Re: terbutaline for tocolysis

[Guest guest]

In a message dated 4/20/99 4:27:15 PM Eastern Daylight Time,

zlomke@... writes:

<< I appreciate your views, yet I have yet to find any information against the

use of terb for preterm labor, except a note from the FDA stating that terb

has not been studied or use for PTL approved. I can't update my practice

based on someone on a newsgroup told me...

Please, show me your references...I searched 2 search engines (Yahoo and

Infoseek) and found 1 listing from the FDA against and all the others for

terb use. >>

Your own post states the most dramatic and legitimate reason for not using

terbutaline...it is not designed for this use, AND despite its being used in

this manner for >10 years, the FDA has not approved its usage. This in itself

would be reason enough for most patients to question its use, as well as most

RM departments of hospitals! Terb is treated like any other drug which is

used without FDA approval...that is, obtaining an informed consent stating

that this med is not aprroved for use in this manner or for this diagnosis

and we fill in what that is e.e., tocolysis. There are very few drugs which

are FDA approved for use in pregnancy. See below for rationale. Our facility

is trying to gather some statiscal research for many of the drugs used in

pregnancy. It is the first hospital I have worked at that does this. Right

now, a big one is the use of cytotec for inductions of labor. We are

gathering statistical information on the use of cytotec for the purpose of

induction of labor so the consent is alittle different. It comes with an

informational brochure about FDA approval and how to make an informed choice

we provide to the patient. This is a large study which will make its

conclusions after 3 years. It is only studying intravaginal placement at

this time. The Research group is GR Research, Inc. It reminds me of the

consents used for experimental chemotherapy on our cancer patients.

We, as nurses, are not taught to distinguish drugs as FDA or non-FDA

approved and what that means. Informed " customers' " (patients) are chosing

not to use medications that are either non-FDA approved or " experimental "

without getting more information. If they are given true informed consent

and hear a med is not FDA approved for that use, they question why it is we

are using it. When you do not give a consent form, or you fail to notify them

of the lack of FDA approval you are at risk. Here's a quote from an

informational brochure given to our pregnant patients regarding FDA approval.

" The FDA has taken the position that it is unethical to test drugs in

pregnant

women by means of controlled clinical trials and follow-up. Yet the FDA

approves the use of drugs as safe for use during pregnancy, labor and birth

without requiring an initial or subsequent long-term, controlled follow-up on

a limited number of the exposed offspring in order to determine if there are

delayed adverse effects of the drug. "

Who do you think is responsible for this? Perhaps the powerful

pharmaceutical drug companies????

Here's another quote:

It is alarming, but true that many health professionals have not been taught

how to distinguish an FDA-approved use of a drug from a non-approved use.

Therefore, before you purchase or take a prescription drug you may wish to

ask your doctor, nurse or pharmacist to let you read the drug's package

insert {the information leaflet which comes in the carton from the

manufacturer). If you are hospitalized ask your doctor or nurse. If they can

not give you this information, ask the hospital pharmacist to let you read

the package insert. The package insert is written and supplied by the

manufacturer and approved by the FDA. Although written for the physician,

most consumers can understand the relevant sections (i.e., " Indications " ,

" Contraindications " , " Warnings " , " Precautions " , " Adverse Reactions, " etc. ).

Don't hesitate to question your doctor about the risks vs. the benefits of

the drug he or she may prescribe for you and about the alternatives,

including nontreatment. Your doctor is legally obligated to obtain your

informed consent to treatment. This requires your doctor to inform you of the

drug's known adverse effects, the FDA approval status of the drug, the " areas

of uncertainty " regarding the drug's delayed, long-term effects, and the

non-pharmacologic alternatives to the drug. "

Which brings me to your original post...you are correct. There are very few

articles on studies/stats involving non-use of terbutaline for tocolysis. See

above as to why I think this is true.Yet there are many articles on law suits

involving the use of terbutaline for tocolysis. Interesting.

I know that one of our perinatologists participated in a large 5 year study

at his old institution and have asked him for a reference to that study so

that I can send it to you. I apologize for the delay, he has yet to get back

to me. I will post it when I hear back. In the meantime, I would check with

your RM department. Using medications without providing a true informed

consent is something I would not be willing to participate in. Yet, before

coming to this hospital, I did not understand to what extent obtaining

informed consent should go with pregnant patients.

Jan

[Guest guest]

I do appreciate your time in investigating this for me. Since that time I

have found 2 (among others) things on the internet that I thought was

interesting. One was an article about subQ terb pump therapy--discussed

many of these issues well. http://www.tripletconnection.org/stpt.html. The

other was about a randomized clinical trial of oral terb for PTL suppression

after IV Tocolysis done by MFMU Network. Its done in 13 locations across

the US and is very well controlled. Started last June. clinical trials will

be complete Dec. of 99.

http://biostat.bsc.gwu.edu:8000/~mfmuweb/PROJECTS/terb.html

Jean