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Q: steroids during pregnancy and their effect on the unborn child ( Answered,   3 Comments )
Question  
Subject: steroids during pregnancy and their effect on the unborn child
Category: Health
Asked by: lyn_kolb-ga
List Price: $20.00
Posted: 28 Jun 2002 07:52 PDT
Expires: 28 Jul 2002 07:52 PDT
Question ID: 34507
Are there studies being done to show a direct link between Tributalene
(a steroid given to pregant women to avoid premature contractions) and
learning disabilities in the children who were exposed to the drug
while in utero? If so, is there a way to get more information so as to
better understand what we are dealing with.  Also, I would be
interested in being part of any such studies.
Answer  
Subject: Re: steroids during pregnancy and their effect on the unborn child
Answered By: knowledge_seeker-ga on 28 Jun 2002 10:37 PDT
 
Hi lyn_kolb, 

Well, I’ve done a great deal of research on your question, and now I’m
going to go out on a limb and say, No there don’t appear to by any
studies (either past or ongoing) that address a link between the
administration of Terbutaline (the correct spelling) and learning
disabilities.

Here’s what I did find out:

Terbutaline is one of several Tocolytics; medicines that attempt to
stop labor. They are used if labor begins before term. Tocolytics can
stop labor or delay labor to give the baby's lungs time to mature. 
Terbutaline, also known as Brethine, can be taken as a pill, through
an IV (through a catheter directly into your vein), as an injection,
or through a controlled infusion pump.

Effects on the baby include: fast heart rate and high or low blood
sugar after birth.
http://www.spensershope.org/Tocolytic%20Medications.htm

Now, a key point regarding the use of Terbutaline is that it is NOT
approved by the FDA for use in pregnant women.

FDA 1997:
Terbutaline sulfate, in various dosage forms, has been approved by FDA
for the treatment of asthma. Adequate data establishing the safety and
effectiveness of the use of terbutaline as a tocolytic agent have not
been submitted to FDA. Thus, the use of terbutaline sulfate to treat
preterm labor is an unapproved or "off-label" use.
http://www.fda.gov/medwatch/safety/1997/terbut.htm

FDA 1999:
FDA reaffirms the position stated in the ‘Dear Colleague” letter that
there is no evidence of the effectiveness of prolonged treatment with
subcutaneous terbutaline to manage preterm labor and that there are
significant safety concerns associated with unmonitored, long-term
administration of the drug.
http://www.fda.gov/ohrms/dockets/dailys/102999/pdn0001.pdf

Of course, as with any drug administered during pregnancy, there are
concerns over its effect on the development of the fetus. And any
change in brain development could possibly lead to a learning
disability.

“Dr. Joseph Altman, neurobiologist, University of Indiana  pointed out
at a Washington Conference on the Precursor of Learning Disability
that the development of the human brain appears to be programmed so
that certain cells and nerve fibers must develop in synchrony, in
order to make appropriate connections within the central nervous
system. He expressed concern that drug-induced alterations of the
chemical components within the brain may interfere with the growth of
the cells and nerve fibers, causing subtle or substantial
misconnections within the developing brain.”
http://www.aimsusa.org/rothdrug.htm

To that end, there are animal studies being done on the effects of
Terbutaline on brain development:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11718842&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2590837&dopt=Abstract

The types of medical research that most people volunteer for are
clinical trials and longitudinal studies.

“A clinical trial is a study that tries to improve current treatment
or find new treatments for diseases.  They are the only reliable way
that we have to prove the effectiveness of treatments.  During a
clinical trial, information is carefully collected to assess
improvement in outcomes, and risks that may be associated with new
treatments.”
http://www.rhabdo.org/rhabdo/clintrial.htm

To be involved in a clinical trial you would volunteer yourself to be
given an experimental drug (or placebo – you would not know which) and
your outcome would be monitored. Cancer treatments, for example, are
tested this way.

A longitudinal study collects and tracks data about certain
populations over time. To volunteer for a study like this you would be
screened to meet certain criteria and then monitored over time. For
example, if a University were doing a study of the effects of prenatal
Terbutaline on children’s development, they might advertise in the
newspaper or online for volunteers with children of a certain age or
demographic.

I have been unable to find any listings of longitudinal studies or
clinical trials involving Terbutaline and its possible correlation
with learning disabilities.

In fact, I can’t find any reference at all linking the drug with
learning disabilities or with mental impairment.

Now a caveat – just because I can’t find a study, doesn’t mean it
doesn’t exist. Universities are always doing longitudinal studies but
they don’t always advertise widely. Often they want volunteers who
live nearby so they advertise locally. One approach you might take if
you are really interested is to contact the medical school or large
hospital nearest to you and find out if anyone is researching the
correlation that you mention.

Finally, one small hope here – This woman appears to have a research
interest in both Terbutaline and in child development. It’s a stretch,
but maybe an email to her would get you somewhere –

Dr. Susan C. Hupp
http://education.umn.edu/EdPsych/Faculty/Hupp.html

I hope this information and the links I provided have been useful to
you. Please let me know if you need clarification on any of the
points.

--K~


Sites searched:

Pubmed
FDA
American Medical Association

Search terms used (via Google and via the above sites):

Terbutaline “FDA approval”
Terbutaline “clinical trials”
Terbutaline “longitudinal study”
Terbutaline “learning disability”
Terbutaline “learning disabled”
Terbutaline “mental impairment”
Terbutaline “brain development”
Terbutaline “effect on infants”
Comments  
Subject: Re: steroids during pregnancy and their effect on the unborn child
From: thomy-ga on 29 Jun 2002 22:58 PDT
 
Dear lyn_kolb,

     As a Medical Doctor, I would like to share some information about
the drug Terbutaline.

     Terbutaline's main effect is bronchodilation. It is indicated to
relieve bronchospasm in Bronchial asthma, chronic bronchitis and
emphysema.  The drug is contra-indicated in cardiac patients with
associated arrhythmias, premature labour, antepartum haemorrhage and
toxaemia of pregnancy.

     Special precaution should be taken when the drug is administered
in patients with hypertension, hyperthyroidism, cardiac patients,
pregnancy and lactation.

     The side effects of the drug are pulmonary oedema (during
pregnancy), fine skeletal muscle tremor, especially in hands,
tachycardia, palpitaions, peripheral vasodilatation, hypotension,
nausea, headache, drowsiness and nervousness.

     Although learning disabilities in children does not occur with
the usage of this drug, it is better to avoid this drug during
pregnancy and lactation.

Regards,
thomy-ga.
Subject: Re: steroids during pregnancy and their effect on the unborn child
From: lyn_kolb-ga on 30 Jun 2002 17:02 PDT
 
This has been very helpful.  I am so glad that I logged on, however, I
have a question about the response from   thomy_ga that deals with
learning disabilities in children and the usage of terbutaline.  My
question is this - if the pregnant mother is ingesting this drug on a
daily basis during the entire 9 months of the baby's gestation (due to
exteme high risk as a result of 2 premature babies prior to her birth
in 1986), is this a possible risk as far as long term learning
disabilities are concerned?? My son who was born in 1982 at 26 weeks
gestation weighing 1 1b. 11 ozs. has never had learning issues,
graduated in the top 10% and is now a computer science major at
Brandeis University.  My 2nd child was born at 20 weeks two years
later and for obvious reasons died coming through the birth canal. I
then had a cervical cerclage 3 months before pregnancy, became
pregnant, was put on total bedrest and took terbutaline for 9 months. 
She was a healthy 8 pds. with no complications.  I would do it again
tomorrow inorder to have a healthy baby after what I went through. 
The doctor told me that they had not done any long term studies so I
knew that there were risks but I made the choice.  Now, with lindsay's
learning issues, all I am interested in is information that might help
us better understand what we are dealing with and I would like to help
with any studies although for now we are not saying anything to her
about this because we do not want her to have something to blame her
situation on.  We are more interested in learning more so that we can
get her help to overcome the obstacles.

Thanks again for you time and comments!!!

Lyn
Subject: Re: steroids during pregnancy and their effect on the unborn child
From: sk1-ga on 04 Aug 2002 16:01 PDT
 
Hi lyn,

I was doing research on this subject and found several links that may
be helpfuly including on that has joural articles that referece
studies. Please see below. My sister was on Terbutaline for 2/3 of her
2nd pregnancy and is currently having many difficulties with her son.
Many of these difficulties she is attributing to the use of
Terbutaline. I hope the information below is helpful.

SK

http://www.childbirthsolutions.com/articles/birth/prenatal/index.php

http://www.fda.gov/medwatch/safety/1997/terbut.htm

http://www.tripletconnection.org/drtnote.html  (You may want to note
the source of this one)

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