Important: Disclaimer
Sidelines National Support Network is the largest national non-profit organization providing support, education and advocacy to women with high-risk, complicated pregnancies. We do not provide medical advice nor do we promote specific healthcare services, products, devices or drug therapies. This web site offers a forum for sharing experiences, opinions and concerns. In no way are the opinions expressed to be considered medical advice.

If you are pregnant, your physician, midwife, or other members of your healthcare team are your first and most important resource for information and guidance. Do not make any changes to the plan of care prescribed to you by your physician without consulting him or her first.

Your Voice Needs to Be Heard On a Critical Issue for Every Woman at Risk for Preterm Delivery

Sidelines strongly encourages every woman to be informed and actively involved in decisions made about the content and quality of her healthcare. This is especially important for women with high-risk pregnancies.

ONE OF THE FEW OPTIONS FOR TREATING PRETERM LABOR MAY BE TAKEN AWAY

The majority of the women we support are at high risk for preterm delivery. Unfortunately, there are few treatments available to combat preterm birth, the leading cause of infant mortality and morbidity in this country. However, those treatments which are available can be highly effective in delaying preterm birth when administered by a skilled physician in a timely manner. One of these options is subcutaneous terbutaline pump therapy (STPT).

First, Some Background

You may have read about a recent letter written by the Food and Drug Administration (FDA) to obstetricians and health care providers about STPT. In the letter, the FDA reminds readers that this therapy has not been approved for use in treating preterm labor.

The FDA was prompted to write the letter to obstetricians and health care providers on STPT because an organization known as National Women’s Health Network (NWHN) filed a petition with the FDA requesting discontinuation of this therapy. The motives of NWHN are not known but it is clear that they do not represent the interests of high-risk women. Quite the contrary. As a result of the letter, the use of terbutaline therapy is being questioned.

Most drugs used during pregnancy are prescribed “off-label” and the FDA has long acknowledged this practice. “Off-label” means that a drug, which has been approved by the FDA for one indication, can be prescribed for another indication (for example, during pregnancy). Terbutaline is one drug prescribed “off-label” for preterm labor.

Prescribing an “off-label” treatment is based on the physician’s clinical judgment and experience, and must only be done after the physician has fully informed the patient about the benefits and risks of any prescription drug.

As a support group, it is not our job to choose a patient’s treatment options. However, we are extremely concerned that STPT has been unfairly singled out for elimination by the National Women’s Health Network

We will tell you right up front that this is a complex issue. Because it is crucially important to so many high-risk mothers, we hope you will take a few moments to look at the real facts beyond the headlines and misinformation.

Facts and Information

Along with other non-profit organizations, Sidelines has represented high-risk mothers at numerous FDA hearings evaluating tocolytic therapies and medical devices. The NWHN (which is NOT a non-profit organization) also testified at each of these hearings. Each time, the NWHN never revealed whose interests they represented. In each case, NWHN urged the FDA to deny approval for the product or device under evaluation.

The only tocolytic drug approved by the FDA for treatment of preterm labor is Ritodrine. The NWHN urged the FDA to take Ritodrine off the market.

Home uterine activity monitoring (HUAM) was approved by the FDA as an aid in early detection of preterm labor. The NWHN urged the FDA to take HUAM off the market.

Use of terbutaline “off-label” was considered by an FDA panel that agreed it was
a) the most commonly used drug for treating preterm labor, b) apparently safe after more than two decades of use and c) a less expensive option to Ritodrine. The FDA urged the manufacturer of terbutaline to do the appropriate research in order to have the drug approved for use in pregnancy. The NWHN urged the FDA to discourage “off-label” use of terbutaline.

For a decade, physicians have used the drug terbutaline administered via a pump (subcutaneous terbutaline pump therapy). This offered a means for giving terbutaline in very small continuous doses in order to control preterm labor around the clock and with fewer side effects than when the drug was taken orally. Physicians only use STPT when other efforts to control preterm labor contractions fail. The NWHN filed a petition with the FDA insisting the agency take action to stop the use of STPT.

This therapy — like almost every other drug given during pregnancy — must be prescribed “off-label”. Drug manufacturers rarely test their products on pregnant women. The fact is pregnant women have diseases that need treatment. They suffer from asthma, hypertension, depression, epilepsy, and other serious health problems. Left untreated, some complications, like preterm labor, can have fatal results.

Tens of thousands of women have been safely and successfully treated with STPT. The NWHN claims there have been 2 deaths due to this treatment, but investigative research regarding these cases found NO correlation to STPT.

BEST FOR BABY Campaign

Because of these recent issues, Sidelines, along with two other support groups, The Triplet Connection, and Mothers of Supertwins (MOST), each representing tens of thousands of high-risk women, have joined together in a campaign called BEST FOR BABY. We invite you to join this campaign designed to maintain and improve comprehensive high-risk pregnancy care. The first initiative to be addressed is the support of maintaining STPT as a treatment option for high-risk mothers.

Women have helped facilitate virtually every major change in obstetrical medicine over the past two decades. Hospitals changed their policy and allowed fathers in the delivery room. Physicians began offering options for natural childbirth. And when health plans tried to impose “drive-through” deliveries, women protested so strongly that legislation was passed requiring longer hospital stays.

Your voice is heard and right now we are appealing to high-risk mothers to speak out on an issue that truly means “life or death” to tens of thousands of babies.

We are asking you to send us a letter or postcard urging your Senators and Congressmen to encourage the FDA, physicians and health care providers to not take away one of the few remaining options for treating preterm labor. The message you send is not intended to promote the use of subcutaneous terbutaline pump therapy. It is intended to ask that the decision to use or not to use this therapy be left in the hands of physicians and patients after the patient is fully informed about the benefits and risk of any drug therapy.

Your name and address will not used for any other purpose. No one will contact you unless you indicate you would like further information from Sidelines.

Sidelines will forward your postcards/letters to your area Senators and Congressmen, who evaluate the seriousness of an issue based on the volume of mail they receive. It is critical that your postcards/ letters include your signature in order to be counted. Please address your letters to Dear Senator/Congressman and mail to:

BEST FOR BABY Campaign
1611-A S. Melrose Dr., #258
Vista, CA 92083-5497

We invite you to visit the web sites of The Triplet Connection and Mothers of Supertwins for additional information. The Triplet Connection web site features articles from two prominent perinatologists on the subject of the safety and efficacy of STPT.

Allowing special interest groups to influence the quality of your medical care is a dangerous and potentially deadly development in the care of high-risk pregnancies.

Your voice needs to be heard NOW, because someday you or someone you know may be faced with the risk of delivering an extremely low birthweight, preterm baby. If this happens, we know you will want to have access to every possible option that will give your baby a fighting chance.

If you are motivated to do more than send this letter or postcard, write a letter to your physician and your health care provider addressing your concerns. We would appreciate receiving a copy of your letter.

Thank you for helping us speak out for all high-risk mothers.

Candace Hurley
Executive Director/Founder
Sidelines National Support Network

Follow this link to print two postcards and this link to print two letters.