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Our Monthly Newsletter And Notes From Nancy
I hope that you find this newsletter informative and helpful. I've been trying to
browse the net to find helpful GERD information. Thanks to Leslie for helping me
with that time consuming task! Sorry this is so late, but I've been moving so I've
finally had time to sit down and to the newsletter and updates to the GERD Word.
I'm still doing research to find out what all is involved with setting up a
non-profit. the brochures will be going out soon, so hopefully we'll get some good
feedback and response from them. Thanks to Sean for getting them printed!!
Leslie is working really hard in New York and Sean is working hard in Ottawa, Canada to
Spread the Word--the GERD Word! Keep up the great work ladies.
We've added about 15 new members to the Reflux Support Email Loop in the last month and
look forward to adding even more!
Take care, and write me if you have any questions!
Nancy
Here is a link to Last month's
newsletter: September Newsletter
This Month's Newsletter Includes:
1: Cisapride and Fatal Arrythmias
2: An ABSOLUTELY FANTASTIC description and explanation of reflux by Dr. Greene(not
ER's doctor--LOL---Dr. Greene of House Calls--a great web site)
3: What is Infant Apnea?
4: Baby of The Month!
5: We are working on trying to get funding, sponsorship and banner advertising
on the GERD WORD!
6: If you think your child might not be breathing:
1: Cisapride and Fatal Arrhythmias
The New England Journal of Medicine, July 25, 1996 -- Volume 335, Number 4
Cisapride and Fatal Arrhythmia
To the Editor:
From September 1993, the month in which the marketing of cisapride (Propulsid, Janssen
Pharmaceutica, Titusville, N.J.) began, to April 1996, the Food and Drug Administration's
MedWatch reporting program (telephone number, 1-800-FDA-1088) received reports of 34
patients in whom torsade de pointes developed and 23 in whom prolonged QT intervals
developed while using this drug. Four were reported to have died, and 16 responded to
resuscitation after cardiopulmonary arrest. Arrhythmia was often preceded by syncopal
episodes. Seven of the patients were children, and one was an adolescent.
Thirty-two of the 57 patients (56 percent) were also taking medications of the imidazole
class (ketoconazole, fluconazole, itraconazole, and metronidazole) or macrolide
antibiotics (erythromycin and clarithromycin), which have been found to inhibit the
cytochrome P-450 3A4 enzyme system that affects cisapride metabolism and results in
increased serum cisapride levels. (1,2)
There were temporal associations between the onset of arrhythmia and the initiation of
cisapride, an increase in the dose, or the addition of an imidazole antifungal agent or
macrolide antibiotic. For most patients, arrhythmia stopped after the discontinuation of
cisapride or the imidazole or macrolide antibiotic (or both). In 9 of the 15 patients
tested, serum cisapride levels were higher than the mean maximal levels found in clinical
studies, although 2 patients with normal serum levels had recently undergone hemodialysis.
Torsade de pointes and prolongation of the QT interval recurred in two patients who were
rechallenged with cisapride and one rechallenged with ketoconazole. Other factors that may
have increased the risk of arrhythmia in the 57 patients included histories of coronary
disease and arrhythmia (predominantly atrial fibrillation) in 22 (39 percent), renal
insufficiency or renal failure in 14 (25 percent), electrolyte imbalance in 11 (19
percent), and long-term use of medications associated with arrhythmia or prolonged QT
intervals (such as amiodarone and phenothiazines) in 7 (12 percent).
The development of torsade de pointes and prolonged QT intervals in cisapride users
appears to be associated with conditions that affect the metabolism of the drug. These
include the concomitant use of medications that are metabolized by the cytochrome P-450
3A4 isozyme, the presence of renal insufficiency, and the administration of high doses of
cisapride. (3) Also, because there is some evidence that cisapride may be arrhythmogenic,
(4,5) users with histories of arrhythmia and cardiac disease may have an increased risk,
beyond that conferred by their disease, of prolonged QT intervals and torsade de pointes.
As stated by the manufacturer in two letters (1,2) addressed to physicians in the United
States in 1995 and in a boxed warning recently added to the cisapride product-information
label, physicians should avoid prescribing cisapride to patients who are taking
ketoconazole, fluconazole, itraconazole, miconazole, erythromycin, clarithromycin, or
troleandomycin. In addition, caution should be exercised when prescribing cisapride to
patients who are taking medications known to prolong the QT interval and to those with
renal insufficiency, a history of arrhythmia, and cardiac disease.
Diane K. Wysowski, Ph.D.
Janos Bacsanyi, M.D.
Food and Drug Administration
Rockville, MD 20857
References
1. Klausner MA, Janssen Pharmaceutica Research Foundation. Dear Doctor letters. February
3, 1995, October 14, 1995.
2. Ahmad SR, Wolfe SM. Cisapride and torsades de pointes. Lancet 1995;345:508.
3. Bran S, Murray WA, Hirsch IB, Palmer JP. Long QT syndrome during high-dose cisapride.
Arch Intern Med 1995;155:765-8.
4. Olsson S, Edwards IR. Tachycardia during cisapride treatment. BMJ 1992;305:748-9.
5. Kaumann AJ. Do human atrial 5-HT4 receptors mediate arrhythmias? Trends Pharmacol Sci
1994;15:451-5.
2: Dr. Greene's wonderful response to the question: "My daughter has
gastroesophageal reflux. Will she outgrow it? How long will it last?"
Click Here: House Calls
3: What is Infant Apnea?
INFANT APNEA; WHAT IS APNEA?
Apnea is a pause in breathing for 15 seconds or longer in a full-term baby, and 20 seconds
or longer in a premature baby. Along with this pause in breathing, the heartbeat slows
down and the baby turns bluish in color.
A premature baby's breathing pattern can be a little disorganized. She may breathe very
fast for several seconds, then have a long pause before the next breath. The reason for
this breathing pattern is probably due to the baby's immature nervous system, and is
normal in infants. It is called "periodic breathing."
WHAT CAUSES APNEA?
Normally, breathing is controlled by the brain automatically. During sleep, when the brain
is less active, breathing becomes slower and more shallow. Short pauses in breathing are
normal for babies, but with infant apnea these pauses are too long.
There are several reasons why a baby might experience apnea. Some of these are:
•infection
•seizures or other brain problems •airway
blockage
•withdrawal from drugs
•immature nervous system
Sometimes we cannot find a reason for apnea, but there are factors that seem to increase
an infant's chance of having apnea. These include:
•male sex
•premature birth •mother's
age (less than 20) •low birth weight
•one of a multiple birth (i.e., twins)
Babies are most prone to apnea if they have an upper airway infection, such as a cold. The
winter season and the time period following immunizations also seems to increase a baby's
chance of having apnea.
Some babies with apnea also have "gastroesophageal reflux" (GER). This problem
is due to the stomach valve not staying closed after feeding; the stomach acid is burped
back up the feeding tube, sometimes even to the back of the throat. When this problem is
treated, the apnea often resolves.
TREATMENT OF APNEA:
The medical team will see if the cause can be found for your baby's apnea. If the cause is
found and treated, the apnea events should stop. Even though we may not find out exactly
what causes your baby's apnea, the following treatments may be prescribed:
1.Your nurse will teach you good observation skills and what to do should your child stop
breathing at home. 2.In some cases, a home apnea monitor, with an alarm, may be prescribed
to alert you to pauses in breathing. 3.Your doctor may prescribe medication to increase
your baby's breathing rate.
Apnea can be very frightening to a family. The best thing you can do is to know what to do
when it happens.
WHAT TO EXPECT:
Apnea is usually a temporary condition which disappears with increased maturity and
improved health. Apnea of prematurity does not put your baby at risk for Sudden Infant
Death Syndrome (SIDS). If you want more information on SIDS, ask your nurse or doctor.
If a home monitor is prescribed for your baby, you can expect to use it until there have
been no important apnea alarms for two or three months. How long a monitor is used is
different for every baby and family. Doctors usually want the baby to have gotten over a
cold and the first baby shots without apnea problems before they take the baby off the
monitor.
4: We Need Reflux Child of the Month Candidates!!
We have an entire page here on the GERD Word devoted to our Reflux Child of the
Month. We need more children! If you would like to submit your child's story
and photo, please click here and send them to Nancy. Please send photos in .jpg
format.
5: We are working on trying to get funding, sponsorship and banner advertising on
the GERD WORD!
We need your help! If you know of ways to get sponsorship or grant money
please email Nancy! We are in need of financial assistance to keep this web site up
and running. We are in the process of trying to set up a non-profit organization,
called The International Organization of Reflux Parents, but it takes a lot of time and
money to do it. If you know of a way you can help, contact Nancy.
6: If you think your child might not be breathing:
IF YOU THINK YOUR BABY MIGHT NOT BE BREATHING--Infant CPR:
a. Check the baby's color by pulling the lip down and seeing if the inside of the mouth is
pink; also the baby's nailbeds should be pink. If these places are pink, just watch the
baby. Some babies have long pauses between breaths, even up to 20 seconds, but this is
considered normal if there is no color change.
b. Check for breathing by putting your cheek by the baby's mouth and see if you feel the
breath coming out. The baby's chest should be gently rising and falling with every breath.
Some babies breathe very shallowly. It is easier to see a baby breathe if he/she is lying
on his/her back.
Look, listen and feel for breathing.
c. If there is no chest movement, and the baby's color is blue, immediately begin
stimulation. Stimulate the baby by calling his/her name and rubbing his/her back or feet.
Do not shake the baby. If the baby does not start breathing, follow the next step.
2.OPEN THE BABY'S AIRWAY by tilting the baby's head back slightly. Check the mouth for any
formula, mucus, toys, etc. If you see an object in the baby's mouth, turn the head to the
side and clean out the mouth with your fingers. Open baby's airway.
3.Give two slow breaths of air, covering the infant's nose and mouth with your own mouth.
Place your mouth over the baby's nose and mouth and give 2 slow breaths.
4.Check the baby's pulse (inside of upper arm) with two fingers for about 8 seconds.
a. If pulse is present but baby is not breathing, continue mouth to mouth breathing, one
breath every 3 seconds, periodically checking to make sure the pulse is still present.
b. If pulse is not present, put the baby on a hard surface. Begin CPR. Tell someone to
call 911 for an ambulance.
5.BEGIN CPR. Position your index and middle fingers on the breastbone one fingerbreadth
below the nipple line and begin CPR using the following sequence:
5 chest compressions, 1 breath,
5 chest compressions, 1 breath.
Count to yourself:
"1, 2, 3, 4, 5, breathe"
"1, 2, 3, 4, 5, breathe"
as fast as possible. Make sure you are pressing hard enough to make the chest go down 1/2
to 1 inch.
6.CALL FOR ASSISTANCE:
If you are performing CPR and are alone, take the baby to the phone with you, call 911,
then immediately resume CPR until the life squad arrives.
7.Periodically check again for the presence of a pulse.
a. If you feel a pulse, but the baby is not breathing, stop compressions, but continue
mouth to mouth breathing, one breath every 3 seconds.
b. If you feel a pulse and the baby also begins breathing on its own, stop compressions
and mouth to mouth breathing. Stay with the baby until help arrives.
Check to see if there is a pulse.
If there is no pulse, locate proper position and start pushing breastbone in.
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