give him the ok to take it, due to a cardiovascular condition. The man had looked at the risks and benefits, and decided that it was better to take the meds. That being said, there was a very real risk for the man, so I suppose that it does bear remembering that it's not as funny for some people.

That being said, it wasn't like the man needed the FDA to tell him that stimulants would increase the risks. It wasn't like my doc needed the FDA to warn him. The cardiologist didn't need the new FDA warning to know that stimulants could increase his heart risk. Most people who graduate from medical school learn that stimulants can increase heart rate and blood pressure, and therefore may be contraindicated in people with certain cardiovascular conditions. Most people who have never been to medical school probably also know this.

Hyperion
08-24-06, 07:01 PM
Haha, apparently the FDA isn't as dumb as I thought, I retract my comments on Plan B, they just approved it today.

loversinc
08-25-06, 02:24 PM
aspirin.. like ritalin helps a lot of people

both also kill rather more people than i'd like.

Scattered
08-25-06, 02:38 PM
I was initially against the warning, but you know what, since I've recently experienced a some very serious side effects from another medication (Prozac) which I didn't realize where even a possibility with that particular medication even after carefully reading all the handouts and several books on it, I'm for big obvious labels. It may not be needed for everyone, but if you're someone who needs to know that information because you're in a higher risk category it's better to have it shown more obviously (ADDers especially have been know to not bother with the fine print). Doctor and patients need to be better educated that a warning means that it is important to assess the risks for that individual -- not write off the whole medication. My two cents!

Scattered

VisualImagery
08-25-06, 02:45 PM
aspirin.. like ritalin helps a lot of people both also kill rather more people than i'd like.
I would like to see the data on deaths directly attributed to these medications. Your data would be for the UK. Thanks! Question-do they kill them because of misuse by the person or is it a direct dosage link with the death? There are many extraneous variable to consider when looking at the morbidity and mortality statistics. Pre-existing conditions, patients not revealing other meds/street drugs etc. So I always like to see the data and how they determined cause and effect. This is difficult because it is unethical to test human beings to see what the fatal doses of aspirin and ritalin are-or any other drug for that matter.

I think the black box warnings are necessary because so many people are not good medical consumers. The only way they will be aware is if the info is in a black box with flashing lights.

After my experience with serotonin syndrome-I would like to see a black box about it as well on the drugs that interact causing it.-some forms can be fatal-MAOI's and SSRI's. My pharmacist said it was so rare-my reaction-that no one thinks about it. A warning did not come up on their computer at the pharmacy-weird though-I found it on the interaction checker on their pharmacy website! I suffered for a long time while taking trazodone with my SSRI's-and realize I spent a lot of money on medical care that I can now directly relate to the interaction.

I would just hate to see people not take a drug that could really help them because the black box scares them-and they don't take the time to read more about the med and make an informed decision. Perhaps the %of risk associated or number of people per 1,000 affected or something like that would put the risk into perspective.

RADD

Imnapl
08-25-06, 05:28 PM
I would like to see the data on deaths directly attributed to these medications. Your data would be for the UK.Hey! My very strong gene pool is from the U.K.!

VisualImagery
08-25-06, 07:15 PM
Apple-what does that have to do with the deaths? I do know you swim in the deep end :) . I just need a meta-analysis of causes of death or something.

I am Celtic, Gaelic, Welsh, with some other stuff thrown in-perhaps Comanche and Huggenott. So my genes might be related to you genes-OMG!

Hyperion
08-25-06, 07:31 PM
After my experience with serotonin syndrome-I would like to see a black box about it as well on the drugs that interact causing it.-some forms can be fatal-MAOI's and SSRI's. My pharmacist said it was so rare-my reaction-that no one thinks about it. A warning did not come up on their computer at the pharmacy-weird though-I found it on the interaction checker on their pharmacy website! I suffered for a long time while taking trazodone with my SSRI's-and realize I spent a lot of money on medical care that I can now directly relate to the interaction.
OH MY G_D!!!! I cannot believe that your pharmacist let you walk out the door with and SSRI and an MAOI together. Holy !@%#*@&)&@26*$%. And for him to say that serotonin syndrome is a "rare reaction" with that combination just underscores his incompetency. Serotonin syndrome is the reason why those meds should never be combined. In fact, it's a reason why two strongly serotonergic drugs should never be combined at all, or a serotonergic drug and an MAOI should never be combined. Unlike dopamine, excess synaptic serotonin levels can cause serious and possibly fatal side effects.

aspirin.. like ritalin helps a lot of people

both also kill rather more people than i'd like.
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I would just hate to see people not take a drug that could really help them because the black box scares them-and they don't take the time to read more about the med and make an informed decision. Perhaps the %of risk associated or number of people per 1,000 affected or something like that would put the risk into perspective.

I don't have the numbers per thousand people, or for methylphenidate specifically, but I do know the numbers for all ADHD meds combined over the past five years.

Approximately 180 million one-month prescriptions were filled in that time period. During that period, 25 people who were taking the medication died, and somewhere in the neighborhood of 50-something people had severe adverse reactions that required hospitalization.

So .14 deaths per million prescriptions, or .00014 deaths per thousand prescriptions written. The odds of death per prescription would be .00000014. Now keep in mind that this is presupposing that all 25 deaths were caused by the meds, or that the meds at least played a role, which is not necessarily the case. All that was reported was that they died while taking it. Also, it is not clear how many of these people may have had specific risk factors such as certain cardiovascular conditions. If some of these deaths were unrelated to the meds, and some persons had risk factors, then the odds per prescription would be even lower.

However, even if we assume for the sake of argument that the meds caused all 25 deaths, and that all 25 people were otherwise healthy, normal individuals, then that still means that the odds that the prescription that I picked up this week will kill me are roughly 1.4 in 10 million. For reference, the odds that I might die of cancer at some point in my life (presuming average risk factors) is 1 in 550.

Now lets look at total deaths. It is true that the 25 people who have died from ADHD meds in the past five years is far higher than the number of people who have died from marijuana (0). On the other hand, alcohol poisoning alone (not counting traffic accidents or the like) kills between 50,000-100,000 people annually, for a total of 250,000-500,000 people in the same time period. Tobacco kills between 400,000-500,000 people per year, for 2,000,000-2,500,000 people in the same time period.

But let's look at the math most favorable to the theory that ADHD meds are dangerous and will kill you: let's look assume that it's the same 3 million people each month taking these prescriptions, even though that is unlikely to be the case. We'll also continue to assume that the meds caused each death and that each person was perfectly healthy with no risk factors. This means that out of these three million people taking the medication, 5 died each year. This does put us slightly above the one in a million mark, at 1.67 per million, or 1 in 598,000 but the odds are still fairly high. There are a number of reasons why this number isn't valid, however, but it's far more than I want to get into in this post.

So looking at death's per month's prescription, it's somewhere between slightly more than 1 in 10 million and 1 in 598,000, with the odd most likely closer to the former value.

VisualImagery
08-25-06, 07:51 PM
OH MY G_D!!!! I cannot believe that your pharmacist let you walk out the door with and SSRI and an MAOI together. Holy !@%#*@&)&@26*$%. And for him to say that serotonin syndrome is a "rare reaction" with that combination just underscores his incompetency.
Sorry I was not clear and gave you such a scare hyper. I walked out with trazodone and different SSRI's over the years. Despite telling my docs I couldn't relax, I was so tense etc. this did not resolve with alprazolam either.

It got really bad when I started on ADD stims-and then Relpax for migraines. Ataxia so bad I was falling down as school. And off the couch at home. Had an MRI-Completely normal :rolleyes: . So, the worse I felt, the more they increased my zoloft, the more zoloft, the more symptoms, the more symptoms, the more zoloft-I could barely function at the end. I was drenched in sweat, dizzy all the time, could barely handle stairs, my heart rate was always high, I had chest pain, and the mental confusion? OMG It was awful. They really were beginning to think I was a nut case.

I stumbled on the interaction on BCBS website when I used the interaction checker. Weaned off the zoloft after doc suggested I didn't need it-she was going to dx bipolar-I freaked when she gave me riperdal. That is when I found this article after checking interactions. http://www.uspharmacist.com/oldformat.asp?url=newlook/files/feat/acf2fa6.htm

It seems the combination of drugs I was on worked to make it pretty darn bad. Over 2 years I went from 25mg zoloft to 150mg. And from 5mg ritalin 2x a day to 54 Concerta and 20mg Ritalin 3x day. The trazadone stayed at 50mg the entire time. It is the big culprit in this mix.

The reaction is now in all my medical records-I made sure of that and on record at the pharmacy. I am now off trazodone-but need to find a good sleep med for my fibromyalgia

I hope this helps clear it up H.
RADD

loversinc
08-26-06, 02:09 AM
if you type in deaths from ritalin US. or deaths from aspirin US.. etc you will find plenty of informtion

Imnapl
08-26-06, 04:39 AM
I tried to search deaths from ritalin US and the top hits led to the ritalindeath site. :confused:

VisualImagery
08-26-06, 12:37 PM
Hyperion's post is excellent and uses valid data. Did you read it loversinc? I could get cancer several times over compared to the chance of dying from ritalin. :D Would rather risk that than have cancer.

Scattered
08-26-06, 09:34 PM
After my experience with serotonin syndrome-I would like to see a black box about it as well on the drugs that interact causing it.

I checked with my pharamcist about the combination of Maxalt MLT for migraines and the Prozac I was taking to be sure they were okay together. He looked it up and said there was a low risk of serotonin syndrome but that it should be fine. A couple weeks later I read a new FDA warning against taking that exact combination because of the high risk of serotonin syndrome.:faint: Fortuantely, I didn't develop that!

Scattered

VisualImagery
08-26-06, 10:50 PM
I think I am very sensitive to certain types of drugs and these must have been on my hit list. It was the combo, not any of the drugs alone. Dang my body. Wish we could predict that stuff with a blood test or something.

Scattered
08-26-06, 11:51 PM
I think I am very sensitive to certain types of drugs and these must have been on my hit list. It was the combo, not any of the drugs alone. Dang my body. Wish we could predict that stuff with a blood test or something.Yeah, this "trial of medication" is not the ultimate answer, eh?

Scattered

Squirrel
08-27-06, 06:43 AM
I tried to search deaths from ritalin US and the top hits led to the ritalindeath site. :confused:That's why I use scholar.google.com ;)

Imnapl
08-27-06, 01:02 PM
That's why I use scholar.google.com ;)I had no idea! Squirrel, thank you so much.

Squirrel
08-27-06, 04:55 PM
No probs, I think I would have been slaughtered for turning in essays with material pulled from "regular" google searches :D Mind you, a lot of the hits will come up on PubMed too. Speaking of which: There's a Firefox extension called Biofox that adds a PubMed search to the context menu.

Dang my body. Wish we could predict that stuff with a blood test or something.Maybe pharmacogenomics will sort that out eventually - they'd take a sample, check for any funky genetic variants you might have and pick your meds accordingly. Might only be feasible for more common polymorphisms though.

Imnapl
08-27-06, 05:48 PM
Well, they have come a long way with anesthesiology.

Biofox? Keep 'em coming, Squirrel.