View Full Version : Hallowell's Response to recommended black box warning


Scattered
03-28-06, 11:26 AM
Stimulant Medication Controversy 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.

You can find this article and others by Hallowell and Ratey at:


http://www.allaboutminds.com/index.php?option=com_content&task=view&id=47&Itemid=56

goughy
03-28-06, 04:53 PM
Stims are geeting some serious bad press in australia at the moment too. Since Ritalin was added to our government pbs system (making it cheaper - and low income health card holders (me) can get ritalin ir for about $6au) the prescribing of it has gone up 10 fold.

While last nights newsstory initially said it was a med for adhd, the first child they featured they said was on ritalin for hyperactivity. Maybe they didn't give the whole story and he has adhd or maybe he's mis-prescribed. It's something I do feel is happening in aus.

My best friend was quite concerned when he found I was going to try stim meds. His sister works with child health (or something) and told him she sees countless kids on ritalin that are like total zombies. Sounds to me like mis-prescribing, especially after all I've read about the use of stim meds and their effectiveness.

In aus a general practitioner but usually a paediatrition (don't knock my spelling) can prescribe ritalin up until the age of 18. At the age of 18 it becomes more complicated. But considering how invloved and complicated it can be to diagnose adhd at times, are some docs not being thorough enough.

Should these kids be visiting psychiatrists for medication rather than docs. I know I had to. And at my age the govt keeps a much tighter reign on it's use.

I live in a city of about 100,000, and was told by my family doctor and 2 psychologist that I wouldn't find a psychiatrist in town that would have enough knowledge/experience with adhd to help me. I have to travell 2 hours to see my psychiatrist (which is a pita).

Am I getting off track here. I don't know.

I can understand why people may need to be wary of stim meds, but pushing this fear into everybody will accomplish nothing except make parents whose kids need them less likely to want to try them. They may also may become afraid of a social stigma being attached to their kids if they use them; what kind of social stigma is gonna be attached to an adhd child not being treated. I'm mostly innatentive and I had a bugger of a time through much of my school with the other kids.

scuro
03-28-06, 06:48 PM
You should be leary of all meds. Then again, theraputic levels of stims are probably the safest and most effective class of drugs out there.

stanzen
03-29-06, 02:24 AM
The public and media aversion to stimulant medications seems to show an irrational ambivalence to the theraputic use of potential drugs of abuse.

I suspect this is an irrational response, because there is no new or exceptional evidence of harm from stimulants. These drugs have had a long, safe track record, and recurrent controversies (for example, they are no longer prescribed for weight loss, once a popular use).

Intermingled with this increase in salience and building apprehension are parental concerns for medication of children.

This is backlash brewing.

Preceived Risk= Outrage + hazard. to quote Sandman.

There seems to be have been a backlash against an increased prevalence of autism (partially due to an expansion of case-ascertainment in US schools in the early 1990s) expressed in the blame of vaccines as a cause.

The scientific evidence is also lacking for harm due to thimoseral (an ethy-mercury perservative) contained in some vaccines.

Vaccines are traumatic -- for parents. Its painful to the parent to take a child and have them harmed intentially by a painful needle injection; a salient event, that is somewhat out of control of the parents, who proffer their child to the business end of a hugh, bureaucratic medical system.

Fine, if you trust the system to do good. But what if you see the system as antagonistic, or uncaring?

In this context, vaccination seems a memorable precursor and cause of the later diagnosis of autism. Any scientific evidence to the contrary is just another untrustworthy assertion by the suspect medical authorities.

= Outrage implies the hazard.

ADHD may be analogous.

Expanding case-ascertainment and diagnosis of ADHD by psychologists and psychiatrists (always suspect specialties in any era) at school (that wholly alien place where kids are fed all sorts of strange ideas).

All the press of how arbitrary a diagnosis is for ADHD lends an aire of uncertainty. And the introduction of medications that are potential drugs of abuse.

What can make parents more out of control than a drug of suspect safety which is potentially addictive given to their children by untrustworthy authorities?

My take before easing off to sleep.

Matt S.
03-29-06, 10:23 AM
The FDA wants to be "jerks" about certain drugs yet this country legalizes alcohol and tobacco which are two of the most harmful and addictive substances available today yet there is some misinformation or assumption that people with ADHD are unintentionally getting "hooked" or something... there has always been a bad rap there... I take dexedrine and when i told my past employer... she stated "you aren't fat, what do you need that for?"... misinformation and bad reputation... nothing more