FDA Report Details 25 ADHD Drug Deaths

http://news.yahoo.com/s/ap/20060209/...ltBHNlYwM3MTY-

WASHINGTON - Twenty-five people died and 54 more suffered serious
cardiovascular problems after taking drugs to treat attention deficit
hyperactivity disorder between 1999 and 2003, the government says.


Children accounted for 19 of the deaths and 26 of the cases of
nonfatal cardiovascular problems, including heart attack, stroke,
hypertension, palpitations and arrhythmia, according to a Food and
Drug Administration report released Wednesday.

The FDA report also includes data on another 26 deaths between 1969
and 2003 in ADHD drug patients. Those include death by suicide,
intentional overdose, drowning, heat stroke and from underlying
disease.

The report's release came a day before an FDA panel was to discuss new
ways of examining the potential cardiovascular risks of the drugs,
which include amphetamines such as Adderall, and methylphenidates,
sold as Ritalin, Concerta, Methylin and Metadate.

The few studies that have looked at longer-term use of ADHD drugs
provide little information on those risks, the FDA said. The
cardiovascular risks include heart attack, stroke, hypertension,
palpitations and arrhythmia.

Sales of drugs to treat ADHD have increased sharply in recent years,
with use growing at a faster rate among adults than children,
according to a recent study by Medco Health Solutions, a prescription
benefit manager. Spending on ADHD drugs soared from $759 million in
2000 to $3.1 billion in 2004, according to IMS Health, a
pharmaceutical information and consulting firm.

Death and injury reports led the FDA's Canadian counterpart, Health
Canada, to yank the ADHD drug Adderall XR from the market for six
months last year.

A Canadian panel eventually concluded there was inadequate evidence of
increased harm from Adderall XR compared with other available
therapies, a conclusion the FDA also reached based on data on hand.

The FDA review released Wednesday found fewer than one adverse event —
that is, a death or serious injury — per 1 million ADHD drug
prescriptions filled, with the sole exception of the 1.79 cases per
million of nonfatal cardiovascular or cerebrovascular problems
reported in adults treated with amphetamines. Also, in some of the
cases, the children who died were later found to have had undiagnosed
heart conditions. And in three of the five cases of death in adults
receiving amphetamine treatment, the patients had pre-existing
hypertension. That suggests hypertension "may be an important risk
factor for sudden death in the adult population," the report said.

However, the report noted, the rare occurrence of sudden death in
children treated with drugs for ADHD "warrants close monitoring." One
possibility would be to add labeling to the drugs that would recommend
that doctors consider the benefits and risks of prescribing the drugs
to patients with heart problems, the report concluded.

Adderall is made by Shire Pharmaceuticals and Ritalin is made by
Novartis Pharmaceuticals Corp. Various other companies make generic
versions of Ritalin as well.

The FDA has asked its Drug Safety and Risk Management advisory
committee to discuss the feasibility of different ways of studying
whether the deaths are linked to use of the drugs, as well as specific
ways of conducting such studies.

That earned the FDA a rebuke from Sen. Chuck Grassley, R-Iowa, who
contended such work should have already begun.

In a letter sent Monday to acting FDA commissioner Dr. Andrew von
Eschenbach, Grassley said in part, "I remain concerned that 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'

Ilena Rose wrote:
http://news.yahoo.com/s/ap/20060209/...ltBHNlYwM3MTY-

WASHINGTON - Twenty-five people died and 54 more suffered serious
cardiovascular problems after taking drugs to treat attention deficit
hyperactivity disorder between 1999 and 2003, the government says.


Children accounted for 19 of the deaths and 26 of the cases of
nonfatal cardiovascular problems, including heart attack, stroke,
hypertension, palpitations and arrhythmia, according to a Food and
Drug Administration report released Wednesday.

The FDA report also includes data on another 26 deaths between 1969
and 2003 in ADHD drug patients. Those include death by suicide,
intentional overdose, drowning, heat stroke and from underlying
disease.

The report's release came a day before an FDA panel was to discuss new
ways of examining the potential cardiovascular risks of the drugs,
which include amphetamines such as Adderall, and methylphenidates,
sold as Ritalin, Concerta, Methylin and Metadate.

The few studies that have looked at longer-term use of ADHD drugs
provide little information on those risks, the FDA said. The
cardiovascular risks include heart attack, stroke, hypertension,
palpitations and arrhythmia.

Sales of drugs to treat ADHD have increased sharply in recent years,
with use growing at a faster rate among adults than children,
according to a recent study by Medco Health Solutions, a prescription
benefit manager. Spending on ADHD drugs soared from $759 million in
2000 to $3.1 billion in 2004, according to IMS Health, a
pharmaceutical information and consulting firm.

Death and injury reports led the FDA's Canadian counterpart, Health
Canada, to yank the ADHD drug Adderall XR from the market for six
months last year.

A Canadian panel eventually concluded there was inadequate evidence of
increased harm from Adderall XR compared with other available
therapies, a conclusion the FDA also reached based on data on hand.

The FDA review released Wednesday found fewer than one adverse event -
that is, a death or serious injury - per 1 million ADHD drug
prescriptions filled, with the sole exception of the 1.79 cases per
million of nonfatal cardiovascular or cerebrovascular problems
reported in adults treated with amphetamines. Also, in some of the
cases, the children who died were later found to have had undiagnosed
heart conditions. And in three of the five cases of death in adults
receiving amphetamine treatment, the patients had pre-existing
hypertension. That suggests hypertension "may be an important risk
factor for sudden death in the adult population," the report said.

However, the report noted, the rare occurrence of sudden death in
children treated with drugs for ADHD "warrants close monitoring." One
possibility would be to add labeling to the drugs that would recommend
that doctors consider the benefits and risks of prescribing the drugs
to patients with heart problems, the report concluded.

Adderall is made by Shire Pharmaceuticals and Ritalin is made by
Novartis Pharmaceuticals Corp. Various other companies make generic
versions of Ritalin as well.

The FDA has asked its Drug Safety and Risk Management advisory
committee to discuss the feasibility of different ways of studying
whether the deaths are linked to use of the drugs, as well as specific
ways of conducting such studies.

That earned the FDA a rebuke from Sen. Chuck Grassley, R-Iowa, who
contended such work should have already begun.

In a letter sent Monday to acting FDA commissioner Dr. Andrew von
Eschenbach, Grassley said in part, "I remain concerned that 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'

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies. There are several books about this.
For example, "Dr, Braly's Food Allergy and Nutrition Revolution". You
can also talk to a naturopathic doctor (Yellow Pages) or an alternative
doctor (www.acam.org) for more information.

Brad_Chad

Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.

You mean that methylphenidate and Adderall treat hidden food allergies?

"Mark Probert" wrote in message
...
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.

You mean that methylphenidate and Adderall treat hidden food allergies?

No, dummy, Canadian Bourbon, reduces all signs quickly :)

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

"Mark Probert" wrote in message
...
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.

You mean that methylphenidate and Adderall treat hidden food allergies?

No, dummy, Canadian Bourbon, reduces all signs quickly :)

There's no such thing as Canadian bourbon.
--


--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/

vernon wrote:
"Mark Probert" wrote in message
...
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.
You mean that methylphenidate and Adderall treat hidden food allergies?

No, dummy, Canadian Bourbon, reduces all signs quickly :)

That is tough therapy. Highly addictive with short term side effects.
The Kentucky brand is much smoooooooooooooooother.

"Mark Probert" wrote in message
news
vernon wrote:
"Mark Probert" wrote in message
...
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.
You mean that methylphenidate and Adderall treat hidden food allergies?

No, dummy, Canadian Bourbon, reduces all signs quickly :)

That is tough therapy. Highly addictive with short term side effects. The
Kentucky brand is much smoooooooooooooooother.

That may be true, but we have to make sure we have another (non-FDA
controlled) country to blame.

vernon wrote:
"Mark Probert" wrote in message
news
vernon wrote:
"Mark Probert" wrote in message
...
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.
You mean that methylphenidate and Adderall treat hidden food allergies?
No, dummy, Canadian Bourbon, reduces all signs quickly :)
That is tough therapy. Highly addictive with short term side effects. The
Kentucky brand is much smoooooooooooooooother.

That may be true, but we have to make sure we have another (non-FDA
controlled) country to blame.

Real conspiracy theorists know that Canada is just the 51st State and is
controlled by the FDA.

"Mark Probert" wrote in message
...
vernon wrote:
"Mark Probert" wrote in message
news
vernon wrote:
"Mark Probert" wrote in message
...
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.
You mean that methylphenidate and Adderall treat hidden food
allergies?
No, dummy, Canadian Bourbon, reduces all signs quickly :)
That is tough therapy. Highly addictive with short term side effects.
The Kentucky brand is much smoooooooooooooooother.

That may be true, but we have to make sure we have another (non-FDA
controlled) country to blame.

Real conspiracy theorists know that Canada is just the 51st State and is
controlled by the FDA.


I keep forgetting. I forgot my aluminum lined steel helmet and they are
controlling my thoughts.

Mark Probert wrote:
Brad_Chad wrote:

They probably wouldn't need to take drugs for ADHD if they had
found their Hidden Food Allergies.

You mean that methylphenidate and Adderall treat hidden food allergies?

If you bothered to read what I said carefully, you shouldn't be
confused. There are so many naturopathic and alternative doctors taking
care of ADHD by changing people's diet, that medication wouldn't be a
necessity for many people, if conventional doctors stopped pushing
drugs.

Brad_Chad