July 22, 2003

Karen M. Templeton-Somers

Center for Drug Evaluation and Research (HFD 21)

Food and Drug Administration

5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093)

Rockville, MD 20857

e-mail: SomersK@cder.fda.gov \<mailto:SomersK@cder.fda.gov\> .

# Re: SYRUP OF IPECAC

Dear Ms. Templeton-Somers,

I am writing to provide information regarding the recommendation of the
FDA Nonprescription Drug Advisory Committee (NDAC) to discontinue the
over-the-counter status of Syrup of Ipecac. This letter will make five
points:

-   **The presentations made at the NDAC meeting do not adequately
    reflect the diversity of opinion in the community of clinical
    toxicologists.**

-   **A substantial portion of the Clinical Toxicology and Poison Center
    communities believe that Syrup of Ipecac is needed for clinical use
    in the United States.**

-   **There are reasonable and medically valid uses of Syrup of Ipecac**

-   **A major proposed benefit of this decision, to reduce the abuse of
    Syrup of Ipecac, is not plausible and has not been evaluated
    adequately.**

-   **The FDA should engage Poison Centers and Clinical Toxicologists,
    the primary community recommending Syrup of Ipecac, before adopting
    the position of advocates for its elimination.**

# NDAC Presentations

I have reviewed several portions of the transcript of the NDAC meeting
and feel that they do not adequately represent the perspective of many
practicing medical toxicologists. I was particularly concerned that a
list of participants in a consensus guidelines process was shown to the
NDAC and that a first draft of the proposed Ipecac guideline was
apparently provided to the committee. As one of the panel participants,
I presume my name was among those shown to NDAC. It is important for
NDAC and FDA to understand that the presentation involved does not
reflect my assessment. Indeed, t it appears very likely that the final
guideline will specifically state that there are clinical uses for Syrup
of Ipecac. I believe the FDA should review the final guideline before
making a decision.

# Perspective of the Clinical Toxicology and Poison Center Communities

In order to obtain a more representative sample of the toxicology
community, I queried a list server maintained by the American College of
Medical Toxicology. This list server includes all members of the college
as well as large number of other health professionals involved in the
care of the poisoned patient. For example, the managing directors and
medical directors of poison centers are included on this list.

The results are striking. Appended, please find verbatim copies of the
replies. I will only comment in an overview fashion because the replies
speak for themselves. Please note that this was not a consensus process.
I simply asked what these practitioners thought about the NDAC
recommendation and these are all the replies I received. (A few replies
were not included because the individual did not reply to my request for
permission to distribute their comments.)

There are comments regarding both pro and con aspects of the issue,
although the majority support retaining the over-the-counter
availability of ipecac. My impression is that many of the replies make
the point: "We are the ones that recommend Syrup of Ipecac. Many of us
conclude that it is still needed. We do not want to see it removed." You
will also read some replies that state "We don't have data that proves
an improved outcome". That is a true statement, but I believe there are
data that indicate that it is not unreasonable to conclude that Syrup of
Ipecac can improve outcome in some cases. As some of the respondents
indicate: "Lack of evidence is not evidence of a lack of effect."

# Reasonable Uses of Syrup of Ipecac

It is important to realize that there are data supporting the use of
Ipecac. Studies have shown in volunteer subjects that Syrup of Ipecac
removes drugs and lowers blood concentration of numerous drugs. For
example, it has been shown that emesis reduces the blood level of
acetaminophen in children who have taken an accidental ingestion of
acetaminophen. Emesis occurring up to an hour after ingestions reduced
the blood levels in this population (Bond 1993). Since the treatment of
acetaminophen (e.g. acetylcysteine) is based on the serum blood level,
it is reasonable to conclude that the use of Ipecac in a population of
patients with a potentially toxic acetaminophen ingestion would lead to
fewer patients being treated with the antidote.

There are many studies that show that ipecac reduces the blood level of
various poisons. Since the blood level often correlates with toxicity,
it is logical to conclude that there is a beneficial effect from Syrup
of Ipecac. Further, when clinical toxicologists were presented with a
test case in 1998, 81.7% of them replied that they would have used Syrup
of Ipecac (this citation is included in the comments). Some of the
replies include additional citations supporting the potential clinical
usefulness of Ipecac.

Several of the correspondents provided examples of how they use Syrup of
Ipecac. While this list is not complete, it provides useful examples of
its applications:

-   Iron ingestion

-   Households in rural areas

-   Potentially toxic plant ingestions

-   Acetaminophen

-   Suspected large and recent (but still asymptomatic) ingestion of a
    life threatening agent

-   Drug whose formulation is too large to fit through a lavage tube
    (long acting calcium channel blocker)

-   Mushrooms

You can see that these indications potentially affect millions of
people. Like a fire extinguisher, few of these people may actually end
up using Ipecac; however, it needs to be available to them.

# Elimination of Syrup of Ipecac is unlikely to reduce its abuse

It is particularly striking that the advocates for removal of Ipecac use
"lack of proven efficacy" as a primary reason. This statement surely
applies to their assertion that removal of Ipecac will somehow improve
the condition of patient with anorexia nervosa, bulimia or related
conditions. It is likely true that this medication has been abused by
these populations. It has never been demonstrated, however, (to my
knowledge) that removing Ipecac as a source would improve the outcome of
this disease. These patients are highly motivated for psychiatric
reasons to either gorge and purge themselves or to deprive themselves of
food altogether. I've seen nothing (and I would appreciate receiving
this data if it exists) that demonstrates that removing this one method
of achieving their aims would prevent them from achieving them through
another route. It is extremely unlikely that the overall course of their
disease would be substantially altered simply by removing Ipecac.

The FDA should engage the primary community utilizing Syrup of Ipecac
before adopting the position of those advocating for its elimination.

I believe this remarkable response to a single email provides ample
evidence to the FDA that the NDAC did not have the opportunity to fully
consider both sides of the question. There is no doubt that the Poison
Center and Toxicology Communities are interested and willing to work
with the FDA to further evaluate this issue. Since nearly all use of
this drug arises from the recommendations of this group, it would seem
reasonable for the FDA to fully understand and evaluate their
perspective in this matter. As mentioned earlier, it is likely the final
consensus guideline will specifically provide for limited use of syrup
of ipecac. I urge the FDA to wait until the final guideline is adopted
before making its decision on the fate of syrup of ipecac.

In the end, if the question is whether the risk-benefit ratio for the
availability of Ipecac in the United States is favorable. I believe that
the truthful answer is that we just don't know. The attached
correspondence indicates that Clinical Toxicologists agree with this
evaluation. As for any drug, we can identify positive and negative
aspects. In the case of Ipecac, there are mostly theoretical and some
real advantages to having the drug available. Conversely, we don't know
the negative aspect of this drug either. It is poorly described both for
acute or chronic use. We simply do not have the means available to
perform a meaningful risk-benefit analysis for this type of product..
Since syrup of ipecac is specifically used by a substantial number of
health care providers in situations outlined above, it should remain
available for consumer use, under the direction of the Poison Control
Center or other health care professional.

Sincerely,

Richard C. Dart, MD, PhD

Director, Rocky Mountain Poison and Drug Center

Professor, University of Colorado Health Sciences Center

Conflicts of Interest: None

Bond GR, Requa RK, Krenzelok EP, et al. Influence of time until emesis
on the efficacy of decontamination using acetaminophen as a marker in a
pediatric population. Ann Emerg Med 1993;22(9):1403-1407.

**Responses from ACMT net**:

**Mary Ann Howland, PharmD** *(New York City Poison Center)*
\[MhowlandNY@aol.com\], **Lewis Goldfrank, Robert S Hoffman (Director,
NYC Poison Center)**

**Lewis Nelson, Neal Lewin, Neal Flomenbaum**

We feel strongly that there is a continued role for syrup of ipecac,
albeit it a small one. Therefore, based on a few reported instances of
abuse, we think it would be a mistake to remove syrup of ipecac from OTC
status. We have not encountered patients with problems related to syrup
of ipecac abuse in our setting in New York City. By analogy, many
patients abuse laxatives for the purposes of weight loss. Those patients
develop fluid and electrolyte problems, yet no one is suggesting that
laxatives be relegated to prescription status.

Volunteer studies demonstrate that if given while drug is still in the
stomach, syrup of ipecac decreases the amount of drug absorbed following
ingestion.1-6 In comparison to activated charcoal, syrup of ipecac is
usually less effective when studied for drugs adsorbed to activated
charcoal. However not all drugs are adsorbed to activated charcoal. In
addition patient acceptance of activated charcoal makes outpatient
administration a challenge.

We acknowledge that syrup of ipecac should not be used routinely in
overdose patients. However we do believe that syrup of ipecac remains a
beneficial therapeutic modality, especially in patients living in remote
areas or who have limited access to health care facilities.

References:

1\. Corby D, Decker W, Moran M, et al: Clinical comparison of
pharmacologic emetics in children. Pediatrics 1968;42:361-364.

2\. Curtis R, Barone J, Giacona N: Efficacy of ipecac and activated
charcoal and cathartic: Prevention of salicylate absorption in a
simulated overdose. Arch Intern Med 1984;144:48-52.

3\. McNamara R, Aaron C, Gemborys M, Davidheiser S: Efficacy of charcoal
versus ipecac in reducing serum acetaminophen in a simulated overdose.
Ann Emerg Med 1988;17:243-246.

4\. Neuvonen P, Vartiainen M, Tokola O: Comparison of activated

charcoal and ipecac syrup in prevention of drug absorption. Eur J Clin

Pharmacol 1983;24:557-562.

5\. Tenenbein M, Cohen, Sitar D: Efficacy of ipecac-induced

emesis, orogastric lavage, and activated charcoal for acute drug
overdose.

Ann Emerg Med 1987;16:838-841.

6\. Young WF, Bruin SMG: Evaluation of gastric emptying using

radionucleotides: Gastric lavage versus ipecac-induced emesis. Ann Emerg
Med

1993;22:1423-1427.

Mary Ann Howland, PharmD, DABAT, FAACT

Clinical Professor of Pharmacy

St. John's University

Consultant, NYCPCC & Bellevue Hospital ED

Lewis R. Goldfrank, MD, FACEP, FAAEM, FAACT, FACMT, FACP

Professor of Clinical Medicine, NYU

Director, Department of Emergency Medicine

Bellevue Hospital Center & NYU Medical Center

Robert S. Hoffman, MD, FACEP, FACCT, FACMT

Associate Professor, NYU

Medical Director, NYCPCC

Attending Physician, Bellevue Hospital's Emergency Department

Lewis S. Nelson, MD, FACEP, FACMT

Assistant Professor, NYU

Director, Medical Toxicology Fellowship Program

Associate Director, NYCPCC

Neal A. Lewin, MD, FACP, FACEP, FACMT

Clinical Associate Professor, NYU

Director, Didactic Education

Bellevue Hospital's Emergency Department

Consultant, NYCPCC

Neal E. Flomenbaum, MD, FACP, FACEP

Professor of Clinical Medicine,

Weill Medical College of Cornell University

Emergency Physician-in-Chief

The NY Presbyterian Hospital Emergency Department, NY Weill Cornell
Medical Center

Consultant, NYCPCC

**Shu Shum *(Medical Director, Texas Panhandle Poison Center)***

Dear Dr. Dart:

Texas Panhandle Poison Center did a survey on the use of ipecac amongst
the medical toxicologist, ABATs and CSPIs in 1998. The survey was
presented in the 1998 annual meeting, and subsequently published in Vet
Human Toxicol Vol.41 (1) 47-48 February 1999. 81.8% of medical
toxicologists responded would use syrup of ipecac in a potentially toxic
ingestion under the case described.

I agree with Dr. Goldfrank\'s group\'s comment that there are some
situation that syrup of ipecac would be valuable.

Thank you for all your work.

Shu.

**Prashant Joshi, MD (*Medical Director, Western NY Poison Center)***
\[KIDSDOC@BUFFALO.EDU\]

I do not support a move to prescription status for ipecac. Although I
recommend it only very rarely, I still believe there are limited uses
for it. I would rather see it relegated to \"behind the counter\" so it
would still be available for legitimate use.

**Bill Banner *(Medical Director Oklahoma Poison Center)***
\[WBANNER@AOL.COM\]

I too am dinosaur-like in thinking that there are rare but useful times
for ipecac. It will be unfortunate to lose this altogether. My feeling
is that a lot of pediatricians still recommend it and we will alienate
them further with ill-considered action. How we reach these decisions is
sometimes mystifying to me.

**Martin Caravati *(Medical Director, Utah Poison Center)***
\[MARTIN.CARAVATI@HSC.UTAH.EDU\]

At the Utah PCC, we are not convinced that there is absolutely no role
for ipecac in clinical toxicology. Like many other therapies in
medicine, it has some logical basis for use but the data are not
available to show definitive improvement in patient outcomes (is
avoiding an ED visit considered a benefit?). If a poison center
currently includes the use of ipecac for certain ingestions, will these
patients be referred to the ED now or just observed at home without any
decon? It will be good medicine for us to review these triage protocols
but most of the decisions will not be driven by outcome data. The
studies haven\'t been done. That\'s why some centers use ipecac to
increase the margin of safety where the toxic dose data is poor or
absent. Its removal from OTC status will probably result in a small
increase in pediatric referrals to hospital EDs for a more costly and
equally non-proven therapy: charcoal.

**Charles McKay, CT Poison Control Center** ***(Associate Medical
Director)*** \[CMCKAY@HARTHOSP.ORG\]

Certainly there are limited situations (from a nationwide perspective)
where syrup of ipecac is still recommended by SPIs and medical
toxicologists participating in initial poison center
triage/recommendations. Of course, its recommendation does not mean that
it has been demonstrated in high quality studies to improve outcome.
Then again, much of what we do would be eliminated if the same standards
were applied. Studies such as the pediatric APAP determinations with and
without home use of ipecac can be extrapolated to support its use in
situations where other treatment options are delayed or unavailable - I
remember the calls I had while in Denver from ranches in Montana or
Wyoming where access to \"formal\" healthcare is in the range of hours,
rather than minutes.

So I guess the question is whether there is more harm from its abuse by
those with eating disorders and its inappropriate use in poisonings than
there is benefit in providing parents in remote locations with something
to do that may benefit their child and make us feel better that we are
actively managing an ingestion.

**Kathleen Delaney** ***(North Texas Poison Center)***
\[KATHLEEN.DELANEY@UTSOUTHWESTERN.EDU\]

I believe that there remain some cases where ipecac is still useful.
Considered the suspected large and recent (but still asymptomatic)
ingestion of a life threatening agent whose formulation is too large to
fit through a lavage tube (long acting calcium channel blocker) or large
pill not absorbed to charcoal (lithium). These are cases where it
remains rational to try and get out as much as possible from both ends.
While ipecac may have been significantly overused in the past, it is
going to far to say that it never has a role to play in acute
decontamination.

**Robert Geller** ***(Medical Director, Georgia Poison Center)***
\[RGELLER@GEORGIAPOISONCENTER.ORG\]

It is my opinion that ipecac does have limited but definite uses. We
continue to espouse its availability in homes with young children in
Georgia, but that it should not be used without contacting the poison
center

or their physician prior to its use. Our most common use continues to be
ingestion of unknown amounts of potentially toxic mushrooms; the second
most common is ingestion of potentially toxic doses of iron.

**Wasserman, Gary, DO** \[gwasserman@cmh.edu\]

I sent response to one of our organizations when opinions were asked a
couple of months ago. I emphasized that Ipecac has a place in the early
prevention of poisoning from iron/multiVits and acetaminophen
ingestions. But this is only effective if given within about 10 minutes
of ingestion.

Why wait for patient to visit ER and then get level to see if antidote
needed if you can prevent absorption and therefore prevent the
intoxication in the first place by simply using the time-proven Ipecac?
And there is no contraindication to SOI in these ingestions because
toxicity is delayed. I\'m sure there are a few other similar toxins that
fit the profile of iron and APAP, how about poisonous mushrooms
(controversial here but reasonable to prevent later intoxication)?
Without SOI we will have many more families racing to ERs for simple
ingestions that could have been prevented by home treatment. Not to
mention the cost of these cases. Anyway this is my 2 cents worth.

**Kent Olson *(Medical Director, San Francisco Poison Division of
California Poison Center)***

Rick,

I agree with you. You put it very eloquently, and I\'d be happy to sign
on.

**Steven Marcus *(Director, New Jersey Poison
Center)***\[SMARCUS@NJPIES.ORG\]

Face the facts, we have no chance to win on this one! I wrote to the
American Academy of Pediatrics and was told that I was the only
pediatrician in the US who wrote to keep recommending ipecac in the home
when the AAP was considering eliminating this recommendation 18 months
ago! The fact that

the FDA stated that they want data-driven comments shows the
pseudo-scientists are in the driver seat. So much of what we do in
medicine can not be proven with data that it is ludicrous to look at
this one thing that critically. Everyone should view the testimony
delivered at the FDA! It is amazing when some of our brethren can so
mock the use of this substance with such abandon.

I would like everyone\'s opinion on the following cases, perhaps we can
use data from consensus to help keep ipecac as OTC. Would you use ipecac
in the following cases:

1\. a mother called and stated that she just had a fight with her 18 yo
daughter who locked herself in the bathroom and took 100 ES Tylenol
which had just been purchased. The mother was sure it had to have been
consumed because the toilet had not flushed and the bottle was just
purchased and wasn\'t opened. The family lived at least 30 minutes from
the nearest hospital.

2\. a mother called and stated that her 16 year old took 60 aspirin 325
mg. She was sure of the dose. The family was 20 minutes from the
hospital.

3\. a mother stated that her 18 month old just ate a small white
mushroom (about 1 1/2 to 2 inches in diameter growing in her lawn, she
did not know if it was in association with any decaying wood but she
could tell that it had gills and greenish-yellow spots on the top.

**William Meggs** \[MEGGSW@MAIL.ECU.EDU\]

In reply to Dr. Dart\'s note on Ipecac, I agree that there are clinical
uses for Ipecac. When used early after an ingestion in selected cases,
it can prevent toxicity. One case I recall when a tox fellow in New York
was a prisoner at Riker\'s Island who was placed in an examination room
with a bottle containing two to three hundred theophylline tablets. When
the physician came to examine him, he had consumed the entire bottle.
Ipecac was given immediately and EMS called. While being loaded on the
stretcher, he

vomited up over 200 pills as counted by the paramedics. No toxicity ever
developed from this potentially lethal dose of theophylline.

Studies of experimental ingestions with radio-labeled ingestions found
large variability in recovery of tracer in emesis after Ipecac, ranging
from 20% to 80% in some subjects. Given its potential for abuse and
morbidity and mortality with chronic use, strong arguments can be made
to rescind over-the-counter sells. Though indications are limited, to
ban the product is unwarranted.

**Bateman, Nick** \[NICK.BATEMAN@LUHT.SCOT.NHS.UK\]

\>From a European perspective surprised by you attachment to this-
haven\'t

used or recommended for 20 years!!

**Richard F. Clark *(Medical Director, San Diego Division, California
Poison System)*** \[RFCLARK@UCSD.EDU\]

There has been some interesting \"opinion\" expressed in this discussion
of ipecac. I still have trouble locating one controlled animal study,
one human case series, even one published anecdotal case report of a
situation where ipecac affected the outcome of a case of poisoning or
overdose to improve an expected bad outcome. There may be some, but none
that are well documented in the literature. Our experience in the past
15 years with a dramatic decrease in the numbers of cases for which our
poison center has recommended ipecac has shown no difference in outcome,
need for hospitalization, or recommendations for 911 or emergency
department referrals. Perhaps this is in part due to a declining number
of significant poisonings or safer medications in general but that is
not apparent from our data. In this age of \"evidence-based\" health
care, it is time we become a little more scientific in our use of
decontamination.

**Seger, Donna** ***(Medical Director, Central Tennessee Poison
Center)*** \[donna.seger@Vanderbilt.Edu\]

There are many similarities between ipecac and activated charcoal:
Neither have been shown to change outcome. the administration of these
agents is based on theory, properties of the agent, and \"beliefs\" not
data. Data from volunteers with nontoxic ingestions has been
extrapolated to poisoned patients. There is no evidence that this
extrapolation is valid. There has not been a careful analysis of
benefit:risk of administering either agent. If no benefit has been
demonstrated, and there is an increased morbidity or mortality for any
patient, the agent may be more harmful than helpful.

Regarding ipecac:

It is difficult for me to accept any arguments about the need for it in
any situation.

If the patient has taken a toxic amount of a toxin he will be sent to
the hospital whether symptomatic or asymptomatic. poison center data
demonstrates that the incidence of administration of ipecac has
decreased dramatically in the last 5 years. Morbidity and mortality has
not increased. I think all would agree that it is not a good idea to
administer this drug to patients who have a potential for a decrease in
sensorium, which is a significant number. The outcome for the patients
who have ingested agents which do not decrease the sensorium and receive
no treatment is very good. If a patient has a nontoxic ingestion and is
asymptomatic, the patient will be kept at home. Poison center data
demonstrates that these patients do well with no treatment.
Administering ipecac would increase their morbidity and mortality. It
doesn\'t make sense to say that ipecac would be useful in certain
ingestions if the patient were in a remote areas if we wouldn\'t
administer it in a nonremote area. I think these statements also apply
to activated charcoal administration. We have no data that demonstrates
a change in outcome with administration of the agent. The study
published that advocated home charcoal administered charcoal for
mushroom ingestion in over 80% of the cases. IT could be argued that
outcome was completely unaffected by charcoal in this situation. There
has been discussion that there may be a group of patients in which we
could administer home charcoal and keep the patient at home. Are these
patients with toxic or nontoxic ingestions? I\'m not sure this patient
population even exists.

There have been a number of deaths reported following the administration
of

activated charcoal. The deaths have been a result of aspiration and
inability to obtain an airway or aspiration and development of acute
lung injury. At least 2 deaths have been reported in toddlers who
aspirated charcoal which was administered for what subsequently turned
out to be a

nontoxic ingestion.

If a treatment can result in death, and the outcome would have been good
without the treatment, we need to carefully assess the treatment. The
treatment should not be more toxic than the poison.

**Woo, Olga** \[Olga_Woo@firstdatabank.com\]

During my tenured years (17) working in a PCC, I was not been a strong

advocate for the use of SI.

It had been my bias to avoid recommending SI to induce emesis for an
assessed mild or moderate intoxication. However, there have been cases
and situations where its use benefited the child and parent when the
medication or plant was returned from the stomach. The child experienced
no effect and the parent was spared worry and angst, and a potential
hospital bill. It is doubtful that any study could be performed to
provide the \"evidence-based\" studies that include objective data as
well as subjective (psychological) and economical impact showing
efficacy and benefit.

Let\'s be sure that we are aiming at the right \'tree\'. Are we being
asked to choose between the innocent pediatric patient and the
intentional behavior of an adolescent or adult by switching SI from OTC
to Rx?

Is there evidence-base information to indicate that switching SI from
OTC to Rx will lessen the abuse potential?

Look at our current state of the war against drug abuse. If there is any
evidence, it is clear from the world\'s eye that restrictive control
does not work! From the I Ching: Do not treasure goods that are hard to
get, And people will not become thieves.

We do not need more young people going to jail. I have worked in a Jail

Health Medical Service environment for 5 years and the phrase: \"Where
there

is a will, there is a way.\" is overflowing.

Banning and branding syrup of ipecac is not the answer. A partial answer

would be to keep it behind the shelf where the pharmacist can intercede
in

its sale. I hope that we can find the big picture to hang on the wall.

**Robert Hoffman** (not Bob) \[rjhoffman@pol.net\]

Good points have been made regarding this ipecac issue, but I think the
strongest have to do with evidence. I\'m not certain why the FDA
preference for data is \"pseudo-science\". At some point, toxicologists
will have to abandon the \"because I say so and I\'m the expert\"
approach and base our practices on scrutinizable data. Regarding ipecac,
data is scant, and pretty much limited to anecdotes such as that
presented by Dr. Meggs (a nice example of the benefits of ipecac in a
theo ingestion).

How about the evidence in support of changing the OTC status of ipecac?-
ipecac is the preferred emetic agent of bulemics, a preferred agent in
cases of munchausen\'s-by-proxy, and historically has been associated
with cardiomyopathy. Available evidence more strongly evidences harm or
misuse from ipecac OTC availability than it does improved outcomes from
ipecac OTC availability.

If a primary care physician decides to prescribe ipecac for storage in
their patients\' home for use after ingestions, it appears that this FDA
activity will not prevent such.

**Cyrus Rangan** \[CyrusR8248@aol.com\]

I would agree strongly with Dr. Clark\'s analysis. We could probably
argue till we\'re all blue-in-the-face about usage rates and singular
contrived scenarios\... but it seems to me that the forthcoming FDA
actions actually present us with an opportunity, not a controversy: As a
pediatrician, I can certainly say that my colleagues will soon be vocal
in their demands for an alternative home poisoning remedy. Most
toxicologists would agree that, perhaps with the exception of iron,
there aren\'t many COMMON ipecac-treated ingestions that we wouldn\'t
also treat with activated charcoal. Why NOT use this FDA/Ipecac issue as
a launching pad to influence pediatricians to get activated charcoal
into the home?

Nay-sayers will note the messiness, the unpalatability, \"..it\'s no
better than ipecac..\" etc\... but let\'s just IMAGINE astonishment of
the CSPI, when the mother on the other end of the line says, \"I\'ve got
this bottle of powdered charcoal, should I give it?\" We might make a
pharmacokinetic difference in hundreds of stay-home cases AND in send-in
cases. What about outcome measures? Who knows\... but, we\'d all love to
give AC in a boat-load more cases than in the miniscule number of
instances in which PCC\'s

currently recommend ipecac. Pretty soon, pediatricians are going to want
an answer. Let\'s take the reins and move our subspecialty into the 21st
century.

**Hedge, Matthew** \[MHEDGE@DMC.ORG\]

Yes, there are uses but there are also numerous examples for public
misuse. A case recently reported to our PCC, 3 yo drank pine-sol and mom
administered ipecac. Then mom contacted PCC. Then the child became
somnolent and started vomiting. Fortunately he had a good outcome but it
provides a clear example of the potential for public misuse of this
product.

**Prashant Joshi , MD** ***(Director, Western NY Poison Center)***
\[KIDSDOC@BUFFALO.EDU\]

I had already put in my 2 cents, so now I\'ll go for the whole nickel. I
absolutely agree with Steve Marcus. In fact, I just recommended Ipecac
for the first time in at least a year for a special case in the same
vein as the ones he enumerated.

As for the lack of data showing its efficacy, I can only quote an old
mentor

who said \"absence of evidence is not evidence of absence.\"

**Anthony S. Manoguerra** \[AMANOGUERRA@UCSD.EDU\]

If one leaves their subjective feelings aside and closely examines the
literature on the subject of ipecac, there is really only one conclusion
that can be reached. For the first ten years of my career I was a
staunch supporter of ipecac and convinced of its effectiveness. I sat
back one day, however, and asked myself exactly what was being gained
from the use of this substance for which there is no evidence of
effectiveness and which has produced serious, life-threatening, although
rare adverse effects. We stopped using ipecac 15 years ago and I cannot
recall one patient that I believe has been harmed through that decision.
I can also remember the time before then where we made hundreds of
children ill from ipecac who would have been just fine without it. I was
one of those asked to present to the FDA last month. I gave my personal
opinion but the decision of the advisory panel was also based on a
review of the literature conducted by the FDA staff that was provided to
the panel members prior to the hearing. Most of the panel members came
to their own decisions based on their review of the literature as well
as the testimony. It was clear from the discussion that if ipecac was
being presented to the panel today as a new drug for OTC use, it would
not meet the standards for safety and efficacy that currently exist. It
is amazing when some of our brethren can so accept the use of this
substance with such abandon.

**Philip D. Walson, M.D.**

We do not need more young people going to jail. I have worked in a Jail
Health Medical Service environment for 5 years and the phrase: \"Where
there is a will, there is a way.\" is overflowing.

Banning and branding syrup of ipecac is not the answer. A partial answer
would be to keep it behind the shelf where the pharmacist can intercede
in its sale.

I hope that we can find the big picture to hang on the wall.

Philip D. Walson, M.D.\
Professor of Pediatrics\
University of Cincinnati\
Director, Clinical Pharmacology Division\
    and Clinical Trials Office\
Cincinnati Children\'s Hospital Medical Center\
3333 Burnet Ave.\
Cincinnati, OH 45229-3039\
Phone 1-513-636-3232\
FAX     1-513-636-3529\
 

**Suzanne White, MD, *(Children's Hospital of Michigan Regional Poison
Center)***

Rick:

I would just like to weigh in here (pardon the pun) that I believe there
are still situations where ipecac may be useful. We all have anecdotal,
dramatic cases. I also believe that the issue of ipecac abuse by
bulimics is being exaggerated. I have not seen any hard data on the
extent of this problem. Since those with psychiatric illness and intent
to cause self-harm can potentially abuse any over-the-counter substance
or other chemical, we cannot fully protect them. And we are losing
something from our pediatric treatment armamentarium in an attempt to do
so.

(I\'m aware that my next series of comments will be obvious to you, but
am stating them here in case others have not already done so, for
possible use in your letter). There is evidence that ipecac as a safe
and efficacious method for emptying the stomach. There is not good
evidence that any form of gastric emptying improves patient outcome,
except in patients who are obtunded that present within one hour of
ingestion. However, we are basing this lack of improved outcome on a
very limited data set, in a medical condition associated with a very low
mortality, so demonstrating improved outcome is difficult.  Each case
must be assessed individually for appropriateness of gastric emptying.

Thanks, Suzanne

**Robert Geller *(Medical Director, Georgia Poison Center)***
\[RGELLER@georgiapoisoncenter.org\]

We at the Georgia Poison Center have found, as presented at a recent
meeting, that ipecac continues to be recommended in selected settings by
our clinical toxicologists and SPIs. There are, in my opinion, continued
indications for ipecac. Some of those include scenarios such as those
Steve Marcus is presenting.

The argument that decreasing ipecac use over the past decade or more has
not affected outcomes is incomplete, in my opinion, since so much else
has also evolved in the same time frame.

We must also acknowledge that much ipecac is mis-used. Whether that
makes the benefit-risk ratio in favor of continued ipecac availability
is the point of discussion. Personally, I will be disappointed to see
ipecac become unavailable, though I feel that it is inevitable at this
point.

**Steven A. Seifert, MD,** FACMT, FACEP *(Medical Director, Nebraska
Poison Center)*

Rick,

I don\'t think I responded to the ACMT net thread at the time. We no
longer routinely have ipecac in any of our protocol, but we have some
very remote areas in Nebraska and Wyoming where there are long delays to
initial medical care. In those instances, I would probably still
recommend that it be available, but used only on the advice of the
poison center.

Steve

Steven A. Seifert, MD, FACMT, FACEP

Email: sseifert@pol.net

# Tom Kurt, MD

Richard,

Sorry about the miscommunication. Keep activated charcoal in our own
household

and threw out the syrup of ipecac years ago.

Understand what you\'re saying about rural areas. Would favor chocolate
flavored charcoal being distributed by pediatricians and family
practitioners at age two on \"wellness\" followups. Feel this could be a
real marketing thing for some organization who\'s heads up on this. In
over a dozen years of out

poison center supervision I never have favored giving syrup of ipecac to
anyone less than two years old unless specifically reviewed
circumstances. Know that past advice has cautioned that such should be
done with the child over your knees with the face and airway in a
downward position to prevent aspiration

when the vomiting occurs.

And, yes, you can refer in my comments without the concurrence.

Charcoal can be just as \"fit\" for rural situations as ipecac.

Kindest regards, Richard,

Tom