View Full Version : New warning labels on adhd meds


happycat
02-11-06, 01:02 AM
Maybe someone else already posted this--my appologies if I'm repeating it here:

http://www.cnn.com/2006/HEALTH/02/09/attention.deficit.ap/index.html
Strongest warning suggested for ADHD drugs
WASHINGTON (AP) -- Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said Thursday.

The Food and Drug Administration advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention.

One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to disclose that there was uncertainty about the safety of the drugs.

The FDA is not required to follow the recommendations of its advisory committees but typically does.

"The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Dr. Robert Temple, director of the FDA's Office of Medical Policy, told reporters after the meeting.

Doctors prescribe the drugs to about 2 million children and 1 million adults a month.

Drugs that would have to carry the warning labels are methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The labels for Adderall and Adderall XR, both amphetamines, have included the warnings since 2004.

The Drug Safety and Risk Management advisory committee also recommended that the drugs include a medication guide for patients and parents. The vote was 15-0, with one abstention.

Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Various other companies make generic versions of Ritalin.

Novartis said Ritalin, approved by the FDA in 1955, is safe and effective. A company review of more than 50 years of records shows no apparent increase in cardiovascular problems associated with the drug's use, according to Novartis' medical safety director, Dr. Todd Gruber.

He told the committee that the drug's label advises caution in patients with certain pre-existing heart conditions.

The FDA had asked the advisers to consider ways of studying the drugs because agency data suggested the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks.

The committee, however, quickly began debating whether it should consider new warnings for the drugs rather than the need for more studies.

Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, told fellow committee members they should recommend the black box warning.

Nissen said his suggestion was meant partly to slow what he characterized as the "out of control growth" use of the drugs.

The drugs already carry warnings related to the possible risk they could pose to patients with heart defects.

"We feel this warning is appropriate given our current knowledge of these drugs," said Dr. Gerald DalPan, a division director in the FDA's Center for Drug Evaluation and Research.

The FDA review that found 25 reports of deaths among the drugs' users between 1999 and 2003 also uncovered 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia. Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension.

"There's smoke. Does that mean there's fire?" asked Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research.

"We wouldn't be going through this exercise if we didn't think there was a real possibility of increased risk," Graham told reporters.

The FDA's review found fewer than one reported death or life-threatening injury for every 1 million prescriptions filled for the drugs.

"The decision has been apparently made, and if it's been made, I agree with it, that the reports are not enough to warrant regulatory action," committee member Sean Hennessy said.

Hennessy, an assistant professor of epidemiology and pharmacology at the University of Pennsylvania School of Medicine, ended up voting against recommending additional warnings.

The FDA said the few studies that have looked at longer-term use of ADHD drugs provide little information on those risks.

Also, the agency's analysis of the reports of death and injury only suggests a possible link between the drugs and cardiovascular problems, said Dr. Kate Gelperin, a medical officer in the agency's Office of Drug Safety.

She said the link is not conclusive, nor is it clear whether there is an increased incidence of death or serious injury among people treated with the drugs.

That "is really a question we'd like to have answered," she said.

Sales of ADHD drugs rose to $3.1 billion in 2004 from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.

About 2.5 million children between age 4 and 17 take ADHD drugs, according to federal survey data cited by Dr. Andrew Mosholder, a medical officer in the Office of Drug Safety. The survey found 9.3 percent of 12-year-old boys and 3.7 percent of 11-year-old girls take the drugs, Mosholder said.

Adult use of the drugs alone grew 90 percent between March 2002 and June 2005, he said.

Bob1951
02-11-06, 05:27 AM
Let's see ...

1 methylphenidate/amphetamine accident for every 1,000,000 prescriptions filled.

1 auto accident for every 100 insured automobiles.

I GOT IT ....

Plaster warning labels on both sides of every new car with hp>20 in hugh 2000 pt bold font.

Bob

Scattered
02-11-06, 09:36 AM
Yes, a sense proportionality is sorely needed. I wonder what the risk factors are for taking aspirin or drinking double expressos per million consumers? More research would be great. Educating doctors and the public on risk factors to screen for is also important, but I'm afraid this recommendation will end up scaring both doctors and parents and kid's won't get the meds that could help them. I wonder what the incidents of death would have been if none of those 3 million folks had taken medication? Meds all have some risks -- untreated ADHD also has risks -- you have to be balanced in looking at these things.

Before I started taking meds, I had to call poison control twice in one week -- that was the things that really got my attention and made me face the fact that I needed medication. I wasn't willing to have my 2 year old daughter injured or killed because I kept getting distracted and didn't watch her closely enough. There haven't been any calls since I started meds.

Scattered

kristian59
02-18-06, 02:47 PM
The Food and Drug Administration advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention.


I think an important thing to note about these advisory panels, that hasn't been widely mentioned, is that usually they review a case like this on the recommendation of the FDA. That is the FDA asks them to look at the need for a warning label on certain drugs. But in this case, there was no request from the FDA for this review. This advisory panel took it upon themselves to look into it on their own.

The Diane Rehm show on NPR had an interesting show on this week about this with both sides presented. It's an hour show and a good listen if you have the time. http://www.wamu.org/programs/dr/06/02/16.php


Kristian

roly poly
02-18-06, 05:03 PM
Let's see ...

1 methylphenidate/amphetamine accident for every 1,000,000 prescriptions filled.

1 auto accident for every 100 insured automobiles.

I GOT IT ....

Plaster warning labels on both sides of every new car with hp>20 in hugh 2000 pt bold font.

Bob
This at least puts it in perspective. The news reports don't give it this angle, thanks Bob.

ChloeDharma
02-23-06, 04:24 PM
I think taking medication is something that each person needs to weigh up for their own situation. I personally feel that people need as much information as possible for this.

Hyperion
02-25-06, 12:57 PM
Ok, so I'm in a bit of a smartass mood this morning and feel like taking the opportunity to explain, as clearly and sarcastically as possible, why this is the greatest act of pseudo-scientific stupidity since the pope had Bruno burned at the stake for teaching heliocentrism.



One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to disclose that there was uncertainty about the safety of the drugs.

ah yes, prior to now it had never been disclosed that stimulants could pose a risk of adverse cardiac events. Clearly in the 130 years since amphetamine was first synthesised, doctors were unaware that amphetamines increase heart rate and blood pressure and could be contraindicated in patients with pre-existing cardiovascular conditions. Thank you, Dr. Furburg, for courageously making sure that we are all aware of this, and I expect that you will shortly submit grant proposals to research allegations that water is wet and that bears **** in the woods.



Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, told fellow committee members they should recommend the black box warning.

Nissen said his suggestion was meant partly to slow what he characterized as the "out of control growth" use of the drugs.

Dr. Nilssen, as a specialist on the subject, is certainly more than ualified to testify on the cardiovascular dangers involved. However, as a specialist in the field, he surely must be aware that the average doses of these drugs provide less peripheral stimulation than a cup of coffee.

However, Dr. Nilssen is completely unualified to make any statements as to whether these drugs are overprescribed. He has no background in psychiatry or neuropharmacology, and therefore can neither properly diagnose or treat add, nor does he had the expertise necessary to determine the prevalence of add in the general population or in various age/gender groups. If his recommendation was due to this reason, it should never have been considered in the first place. If his recommendation were due to actual reasons within his specialty, he should have made that more clear.

The FDA review that found 25 reports of deaths among the drugs' users between 1999 and 2003 also uncovered 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.
In this same period of time, it is estimated that 2 million americans died from tobacco use, and nother 400,000 died from the direct effects of alcohol, not including traffic deaths due to drunk-driving.

Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension.
Hmmmm, so that's what happens when you give amphetamines to someone with cardiovascular problems? Wow, good thing they're right on top of this one, because I bet nobody saw that danger coming from a mile away.



"There's smoke. Does that mean there's fire?" asked Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research.

"We wouldn't be going through this exercise if we didn't think there was a real possibility of increased risk," Graham told reporters.

Yes, but black-box warnings are not traditionally recommended when all you have is smoke. In this analogy, smoke is what causes you to recommend more studies, or recommend better methodology for future studies, so as to figure out whether there's really a fire there. I am not aware of any other situation in which the FDa has has an advisory panel recommend a black-box warning when there is "smoke but not fire." To beat this analogy to death, a black-box recommendation is not issued until not only is a fire observed, but its spread becomes a serious threat. Just saying that there is "smoke" is not enough, and to imply that this warrants such extreme measures is unprofessional and honestly borderline unethical.

She said the link is not conclusive, nor is it clear whether there is an increased incidence of death or serious injury among people treated with the drugs.

That "is really a question we'd like to have answered," she said.
Hmmm, now there's an interesting idea: study the situation, get answers to some uestions, and then decide whether to issue warnings. I mean, just because it's the standard for every other scientific field since the renaissance, doesn't mean that this advisory committee actually has to abide by it. Sort of like how just because one is a cardiovascular specialist, this shouldn't prevent him from making a definitive statement about the prevalence and possible overmedication of a psychiatric disorder.



Incidentally, a story ran in today's Washington Post about a new study on abuse and addiction to stimulant meds. It was only at the bottom of the first column that the author chose to mention that add medication reduces substance abuse problems in add patients, and it was not until the end of the article that mentions that the study was paid for by Eli Lilly, the maker of Strattera. I wouldn't be surprised if some of this hoo-ha about the dangers of stimulant meds might be an effort by Lilly to tout the safety of its drug.

The thing is, if these were actual valid medical concerns, I would have no problem with them. There is nothing wrong with Lilly doing actual research into the safety of different medications, and in some ways it is beneficial to us all to have competing companies scrutinising each others' drugs. The problem is that in this situation, the conclusions don't seem to bear any actual resemblance to most of the scientific evidence. It seems more akin to Stephen Colbert's "feelings over facts" meme. Some doctors who do not specialise in this field are voicing essentially "gut feelings" about these drugs. That's fine, and if it spurs new research it could be useful, as even if the new research disproves their hypothesis, we still might learn something new. However, when people start misrepresenting unualified opinions as having more validity than 70 years of studies, case reports, and physician observations, something is seriously wrong.

I do not know why this advisory panel chose to do this. I only know that whatever their reasons were, they don't seem to be based on sound medical science, leading me to wonder whether this is simple incompetence or whether there might be actual ethical lapses.

Can amphetamines cause cardiovascular problems, especially in people with pre-existing conditions? Yes. We've known about this for decades. Unless there is a major new finding, along the lines of discovering a new metabolite or method of action for this drug that is not already known, or unless studies are showing statistically significant rates of adverse cardio-vascular events in people without a pre-existing condition who take this medication, then this advisory warning doesn't even rise to the level of intellectual masturbation.

Scattered
02-25-06, 04:24 PM
Hyperion, I very much enjoyed your smart a......uh, I mean your critique!:D

Thanks,
Scattered

PS: Critical thinking seems at times to be a vanishing skill.

katatak
02-26-06, 04:43 PM
Maybe someone else already posted this--my appologies if I'm repeating it here:

Thursday.[/b]

Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, told fellow committee members they should recommend the black box warning.

Nissen said his suggestion was meant partly to slow what he characterized as the "out of control growth" use of the drugs.

Does he not notice that adults have breen added to teh diagnotic critrera for ADHD? Does he not compare this numbers against the increase in diagnosis? This smacks of a set up by some unknown group.

I would expect more from someone in his area of research.




The FDA review that found 25 reports of deaths among the drugs' users between 1999 and 2003 also uncovered 54 cases of serious cardiovascular


Odd that these casess are of people who *used* these drugs, not people who's cause of death was attibuted to these drugs. This is more than just a minor oversight in his observations.



The FDA's review found fewer than one reported death or life-threatening injury for every 1 million prescriptions filled for the drugs.

"The decision has been apparently made, and if it's been made, I agree with it, that the reports are not enough to warrant regulatory action," committee member Sean Hennessy said.

Hennessy, an assistant professor of epidemiology and pharmacology at the University of Pennsylvania School of Medicine, ended up voting against recommending additional warnings.

Finaly, someone with some common sense.

The data is out there, it has to be mined properly. We do know who takes these drugs and causes of death are alwyas reported. It may not be conclusive but no scientist anywhere ever makes a statement that is final and conclusive. They always say, we believe that, or we think that, or we think the evidence supports....

There never will be "conclusive" proof.

We've heard that the sky is falling once to often and now we just don't believe it anymore!

Cheers,
Katatak

Hyperion
02-27-06, 02:28 AM
Does he not notice that adults have breen added to teh diagnotic critrera for ADHD? Does he not compare this numbers against the increase in diagnosis?
It is entirely possible that as a cardiologist, Dr. Nilssen is simply not familar with the diagnostic criteria for add. There is certainly nothing wrong with this, any more than it would be wrong for a non-MD therapist to be unfamiliar with defibrillators and angioplasty, but this is why we don't ask them for their opinions on the effectiveness, prudence, or possible overuse of various cardiac procedures.


Odd that these casess are of people who *used* these drugs, not people who's cause of death was attibuted to these drugs. This is more than just a minor oversight in his observations.

Especially in light of findings that many of these patients had pre-existing cardiovascular conditions. This is an excellent example of the adage that correlation does not imply causation. Given that the incidence of adverse cardiovascular events in persons with these pre-existing conditions is far greater than the incidence of adverse events in patients taking adderall, this is beginning to sound a bit like blaming food poisoning as a cause of death and just ignoring the five gunshot wounds.



We've heard that the sky is falling once to often and now we just don't believe it anymore!
There are actual, real situations of "sky is falling" events, like Merck's Vioxx issue a few years back. But when these things happen, the evidence is usually pretty damned conclusive, and there is widespread agreement. In the Vioxx case, for instance, there were mounting anecdotal reports of problems, which led Merck to formulate a study on the subject, which is a bit more difficult than it sounds due to safety and ethical issues, and the study showed such profound effects that the independent observers called a halt to it midway through out of concern for the health of the participants. Once this happened, the evidence was simply overwhelming that this danger existed, and Merck immediately notified the FDa and pulled Vioxx from the shelves. This is what a real medical emergency looks like.

Scattered
02-27-06, 03:29 AM
<TABLE class=contentpaneopen><TBODY><TR><TD vAlign=top colSpan=2>Hallowell just put out this statement on the subject of warnings on these meds, so I thought I'd share it.

Scattered<!--StartFragment -->

Recently an advisory board to the FDA voted 8-7 to advise the FDA to add a black box label to Ritalin, Adderall and similar stimulant medications used to treat ADHD. The panel based its decision on an FDA report that found 25 children and adults had died suddenly from 1999 to 2003 after taking ADHD drugs.
Dr. Hallowell believes that the recommendation is not sound, and provides this response:

"It is strange that they would issue (a recommendation for) a black box warning now, without any new data. I think it reflects the extreme uneasiness so many people feel around stimulants. However, aspirin causes far more damage every year --deaths due to stroke and GI bleed, not to mention that dozens of people commit suicide with aspirin every year. None of that happens with stimulants, and yet people continue to feel extremely edgy about stimulants -- even though they have been in use since 1937.

In my own experience of prescribing stimulants for about 25 years now, I have found them to be very safe, and also very effective, as long as they are used properly. "Used properly" means that side effects are watched for, and if they do occur the dose of the medication is reduced or the medication is discontinued altogether.

The most common side effect is appetite suppression. This is okay, but if weight loss occurs the meds must be adjusted or stopped. Other side effects can include: insomnia, elevated blood pressure, elevated heart rate, abnormal heart beats and rhythms, tics and twitches, personality changes, loss of creativity and spontaneity, paranoia, headaches, nausea, and sedation. ALL of these are reversible by lowering the dose of the medication or stopping it completely.

The key is educating the patient and carefully monitoring the medication. Do a risk benefit analysis before starting the medication. What are the "side effects" of NOT taking it?

Often people ask me if I "believe in" Ritalin. My reply is that it is not a religious principle. It is a medication and sould be dealt with on a factual, scientific basis.

I have never had a patient suffer a lethal side effect (thank God) nor anything close to it. I have had to discontinue the medication, perhaps once out of every 10 times I prescribe it, due to side effects. So, these meds are far from perfect. But, they are the best medication option we have and are very safe when used correctly.

That they are not perfect is why I stress the use of non-medication treatments so forcefully. Just identifying strengths in a patient has a potent therapeutic effect. A somewhat new non-medication treatment that I think is really promising is cerebellar stimulation through physical exercise. New data is coming out showing that this modality could be a great breakthrough."

Edward Hallowell, M.D.</TD></TR></TBODY></TABLE>