Gregory,
Here's another development that's positive.
GM
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WASHINGTON--(BUSINESS WIRE)--March 5, 1998--
Groups Representing Almost 100,000 Women File Counter-Petition
To Secure Continued Use of Terbutaline Therapy
At the request of three national, non-profit, women's advocacy organizations, SIDELINES NATIONAL SUPPORT NETWORK, TRIPLET CONNECTION and MOTHERS OF SUPERTWINS (MOST), the High Risk Pregnancy Task Force of the COALITION FOR POSITIVE OUTCOMES IN PREGNANCY (CPOP) has filed a petition with the Food and Drug Administration (FDA) aimed at maintaining subcutaneous terbutaline pump therapy as a treatment option for managing high risk pregnancies.
Based at the Health and Medicine Counsel of Washington, CPOP is an ad hoc coalition of national and regional organizations, established in 1992 to ensure expectant families an educated, consumer voice in their pregnancy outcomes. The petitioning organizations collectively represent almost 100,000 women.
Terbutaline--FDA-approved for the treatment of asthma and from the same family of drugs as the FDA-approved but more costly ritodrine--has had a widely-accepted "off label" use as a tocolytic therapy for controlling preterm labor for nearly 20 years. On May 21, 1993, there was unanimous agreement from the Fertility & Maternal Health Advisory Committee at the FDA that terbutaline administered intravenously was safe and effective for treatment of preterm labor patients.
Delivery of terbutaline by a subcutaneous infusion pump has been a particularly successful form of tocolytic therapy because it infuses a steady amount of labor-controlling medication at much lower doses than either the intravenous or oral methods of delivery. Many physicians consider it a viable management option for high risk pregnant women who have failed oral tocolysis and who can be effectively managed at home--thus enabling them to maintain their pregnancies in the comfort and care of their families.
The use of subcutaneous terbutaline pump therapy has recently been questioned by the FDA, jeopardizing coverage by some insurers and potentially eliminating one of the few tools available to clinicians for prolonging pregnancy. The FDA seems to be basing its current opinion on a single maternal death, brought to its attention in a complaint last year by the National Women's Health Network (NWHN), an activist women's group headquartered in Washington, D.C. Among the scientific studies not referenced by the NWHN complaint is one which examined the available evidence on this death and found the death to be unrelated to terbutaline use (Perry, et. al, American Journal of Obstetrics & Gynecology, 1995). Most recently, a large retrospective clinical study on the efficacy and delivery of terbutaline, was presented by Fung Lam, M.D., at the 18th Annual Meeting of the Society of Perinatal Obstetricians in Miami on February 7, 1998. In this study, subcutaneous terbutaline pump therapy showed a 63% increase in pregnancy prolongation over oral administration.
"Aids to medicine such as this one," states Sherokee Ilse, Chairperson of CPOP's High Risk Pregnancy Task Force, "which help to prolong a pregnancy by several hours, several days, or even several weeks, can make a big difference with respect to newborn survival and neonatal outcomes. Babies lives are at stake! The FDA needs to hear from the thousands of physicians and patients--who have successfully used this form of therapy--commonly prescribed by doctors for controlling preterm labor--before it denies this critical treatment option for high risk pregnant moms."
Roger Newman, M.D., Director of Maternal-Fetal Medicine, University of South Carolina, said, "In my own practice, I am personally convinced that terbutaline therapy has saved dozens of babies, particularly among multifetal gestations. The recent FDA action against subcutaneous terbutaline therapy runs counter to its previous stand, and lacks scientific substance. Since the FDA's 1993 review, there have been no unexplained adverse events, no new labeling changes required of drug manufacturers, and no further advisory committee meetings on terbutaline that would give FDA a basis for a change in position."
"There are, however, a number of scientific studies that have been published which support the safety and efficacy of terbutaline pump therapy, which must be brought to the FDA's notice," Newman added. Approximately 260,000 U.S. women are prescribed terbutaline therapy to treat preterm labor annually, in either the hospital or home setting.
WHAT IS SUBCUTANEOUS INFUSION (PUMP) TERBUTALINE THERAPY?
When a woman has a high risk pregnancy, she often faces the challenge of preterm contractions and premature birth. Given the serious health consequences facing babies born too soon, physicians try to prolong a pregnancy at-risk for early delivery for as long as possible, to allow the baby to more fully develop. Terbutaline is prescribed by a majority of obstetricians to combat the effects of preterm labor and prolong pregnancy even though it does not have approval for this use. Physicians prescribe it as an "off label" use of the drug.
Terbutaline is a member of a class of medications called beta-adrenergic drugs. Obstetricians began prescribing from this drug class in the early 1970's when the FDA approved the use of ritodrine for the treatment of preterm labor. Terbutaline quickly supplanted ritodrine for the suppression of preterm labor for several reasons, including the fact that terbutaline allows longer periods between doses, is more effective in smaller doses with far fewer side effects, and it is lower priced than ritodrine.
Subcutaneous infusion of terbutaline therapy combines a continuous low dose basal infusion with intermittent bolus dosing to suppress uterine contractions, which frequently occur on a predictable schedule. The continuous low dose infusion and programmable boluses ensure patient compliance, avoid disrupting sleep, reduce patient stress and heighten the patient's sense of control in most cases. The continuous infusion also helps maintain the patient's blood levels in an effective therapeutic range. "Many physicians prefer this treatment and so do the patients because they can be treated in the privacy of their home. It would be a tragedy to lose any of the options available to women with difficult pregnancies. We don't want to let this happen," said Ilse. -0- *T
INTERVIEW OPPORTUNITIES: Call either contact at end of release:
Sherokee Ilse J. Stephen Jones, M.D. COALITION FOR POSITIVE Carolina Perinatal Obstetrics OUTCOMES IN PREGNANCY Greenville, SC Washington, D.C.
Maureen Boyle Harry Farb, M.D. MOTHERS OF SUPERTWINS (MOST) Director, Maternal & Fetal Brentwood, NY Medicine
North Memorial Medical Center
Minneapolis, MN
Kate Collopy, PhD (cand.), RN, CCRN, John P. Elliot, M.D. Medical Coordinator Associate Director MOTHERS OF SUPERTWINS (MOST) Maternal Fetal Medicine Brentwood, NY Good Samaritan Regional Med. Ctr.
Phoenix, AZ Candace Hurley SIDELINES NATIONAL SUPPORT NETWORK Fung Lam, M.D., FACOG Laguna Beach, CA Department of Obstetrics, Gynecology and Reproductive
Sciences, Janet Bleyl University of California, TRIPLET CONNECTION San Francisco, CA Stockton, CA
*T
CONTACT:
Judy T. Harmon 202/347-5444
or
Phipps Cohe 202/544-7499 |
