Download EL E. A. T.

EL E. A. T.
Halt Ephedrine Abuse Today
Kristopher
!
R. Michal
f.,
February 8, 1999
Founder/Director
P.O. Box I I 03
g
“c::
-,
:: P.Q BP)( I;IQ3
Novi, Michigan 4S376- I 103
(248) 34 S-2598
[email protected]
/9s3199s
Barbara J. Michal
.
x..
1972-1997
Rosanna C. Porras
--
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Novi, Ml 4S376-1 103
(248) 34 S.259S
Re:
Henry Porras
Katy Porras
Docket No. 98N-0148
World Health Organization,
Proposed Ephedrine Restrictions
Directors
541 4th Street
Fillmore, CA 93015
Ladies and Gentlemen:
(805) 524-0443
My name is Barbara Michal. I am Chair of the Board of Directors of Halt Ephedrine
Abuse Today (HEAT), a non-profit national coalition I founded after ephedrine
caused the death of my 24 year old son, Kristopher, on March 14, 1997. A
newspaper story regarding Kristopher’s death is appended at Tab A. I am writing to
provide information in support of the WHO proposed restrictions on ephedrine
manufacturing and distributing.
THE FACTS ABOUT EPHEDRINE
Addiction and Abuse - Anecdotal and Scientific Evidence
Since Kristopher’s death, I have been researching this dangerous and addictive drug.
Through my work with HEAT, I have been contacted by many ephedrine users and
victims. As of February 7, 1999, of 111 contacts I have received, fifty-one percent
(51 %) report addiction. Please look at that number closely -51%. A summary of the
reports and the demographics of those who have contacted me are appended at Tab
B. These anecdotal reports show addiction to and abuse of both herbal ephedrine
products and chemical ephedrine products.
Ephedrine has been identified as a drug of abuse for years. It is listed and discussed
in the publication Drugs and Drug Abuse, 2nd Ed., Cox, Jacobs, LeBlanc, Marshman
and Fehr, published in 1987.
In July, 1995, the U.S. Food and Drug Administration published proposed rules
concerning ephedrine in over-the-counter bronchodilator products.1 In those proposed
rules, the FDA acknowledged that ephedrine carries a widespread potential for injury,
addiction, abuse and misuse.
P
VP
~1~
Food and Drug Administration
Docket No. 98N-0148
February 8, 1999
Page 2
In 1997, the National Institute of Health Sciences, in Tokyo, Japan conducted a study regarding hair
analysis to detect drugs of abuse. Ephedrine was one of the drugs listed as a drug of abuse.2
In an analysis of drug use in sports, ephedrine was identified along with amphetamine and cocaine
as stimulant drugs used and misused by athletes.3
Studies conducted in Texas have shown the addiction potential of ephedrine. Dr. Paul Wellman,
Head of the Dept. of Psychology at Texas A & M University, with his colleagues, has published two
studies showing that ephedrine has the same action as amphetamine and cocaine on dopamine in the
brain.4
Diversion into Illegal Drug Manufacture
Ephedrine is being diverted into the manufacture of two major illegal street drugs, methamphetamine
and methcathinone. Because of this growing epidemic, the Methamphetamine Control Act was
enacted in 1995 which banned single-ingredient ephedrine products and put restrictions for purchase
and possession of ephedrine in place. However, the combination products (typically the “asthma aid”
products which are combined with guaifenesin) are still being diverted. If all ephedrine products
were reclassified as prescription only, a significant source of easy ephedrine supply for illegal drug
manufacture would be eliminated.
Adverse Reactions and Injuries - Anecdotal and Scientific Evidence
I again refer you to the summary of contacts and demographic information at Tab B. These reports
of adverse reactions and injuries are alarming in scope, and they represent the tip of the iceberg.
In 1997, the FDA published an extensive report and proposed rules concerning ephedrine in dietary
supplements.5 Under these proposed rules, ephedrine in dietary supplements would be limited to 8
mg. per dose, no more than 8 mg. per 6 hours, no more than 24 mg. per 24 hours, not to be used
for more than 7 days. Additionally, it would prohibit claims for weight loss, body building, or
energy enhancement, and would prohibit combining ephedrine with any source of caffeine. These
proposed rules would also require significant warnings and contraindications in product labeling.
There have also been scientific studies and reports of injuries and deaths from ephedrine. They
identify strokeb, fatal ephedrine intoxication, coronary artery vasospasmg, dilated cardiomyopathy,
acute myocardial infarctionl”, sudden deathl 1, psychosislz 13,acute hepatitis14 and kidney damage15
lb. The medical community has been warning repeatedly about the dangers of ephedrine. It’s time
to heed the warning,
CONCLUSION
Ephedrine is a dangerous and addictive drug, in both its chemical and herbal forms. There is
growing medical, anecdotal and scientific evidence of addiction, abuse, injuries and deaths.
Additionally, ephedrine is being diverted into the manufacture of two major illegal street drugs,
methamphetamine and methcathinone. Ephedrine has no place on the over-the-counter market, even
Food and Drug Administration
Docket No. 98N-0148
February8, 1999
Page 3
in combination products. The WHO proposed restrictions do not go far enough, i.e., making
ephedrine available by prescription only no matter what kind of product contains it, but it is a step
forward in the effort to regulate this terrible and destructive drug.
I am grateful for the opportunity to share my information and opinions, and thank you for your
consideration of my comments.
Barbara J. Michal
References
1.
Federal Register, Vol. 60, No. 144:38643-47, July 27, 1995
2.
Nakahara, Y; Kikura, R. Hair analysis for drugs of abuse. XIX. Determination of
ephedrine and its homologs in rat hair and human hair. J Chromatogr B Biomed Sci Appl,
700:83-91, October 24, 1997
3.
Clarkson, P; Thompson, H. Drugs and Sport - research findings and limitations. Sports
Meal, 24(6): 366-384, December, 1997
4.
Wellman, PJ; Miller, DK; Livermore, C L; Green, TA; McMahon, LR; Nation, JR.
Effects of (-)-ephedrine on locomotion, feeding, and nucleus accumbens dopamine in rats.
J. Psychopharmacology 135:133-140, 1998
Miller, DK; McMahon, LR; Green, TA; Nation, JR; Wellman,
induces behavioral
sensitization
administration
of ephedrine
Psychopharmacology, Ms. No. 744, 1998
PJ. Repeated
in rats. J.
5.
Federal Register, Vol. 62, No. 107:30677-30724, June 4, 1997
6.
Bruno, A; Nolte, KB; Chapin, J. Stroke associated with ephedrine use. Neurology, 43:
1313-16, 1993
7.
Backer, R; Tautman, D; Lowry, S; Harvey, C; Poklis, A. Fatal ephedrine intoxication.
J. Forensic Sci, 42(l): 157-9, January, 1997
8.
Lustik, SJ; Chhibber, AK; van Vliet, M; Pomerantz, R.M. Ephedrine-induced coronary
artery vasospasm in a patient with prior cocaine use. Anesth Analg, 84:931-3, April, 1997
.
Food and Drug Administration
Docket No. 98N-0148
February 8, 1999
Page 4
9.
Gualtieri, J; Harris, C. Dilated cardiomyopathy in a heavy ephedrine abuser. J of
Toxicology, Clinical Tox, 34:581-82, 1996
10.
Cockings, JG; Brown, M. Ephedrine abuse causing acute myocardial infarction. Med J
Aust, 167: 199-200, August, 1997
11.
Theoharides, TC. Sudden death ofahealthy college stident related to ephedrine toxicity
fromama huang-containing drink. JClin Psychopharmacol, 17(5):437-39, 0ctober,1997
12.
Lake. CR; Tenglin, R; Chernow, B; Holloway, HC. Psychomotor stimulant-induced mania
in a genetically predisposed patient; a review of the literature and report of a case. J. Clin
Psychopharmacol, 3(2): 97-100, 1983
13.
Roxanas, MG; Spalding, J. Ephedrine abuse psychosis. Med J Aust, 2: 639-640,
November, 1977
14.
Nadir, A; Agrawal, S; King, PD; Marshall, JB. Acute hepatitis associated with the use of
a Chinese herbal product, ma-huang. Am J Gastroentrol, 91(7): 1436-8, July, 1996.
15.
Powell, T; Hsu, FF; Turk, J; Hruska, K. Ma-huang strikes again: ephedrine
nephrolithiasis. Am J Kidney Dis, 32(l): 153-9, July, 1998
16.
Blau, JJ. Nephrolithiasis associated with chronic ephedrine abuse. J Urol, 160(3 Pt. 1):
825, September, 1998
Mom wages war on ephedrine
What to look for
Woman blames
over-the-counter
asthma drug for
her son’s death
Ephedrine isn’t physically” ,addictive, but it can by physiologically addictive. That
means people like the !@
they get from ephedrine a_@
take more. Soon, peoPle”@
taking larger and larger doses
to get the same effect .:.
because their bodies adjust to
the amount they:re getting.
By Nicole Bondi
The Detroit News
Barb Michal never thought the
pep pills her q-year-old son picked
up in the gas station would kill him.
But they did, and Kris’ death has
Michal working to let others know
what she didn’t
—
that
ephedrine is” a
widely abused
substance that
can kill.
“I knew he
was taking it,”
said Michal, of
Novi. “He was
using it so he
wouldn’t sleep
KI+S
Michal
as much. He was
constantly pac”kinghimself with caffeine and this stuff.”
On March 14, I@ Michal popped
the small white pills for the last time.
Official cause of death: ephedrine
overdose. An autopsy showed no other drugs in his system.
More than 900 injuries and 40
deaths related to ephedrine — also
called Ma huang or herbal ecstasy —
have been reported to the Food and
Drug Administration,
spokesman
Arthur Whitmore said. Problems
., range from dizziness and tremors to
heart attacks or strokes.
“when I see it at convenience
stores, I talk to the manager about getting it off the shelves; Michal said. So
far, she has gotten three stores, including a Novi T-Eleven, to y;nk Mini
Thin, the most popular brand.
“Just from my own experience
“There’s such a potential for
abuse,” said Dr. Pamela ‘Gq;
don, a cardiologist at the
Detroit Medical. Center. i .,;.
Ephedrine can cause bksod
pressure to skyrocket or,~@.
heart to beat faster.
‘
Substance abuse counselor
Cheryl Abel surgests ~rents
look out for the-se signs of
ephedrine abuse
‘. . .
■ Hyperactivity
E Lack of appetite
9 Secretiveness or withdrawal from the family
~
■ Nausea or vomiting
9 Dizziness
■ Headaches
WI@
you Can-cji
under a<Food and Q~~ ~””
C[arence TabbJr./The Detd
,News
Barb Mich-al, with her mmddaughter, ~~ica, 4Phew her sons
mis, was t&ing ephed-tie but was una~
of the ~~e~.
seeing people buy it, it makes me
nervous,” said Rick Canzano, owner
of the Novi Y-Eleven. ‘We don’t know
what people are going to do with the
product after we sell it.”
Ephedrine, available over the
counter, is a central nervous system
stimulant used in diet pills “and food
supplements. Medically, it’s used in
decongestants and asthma medicines
Please see EPHEDRINE, Page 6C
Administration
proposal, .:
ephedrine products Would.not
be able to claim weight-loss or
body-building t%nefitiland
doses would be limited to less
than 8 milligrams e=h ?J 24
milligrams per day. MIm nin,
for instance, contains 25 milligrams of ephedrine. To-cornment on the proposal, write to
the Food and Drug Admf@
tration, Dockets Management
Branch, 12410 Parklawn Dr.,
Rockville, Md. 208:7. Mark it
for the “ephedrine docket.”
If you know someone taking
eph@rine and would !ike
more information, contact
Barb Michal at.PCl 8csx.l!03,
Novh Mich. 4@376.
,.““’
..
EPHEDRINE
Coutinited
from
Page lC
tohelp people breathe easier. But it’s
also touted by herbal experts as an
appetite suppressant and energy booster.
Widespread teen abuse of nicotine
has prompted tighter controls to keep it
out of their hands and many experts
believe ephedrine deserves the same
treatment.
The FDA is hewing public comment
through mid-December on a proposal
that w-ouh.i restrict how ephedrine is
marketed. Many states already have
banned or restricted its sale. In Michigan
possessing more than 10grams is a felony
punishable by up to two years in jail or a
$2,000
fiie.
Ten grams would be equivalent m 400 Mini Thio tablets.
After her son’s death, Michal made
sure her 6year-old daughter, Courtney,
and her friends knew about the substance and its danger.
“Iithey \veren’t taking Mini Thins,
they knew someone who was,” Michal
said. The little pills ae especially big with
teen-agers.
“It’s readily amilable. It’s at gas stations, party storesv said Cheryl Abel, a
student assistance coordinator for W~ed
Lake’smiddle schools. ‘You’llsee almost
eve~ single place has them.”
It’s often sold in six-pill packets —
which many kids fmd easy to slip into
their pockets — and is set out alongside
NO-DOZand other so-called pep pills. The pills frequently are packaged in
bright-colored pouches, with bold, colorful lettering. Mini Thin comes in bright
blue w~appings with hot pink accents.
BDI Pharmaceuticals, the company that
distributes it, recently changed the product name to Mini Two-Way Actio~ with
similar packaging.
BDI was contacted several times, but
declined to comment on its products for
this story.
Mini Thin and Mti Two-Way Action
both clearly note they’re designed for
astb
relief.
“Ephedrine is being advertised as
based on asthma medicine. The problem
is they’re marketing it as a stimulant,” said
David Katchman, a Birmingham lawyer
who works with schools and conuPunity groups, tdkirtg to kids about substance
abuse. “For someone who’s not old
enough to buy alcohol, this is easy to
obtain.”
Beyond being sold in convenience
stores, ephedrine is abundantly advertised in teen and women% magazines.
‘T.xplode with energy” reads one ad that
offem z5-mgephedrine pills in batches of
100 or 500 through the mail.
“Anything that makes claims like Mini
~in and these other products and are
available right next to the candy at the
locol party store, that’s going to spark
Clarence Tab6Jr./ The petroit News
Barb Michal blames Mini Two-Way Action and Mini Thin, both
with ephedrine, for her son Kris’ death this year at ~[.
:,;
Notthe same
as NO-DOZ
Ephedrine may be shelved next to pep pills
such as NO-DOZ and Vivarin, but they’re
not in the same class. The active ingredient in NO-DOZ is caffeine.
“So that’s no different
from drinking
two
cups of coffee,” said Dr. Pamela Gordon, a
Detroit
Medical
But caffeine
of adventure
kids
“Caffeine’s
society,”
Center cardiologist.
doesn’t
have thetsame
as ephedrine
allure
does among
1
kind of a staple of use m our
said Richard Weiss ot Maple-
grove’s Youth Treatment
ephedrine
connotation.
Center. “You say
or Mini Thin, there’s a different
The connotation
is more! ike
you’re doing a drug.”
their curiosity” Katchrnan said.
Stephanie Carl, 18, of Woodhaven,
fmt tried Mini Thin when she was 15.At
the time, she was experimenting with
every drug from cocaine to Ritalin.
Ephedrine was just one more way to get
abuzz
‘They were easy to get and they were
cheap,”Cad said.‘They were acceptable
legal and you ~idn’t have to be a certain
age to buy them.”
Carl used to take five to eight pills at
a time. The recommended dose is one
every four houm not to exceed six in q
hours. “I didn’t care how much I took or
anything,” she said.
Carl stopped using drugs when she
realized how bad her life had gotten. She
went through a drug treatment program
and has been sober for almost a year.
Yet, adults often don’t see ephedrine
as dangerous because it’sso widely available — and even sold in health food
stores.
‘men you we herbaL what do you
think? Oh it’s natural, it’s safe,” Michal
said. She asked her son to stop many
times, but never pushed it because she
.
didn’t know how harmful it could be.
“It’sjust like I told him to stop smoking too much: she xiid. ‘Yeah alcohol
can kill you if you abuse it. It’s going to
take years and years to killyou Tobacco’s
going to take years ami years to kill you.
Ephedrine will drop you like that: she
said, snapping her fmgem.
Ephedrine affects the cardlovasculx
system causing blood pressure to rise,
blood vessels to constrict and the heart
beat to quicken.
“Sometimes it felt uncomfortable
because your heart was beating really
fast: Carl said. But she would thii, “Oh
well it gives me a buz so that’s OK.”
Ephedrine has only become an issue
in the last couple of yearn.
“It’s really taken ,otT’ said Richard i
Weiss+resider$al therapist at the Maplegrove Youth Treatment Center. “Now it
almost seems like a s@ple.”Alot of kids
have had some experience with it.” :
In April, Wal-M~”began restricting
the sale of ephedrhe. Cash registeti are
programed to”limit eac~i customer ,to I
three to six pack&13+ The chain also
stopped carrying ‘the Iarge me-count
bottles.
over-the-counter
Even
Usipg
ephedrine for asthma relief — a real ~
medical purpose — could be harmful. i
“If people were using it for asthma, ~
the asthma’s probably um;ontrolled or 1
not being properly assessed by a physi- ~
cian or pharmacist,’” said Franz
Neubrecht, vice-president: of business, \
services for Phafiacy S~rvices Inc.,
part of the Michigan Pharmacists= I
& I
Association.
Neubrecht said he would like to see\
ephedrine moti strictly regtilated, but
I
not necessarily banned. .. “.~
,
~
“Ephedrine’s been used in,deconges- ~
tants for a long time. ... It’sve;y valuable .
in that regard” Neubrecht said’.“Ifit’s S@ ;
useful, it would be a shame, to totd$,,
withdraw it.”
0
NUMBER OF CONTACTS:
46
Male
65
Female
Youngest
Oldest
16 Years
47 years
Breakdown by age:
CONTACTS REPORTING
ADDICTION/DEPENDENCE:
Male
Female
February 7, 1999
111
16-20: 19 contacts
21-25: 35 contacts
26-30:31 contacts
31-35: 12 contacts
36-40: 4contacts
41-45: 5 contacts
46+:
1 contacts
Unknown age: 4 contacts
57
(51%)
54
(49 %)
22
35
CONTACTS REPORTING
DOSAGE RUN-UP:
REPORTED ADVERSE REACTIONS:
Rapid Heart Beat
Nervousness/tremors
Insomnia
Headaches
Irregular Heartbeat
Stomach Upset
Chest Pain
Shortness of Breath
Body Aches
Paranoia
Difficult Urination
Hallucinations
Blackouts
Seizures
81
73
72
49
47
46
42
41
36
31
23
18
10
6
(73%)
(66%)
(65 %)
(44 %)
(42 %)
(41%)
(38%)
(37%)
(32%)
(28%)
(21%)
(16%)
( 9%)
(5%)
USING CHEMICAL EPHEDRINE PRODUCTS:
38
Reporting Addiction:
USING HERBAL EPHEDRINE PRODUCTS:
19
Reporting Addiction:
60
51
HALT
Tabulation
EPHEDRINE
of Contacts
ABUSE
through
TODAY
February7,
1999
Pagelof
12
Page20f
12
a)
WI
m
2
Page40f
12
suicidal
Other
card. arrhyth
after stopped
feelings
emotional
migraine;
instability
panic
product
diet pills
allergy pills
Product
ma huang
ephedra
Ultra
disorder
Diet
Diet
Fuel
ma huang
Pep; Diet
ephedrine
Ultra
HCL
Slim
Citra
Mini-Thins
Ephedrine
Fuel
Starting
Amount/day
(1 tab
= 25 reg.)
Current
or Ending
White
Plus
Cross
Metabolize
Thermolift
1 pill (mg?)
2 pills
(mg?)
1 pill (mg?)
2 pills
(mg?)
9 pills
(mg?)
30 mg.
“varies”
6 pills
(mg?)
1 tab
100-150
12
2 pills
(mg?)
1 pill (mg?)
2 pills
(mg?]
6 pills
(mg?)
30 mg.
“varies”
6 pills
(mg?)
6 tabs
50 mg.
months
3 years
pills
(mg?)
mg.
Amount/day
(1 tab
= 25 reg.)
Length
of Use
1 vear
2 years
3 years
2 years
3 years
Page
5 of 12
Page60f
12
Page70f
12
Page80f
12
DATA
81
Age
12106168
Gender
Male
Marital
Status
Location
30
82
83
10102173
I
I 1 1/10/72
25
Male
Female
..
!=?A
26
09/08/79
Female
Marr!ed
I
I Married
I
~ Single
lowa
~ Geomia
I Wnnsvlvania
Single
85
19
09128172
86
26
04117165
Male
Single
33
87
88
05121162
I
\ 11107182
Female
Female
I
I Married
I
~ Married
36
90
89
18
Male
I
I Single
09120177
21
06102151 47
Female
Female
Single
Married
Connecticut
New
York
Addicted/Dependent
Rapid
Heart
Beat
81ackouts
Difficult
Urination
Irregular
Heartbeat
Seizures
Body Aches
Nervousness/Tremors
Paranoia
Chest
Pain
Insomnia
Hallucinations
Headaches
Stomach
Uoset
Shortness
of Breath
Other
Cranky
Stroke
Exacerbated
Pre-Existing
Panic
Disorder
Product
Efedrin
Metabolift
Mini-Thins
Black
Two
Wav
Diet
Fuel
Blue Ladies
Metaboiife
Up Your
Cross
Gas
Thermadrene
ephedra
Ultimate
Orancre
Starting
Amount/day
(1 tab
= 25 reg.)
Current
or Ending
5-10
tabs
1 3 doses
(mg?)
~ 2-3 tabs
4-6 tabs
9 pills
(mg?)
4-5
@
50
4 pills
(mg?)
500
mg.
+
1 pill (mg?)
1 pill (mg?)
4 pills
(mg?)
500
mg.
+
2-3
1 pill (mg?)
m9.
200
tabs
3 doses
(mg?)
15 tabs
4 tabs
9 pills
2 years
2 years
months
16@50mg.
(mg?)
pills
(mg?)
Amount/day
(1 tab
= 25 reg.)
Length
of Use
I
12 years
[
I
months
t
1 year
1
months
4 years
1 year
3 days
Page
9 of 12
.
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- —-———RECIPIENT
- “
upon dehary.
T% sendarhas requastadnotikation
upon recalj2t,
please telephom
Immad-
-.
.
—
.4----- =>.--——
‘“> PFW’’K3’”””
Nym;I
-T
E7
Nama:
Tel. No.:
)
(
FE;8#fi;99
UNITED
5T,IT6S
POSTAL
SERVICE
$1175
0000
._
—_.
_
00032~18-03
.
Dockets
Management
Branch
(HFR -30S>
Food and Drug Administration
5630 Fishers Lane, Room 1061
--- .,.-
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