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51 deaths ADHD drugs ...



 
 
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  #71  
Old February 11th 06, 03:02 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...


"Peter Bowditch" wrote in message
...
"vernon" wrote:


"Bob Kaplow" wrote in message
...
In article , Mark Probert
writes:
"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."

How many people died over the same period of Tylenol (or the many
generic
equivalents) overdose? How many more suffered life threatening
complications, or are now on a wait list for an organ transplant from
Tylenol. And why aren't these same people SCREAMING to pull Tylenol off
the
market.



It takes a lot of Tylenol for a while to cause big problems. These
people
are usually in bad shape and Tylenol a "substitute" death.
No pain reliever is the safest, but next to that Tylenol is the safest
pain
reliever.


Another thing of which you are ignorant. It takes two packets and two
hours. Have you ever
watched someone having charcoal forced into their stomach to soak up
paracetamol? Have you
ever seen how easy it is to get immediate treatment in a crowded ER by
saying the words
"Panadol" and "overdose" to the triage nurse? Have you ever heard a doctor
say something
like "It was only about 24 tablets and we got to it quickly, so I am
hopeful that no real
liver damage was done"?
--


Gee 24 tablets.

Keep all medications out of the reach of children and mentally deranged.

What pain reliever is safer (not safe) and under what circumstances?

For average adult people.
Compare two tablets every four hours and allow 8 hrs sleep, for five days.

For chronic pain, still relatively normal adult average people, maximum six
months.

Which is safest. (not safe) This is a test of your knowledge for which you
have spouted.

Ibuprofen
Aspirin
Acetometaphen
Motrin (8hr span)

Yes, as I stated, taking no pain reliever is the safest solution.


  #72  
Old February 11th 06, 03:07 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...


"JanD" wrote in message
news:M0eHf.760166$x96.268947@attbi_s72...

"vernon" wrote in message
g.com...

"JanD" wrote in message
news:y%5Hf.790835$xm3.47596@attbi_s21...

"vernon" wrote in message
ng.com...

"Brad_Chad" wrote in message
oups.com...
If conventional doctors had any moral integrity, they would have at
least given all their ADHD patients a choice of either medication, or
help with finding their Hidden Food Sensitivities. Instead, they go
straight for the drugs. They don't tell their patients anything about
the Hidden Food Sensitivity controversy. What greedy wimps. They sold
their soul to the pharmaceutical companies.

Brad_Chad


Pharms had nothing to do with it.
It's crass laziness along with putting up with idiotic mommies.

Incorrect.

It is the DOCTORS.

YOU left out idiotic DADDIES!

Says a lot about YOU!


Daddies don't bring the little kiddies into the Doctor, stupid. (rarely)


Daddies DO takes kiddies to the doctor. There is NO need to call names.


Like I said "RARELY"


Futhermore parents make decisons *together* about what medications their
children take.


Allmost never.


Now, you could say that daddies don't care if you want.


That would most certainly be a very bad daddy.


So, go fix the culture of mommy just does, Doctors are gods and daddies
watch football.


When I said crass laziness it was ABOUT DOCTORS.

What kind of mind altering meds are you on?


NONE, and this is NOT about me.


It's about your reading and comprehension capability which seem impaired.


  #73  
Old February 11th 06, 03:43 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...


"vernon" wrote in message
g.com...

"Peter Bowditch" wrote in message
...
"vernon" wrote:


"Bob Kaplow" wrote in message
...
In article , Mark Probert
writes:
"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died
over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention
deficit
disorder and hyperactivity, most of them for children."

How many people died over the same period of Tylenol (or the many
generic
equivalents) overdose? How many more suffered life threatening
complications, or are now on a wait list for an organ transplant from
Tylenol. And why aren't these same people SCREAMING to pull Tylenol off
the
market.



It takes a lot of Tylenol for a while to cause big problems. These
people
are usually in bad shape and Tylenol a "substitute" death.
No pain reliever is the safest, but next to that Tylenol is the safest
pain
reliever.


Another thing of which you are ignorant. It takes two packets and two
hours. Have you ever
watched someone having charcoal forced into their stomach to soak up
paracetamol? Have you
ever seen how easy it is to get immediate treatment in a crowded ER by
saying the words
"Panadol" and "overdose" to the triage nurse? Have you ever heard a
doctor say something
like "It was only about 24 tablets and we got to it quickly, so I am
hopeful that no real
liver damage was done"?
--


Gee 24 tablets.

Keep all medications out of the reach of children and mentally deranged.

What pain reliever is safer (not safe) and under what circumstances?

For average adult people.
Compare two tablets every four hours and allow 8 hrs sleep, for five days.


Two tablets every four hours, assuming regular strength 325mg, is a safe
dose of acetaminophen for a patient with a healthy liver. The proper dosing
interval for ibuprofen is every six hours, so two tablets (OTC strength of
200mg) every four hours would probably be an overdose, and might cause
gastrointestinal problems.



For chronic pain, still relatively normal adult average people, maximum
six months.

Which is safest. (not safe) This is a test of your knowledge for which
you have spouted.

Ibuprofen
Aspirin
Acetometaphen
Motrin (8hr span)


First of all, Ibuprofen and Motrin are the same thing, idiot. The safety is
relative, and the drugs cannot be ranked in absolute terms. For someone with
esophageal varices, acetaminophen would be far safer than ibuprofen or
aspirin. The NSAIDs would be a safer choice for someone with cirrhosis or
chronic hepatitis. All-in-all, the safest choice for acute pain is not on
your list at all; it's morphine. Even an overdose of morphine is easier to
treat successfully than overdose or adverse reactions to the meds on your
list.

--


--Rich

Recommended websites:

http://www.ratbags.com/rsoles
http://www.acahf.org.au
http://www.quackwatch.org/
http://www.skeptic.com/
http://www.csicop.org/



  #74  
Old February 11th 06, 04:20 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

Peter Bowditch wrote:
Mark Probert wrote:

JanD wrote:
02-06-06

"Mark Probert" wrote in message
...

Anecdotes are bull**** and prove nothing.

Your posting that in response to what I posted proves that you are a
heartless bitch.


These three kids didn't die coincidently with taking medication so their deaths are of no
interest to Jan. And we know she won't pray for them because, as she once said, "the child
is dead, there is no need to pray for him".


Sadly, you are correct. My son wrote a eulogy for two of them and read
them at the service his school held.




Poor Mark.

"Mark Probert" wrote in message
...
vernon wrote:
"Mark Probert" wrote in message
...
vernon wrote:
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


Why has the FDA concealed from the public 51 deaths from ADHD drugs
until
now?

51 out of around 100,000 per year of miss-prescribed and errors is
quite insignificant.
You are mistaken in your interpretation of the numbers. The NY Times
reported that this was a study of five years of records, 1999 through
2003. The number of deaths is also incorrect.

"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."

Assume that the average prescription rate is *only* 25,000,000 per year.
Since these medications are Schedule II, which means that only a one
months supply can be written at a time, approximately 2,083,333 people
per month are, on average, being prescribed these medications.

Assume that all 5 deaths happened in the same month, and you wind up
with a rate of 2.4000003840000614400098304015729e-6.

Compare that with the odds of being struck by lightening:

http://www.lightningsafety.noaa.gov/medical.htm

My younger son attends a special school for physically handicapped
students. In the past three years, two classmates have died for no
apparent reason, the last being in December 2005. One of the kids in my
neighborhood died from running the bases. His father is a DDS and was at
the school at the time. He is trained in using a defibrillator and could
not resuscitate his son.

I would classify this report and just this side of relatively
meaningless.

That's what I said.
Yeah, but not as well as I did...

The numbers really do not add up very well.

Ever wonder about how many die of no apparent reason?
Like I pointed out in the paragraph above, yes, on three occasions in the
past 2 years. One boy rode the bus with my younger son and they hung out
together outside of school. He did not wake up one morning.

One boy was the captain of my son's school's wheelchair basketball team.
No arms and two underdeveloped legs. He used one to operate the joystick
on his power chair, and the other, the longer of the two, for dribbling,
stealing and shooting. His mother thought he was sleeping on the school
bus when he came home from school.

The third is a neighborhood kid who had just finished running the bases
and died.

From the little I have seen, it is sickening. Not a conspiracy, but lack
of involvement and laws to determine.
It is very shocking for parents to sudden lose a child who is in apparent
good medical health. Sadly, even on autopsy, the actual cause of death
cannot often be determined. I know in the two cases where I know the
families well, they still do not know what happened. Both boys, having
physical disabilities, had been carefully examined and monitored over the
years.




  #75  
Old February 11th 06, 04:21 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

vernon wrote:
"Mark Probert" wrote in message
...
vernon wrote:
"Mark Probert" wrote in message
...
vernon wrote:
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


Why has the FDA concealed from the public 51 deaths from ADHD drugs
until
now?

51 out of around 100,000 per year of miss-prescribed and errors is
quite insignificant.
You are mistaken in your interpretation of the numbers. The NY Times
reported that this was a study of five years of records, 1999 through
2003. The number of deaths is also incorrect.

"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."

Assume that the average prescription rate is *only* 25,000,000 per year.
Since these medications are Schedule II, which means that only a one
months supply can be written at a time, approximately 2,083,333 people
per month are, on average, being prescribed these medications.

Assume that all 5 deaths happened in the same month, and you wind up
with a rate of 2.4000003840000614400098304015729e-6.

Compare that with the odds of being struck by lightening:

http://www.lightningsafety.noaa.gov/medical.htm

My younger son attends a special school for physically handicapped
students. In the past three years, two classmates have died for no
apparent reason, the last being in December 2005. One of the kids in my
neighborhood died from running the bases. His father is a DDS and was at
the school at the time. He is trained in using a defibrillator and could
not resuscitate his son.

I would classify this report and just this side of relatively
meaningless.

That's what I said.

Yeah, but not as well as I did...

The numbers really do not add up very well.

Ever wonder about how many die of no apparent reason?

Like I pointed out in the paragraph above, yes, on three occasions in the
past 2 years. One boy rode the bus with my younger son and they hung out
together outside of school. He did not wake up one morning.

One boy was the captain of my son's school's wheelchair basketball team.
No arms and two underdeveloped legs. He used one to operate the joystick
on his power chair, and the other, the longer of the two, for dribbling,
stealing and shooting. His mother thought he was sleeping on the school
bus when he came home from school.

The third is a neighborhood kid who had just finished running the bases
and died.

From the little I have seen, it is sickening. Not a conspiracy, but lack
of involvement and laws to determine.

It is very shocking for parents to sudden lose a child who is in apparent
good medical health. Sadly, even on autopsy, the actual cause of death
cannot often be determined. I know in the two cases where I know the
families well, they still do not know what happened. Both boys, having
physical disabilities, had been carefully examined and monitored over the
years.


It is always pretty close to possible to determine cause if there is a
desire. I know parents have a desire, but seemingly are easy to be put off
with "We just don't know"


I know the medical examiners involved, and they ALWAYS have a desire
with kids.
  #76  
Old February 11th 06, 04:26 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

JanD wrote:
"Mark Probert would like to divert from the subject again, as is his habit.
JanD wrote:
"Mark Probert blathered:

snip diversion
Bob Kaplow wrote:
snip diversion
Mark Probert writes:
"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

post restored. Jan cannot handle facts or intelligent discussion.


That would be a lie.


No, it is what you have demonstrated with just about every post you
make. The only ones that do not qualify for that are the ones where you
express your bigotry.

Jan sticks to the subject, which is NOT Tylenol.


The subject is the risk of medications used for treating AD/HD and, in
that context, the risk must be evaluated. Mentioning the risk of other
medications IS relevant.

However, I do not expect you to understand this, as you are a concrete
thinker and cannot think in a wholistic manner.

ADHD deaths ARE significant, and MORE.


All deaths are. However, you were rather dismissive of the death of a
young girl whose parents deny the existence of AIDS/HIV and denied her
evaluation and treatment. Curious that.

Ritalin 'may cause damage to brains'



We are not talking about brain damage, although you do exhibit it.
  #77  
Old February 11th 06, 04:27 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

JanD wrote:
"Bob Kaplow" wrote in message
...
In article Ss8Hf.790990$xm3.430995@attbi_s21, "JanD"
writes:
Ritalin 'may cause damage to brains'

OK, now I think I understand your problem...


It is NOT *MY* problem!


Yes, Jan, you do have a problem. Bob is right.

Sadly, you lack insight.
  #78  
Old February 11th 06, 04:29 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

vernon wrote:
"Peter Bowditch" wrote in message
...
Mark Probert wrote:

Bob Kaplow wrote:
In article , Mark Probert
writes:
"Twenty-five people died suddenly and 54 others suffered serious
unexplained heart problems while taking stimulant drugs like Ritalin
from 1999 through 2003, according to reports sent to federal drug
regulators."

Now, let's take a minute and analyze this. Twenty-five people died over
the course of 5 years. That averages to 5 deaths per year. The NYTimes
then reports that "...[a]bout 29 million prescriptions were written in
2004 for Ritalin, Adderall and similar drugs to treat attention deficit
disorder and hyperactivity, most of them for children."
How many people died over the same period of Tylenol (or the many
generic
equivalents) overdose? How many more suffered life threatening
complications, or are now on a wait list for an organ transplant from
Tylenol. And why aren't these same people SCREAMING to pull Tylenol off
the
market.
Damn, Bob, stop making sense.

APAP has one of the narrowest windows between "therapeutic" and "toxic"
of all medications. Several years ago, while I was in ICU after having
aspirated during a test, there was a girl in who was on life support
after ODing on APAP.

To people like Jan, who reject all psychiatric medicines as useless and
dangerous, it is
better to have a teenager overdose on paracetamol because they are
depressed than to give
the kid an anti-depressant drug to treat the problem. Sad that.


The sad part is the OVER prescription of mind altering drugs.


Actually, a good case can be made for UNDERprescribing, since there is
underdiagnosing.


  #79  
Old February 11th 06, 04:29 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine,alt.support.attn-deficit
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

JanD wrote:

snip everything Jan does not understand
  #80  
Old February 11th 06, 04:37 PM posted to misc.health.alternative,misc.kids.health,talk.politics.medicine
external usenet poster
 
Posts: n/a
Default 51 deaths ADHD drugs ...

JanD wrote:
"Mark Probert blathered: Jan

Is not the subject.


Like I have told you 10E100000000000000 times, whenever you post, you
are the subject.

lynn wrote:
How the heck does anyone with ADHA read such a long Cut & Paste
POSTING? IT would take 30mg of AdderallRX for me to want to read such
a long Posting. Unfortunately, I an not on Adderall.


Nothing like not sleeping from 3 to 6 AM, then sleeping until 10 AM.
The being tired and sleepy all day. Falling asleep after a light
supper.

I live on coffee but it does not stop the sleepyness during the day.

The stimulant effect of coffee is often lost on AD/HDers because the
caffeine allows your mind to settle and, then you fall asleep.

I am an adult over 60, good physical condition, 14% body fat, exercise
4 times a week, eat healthy yet I am darn tired all the time.


OBTW, 25 or 50 out of 100,000 is NOT ALARMING!


Do tell that to the parents of those 25 or 50!!!!!


Individually, it is. Collectively, it is not. I am sure that you are
incapable of seeing the difference.

Wonder what the
DWI/death rate per 100,000 motor vehicle accidents?????


Irrelevant and a diversion.


Nope. Not at all. In assessing risk, comparison is everything.

JanD wrote:
"vernon" wrote in message
g.com...
Ilena wrote in message
...
P.net!53ab2750!not-for-mail
From: "VERACARE"


Why has the FDA concealed from the public 51 deaths from ADHD drugs
until
now?

51 out of around 100,000 per year of miss-prescribed and errors is
quite
insignificant.
EVERY death is significant.

MOST significant that the FDA concealed information from the public, and
WHY!

AHRP board member, Allen Jones, will be testifying about undisclosed
conflicts of interest that undermine the integrity of FDA's advisory
committees.

The advisory panel members' undisclosed conflicts of interest
demonstrate
the FDA's complicity in putting financial interests above safety. And
it
demonstrate's FDA officials' disregard for federal conflicts of
interest
requirements. It is, perhaps, not just a coincidence that while still
under
investigation, former FDA Commissioner, Lester Crawford, has joined a
lobbying group that promotes food and drug industry interests.

Elen Liversidge will be testifying on behalf of the thousands of
famileis
whose children are casualties of psychotropic drugs--stimulants,
antidepressants, and antipsychotics--all of which are dangerous and
toxic.
It might be more effective if these drugs don't just carry a black
box, but
a scull and bones.


Contact: Vera Hassner Sharav
212-595-8974



http://abcnews.go.com/US/print?id=1595545

FDA reports 51 deaths of attention drug patientsReuters
WASHINGTON - Deaths of 51 U.S. patients who took widely prescribed
drugs to
treat attention deficit disorder prompted regulators to start watching
for
heart attacks, high blood pressure and other problems in 2004, a
report
released on Wednesday said.

The U.S. Food and Drug Administration staff did not say the drugs were
responsible for the fatalities, but they urged close monitoring for
"the
rare occurrence of pediatric sudden death during stimulant therapy."

"These reports themselves do not establish a causal relationship
between
these medications and cardiovascular adverse events," wrote Dr. Gerald
Dal
Pan, director of the FDA's Office of Drug Safety, in a separate notice
on
the agency Web site.

The information was released one day ahead of an FDA advisory panel
meeting
on how best to study potential risks from the drugs, which include
Shire
Pharmaceuticals Group Plc's Adderall and Novartis AG's Ritalin.

FDA staff scientists and experts will provide updated information at
the
meeting about serious health problems that have been reported, the
agency
said.

Use of drugs to treat attention deficit hyperactivity disorder, or
ADHD, was
controversial before the cardiac issue emerged, with many doctors and
parents arguing the medicines are overprescribed.

The FDA said it decided to seek input from an advisory panel after
reports
of sudden death, high blood pressure, heart attacks and strokes among
some
of the millions of adults and children who have taken the medicines.

Through 2003, 24 deaths were reported from 1999 through 2003 among
U.S.
patients who took Adderall for ADHD, the FDA staff report said. The
agency
excluded cases that appeared linked to intoxication from multiple
drugs or
other causes.

Another 16 deaths were reported through 2003 in U.S. patients who took
Ritalin or other ADHD drugs known as methylphenidates, the report
said.
Eleven deaths were reported among other drugs besides Adderall in the
amphetamine class, it said.

"Conclusions about the relative safety of these two stimulant
therapies
cannot be made on the basis of this analysis," the FDA staff said.

Thirty additional deaths of methylphenidate patients were recorded but
they
were either non-U.S. cases or occurred outside the review period, the
report
said.

Shire spokesman Matthew Cabrey said data have not shown any
correlation
between Adderall and the sudden deaths reported among children. He
said the
company supports the FDA's review of the matter.

Health Canada temporarily suspended Adderall sales last year after 20
reports of sudden death in people who took it. The agency allowed
Adderall
back on the market after concluding it could not prove the drug was
more
risky than other therapies.

Novartis said its own review found no increased risk of cardiovascular
problems in patients who took methylphenidates compared with the
general
population.

The FDA also has been studying if ADHD drugs may be related to
psychiatric
problems.

Republican Sen. Charles Grassley charged the FDA had taken a
"disjointed"
approach to the drugs over the past year. In a letter to the agency,
the
Iowa Republican suggested a "comprehensive" review of all ADHD
medicines.

Shares of British firm Shire fell 3.2 percent to 890.2 pence in London
trading. Novartis shares gained 5 cents to close at $54.70 on the New
York
Stock Exchange.

Copyright 2006 Reuters News Service. All rights reserved. This
material may
not be published, broadcast, rewritten, or redistributed.

Copyright C 2006 ABC News Internet Ventures

http://www.thepinksheetdaily.com/NR/FDC/images/pdly/print_masthead.gif

THE PINK SHEET
February 07, 2006
Number 004

Grassley Mows Down FDA Handling Of ADHD Drug Safety

14060207004

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is urging
FDA to
conduct a comprehensive review of side effects associated with
attention
deficit/hyperactivity disorder drugs.
In a Feb. 7 letter to Acting FDA Commissioner Andrew von Eschenbach,
Gr!
assley acknowledges that the agency is taking steps to discuss safety
concerns related to ADHD drugs, but says that the planned advisory
committee
meetings are inadequate.

On Feb. 9, FDA's Drug Safety Risk Management Advisory Committee will
discuss
cardiovascular events associated with ADHD drugs. On March 22, the
Pediatric
Advisory Committee will discuss neuropsychiatric adverse events in the
pediatric ADHD population.
[Editor's note: To 1sign up for a webcast
http://www.fdaadvisorycommittee.com/ or order a video/DVD of these
meetings, visit FDAAdvisoryCommittee.com.]

Grassley said he remains "concerned that lost between the two meetings
is a
comprehensive review of all adverse events for this entire class of
medication for all populations served."
He called FDA's actions thus far "ad hoc and disjointed."

Additionally, Grassley added, "While both psychiatric and
cardiovascular
risk signals have cropped up across this class of drugs this past
year, it
appears that FDA is just now beginning to 'discuss approaches' for
studying
these risks."

In June 2005, the committee concluded that reports of suicidality with
Johnson & Johnson's Concerta and other methylphenidate products did
not
constitute a new signal for concern.
In September, FDA issued a public health advisory on suicidal thinking
in
children and adolescents taking Lilly's Strattera for ADHD. The agency
said
it would not add a warning to other ADHD products pending an analysis
of
post-marketing adverse events from those products (2"The Pink Sheet"
DAILY,
Sept. 29, 2005
http://www.thepinksheetdaily.com/fdc...o?targetAN=140
50929002 ).

"I question why it has taken nearly an entire year for FDA to begin to
address these concerns, given the serious nature of the adverse events
associated with these drugs," Grassley said.
FDA's Psychopharmacologic Drugs Advisory Committee will convene March
23 to
review a pending ADHD drug, Cephalon's Sparlon (modafinil), which has
the
same active ingredient as Cephalon's sleep disorder therapy Provigil
(3"The
Pink Sheet" DAILY, Jan. 25, 2006
http://www.thepinksheetdaily.com/fdc...o?targetAN=140
60125006 ). One topic the committee will likely address will be how
to
distinguish Sparlon from other ADHD drugs with regard to potential
safety
issues.
-Kathleen Michael



 




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