contractions

Mamas on Bedrest: The Terbutaline Debate Continues

May 25th, 2011

I am a blog contributor on Lamaze International’s blog, Science and Sensibility. On April 12th, I wrote a commentary on the new guidelines and warnings issued by the FDA regarding the use of Terbutaline for the prevention of preterm labor. It created quite a stir.

In a nutshell, obstetricians were irritated (pun intended!) with my tone in that I feel that the use of Terbutaline should be severely limited if not completely banned. They challenged my authority to question their medical judgement and to demand full disclosure be given to patients regarding the off label use, the potential risks and complications as well as potential long term side effects. They all swore that most obstetricians follow ACOG guidelines for the use of Terbutaline for the prevention of preterm labor and that Terbutaline is always used responsibly and not for more then 48-72 hrs, just long enough to stabilize their patients.

However, the stories recounted by women who were on Terbutaline or who had been given Terbutaline to halt their preterm labor symptoms revealed an entirely different story. Women recounted being placed on continuous drips, daily injections and for being on the medication for weeks to months. Additionally, most of the women stated that they had not been fully informed about Terbutaline, knew nothing about it being used off label and had no idea of the potential risks and side effects. They were basically given the medication without any say whatsoever and were told it was what was needed to maintain their pregnancies.

Although that particular debate has waned, the controversy regarding the use of Terbutaline continues and underscores the pressing need for additional treatment options for high risk pregnancy and preterm labor.

Chavi Karkowsky, a second year Maternal Fetal Medicine Fellow at Albert Einstein College of Medicine/Montefiore Medical Center in New York City, wrote a blog post/case study on Medscape asking readers to indicate how they would manage a young pregnant woman with symptoms of preterm labor.

Karkowsky  provided 5 possible treatment options. Readers were also able to write in their treatment plans. The results were very interesting. Most all of the readers wanted to give the patient something-even though it wasn’t clear that the patient was experiencing preterm labor (the Fetal Fibronectin test, a test that can definitively predict preterm labor, was unavailable). Interestingly, many of the responders felt that the patient was not in preterm labor, but wanted to give her something based on her presentation, social situation and her potential for complications. Here is how the  treatment options ranked among clinician response.

Poll Results

a) She’s not in labor with that cervix. Send her home, with strict cautions. 15% (17)

b) She’s not in labor with that cervix, but she’s a little nervous-making, right? Let’s give her a dose of terb. I think she’ll eventually go home. I don’t want to give her steroids, since I think she won’t deliver within 7 days, but we’ll follow her closely as an outpatient.  9% (10)c) She’s not in labor, but terbutaline is bad, bad stuff. Didn’t you read the recent updates? Let’s give her a dose of nifedipine or indomethacin. I think I will send her home if her contractions abate, with close follow-up.  18% (21)

d) Let’s admit her- come on! She has a terrible social situation, and who knows where she’ll end up. I know her cervix is closed and long, but I want to tocolyse her properly and give her steroids. I will likely give her magnesium, given the recent data on neuroprotection.  21% (24)

e) Same as (d), but can we use a tocolytic that actually tocolyses? I’m voting for nifedipine to get her steroids on board.

31% (35)

Other Answers  6% (7)

As Karkowsky’s poll shows, there is little agreement among clinicians about the treatment of preterm labor and at times, it seems to be a bit of a crap shoot.

What I found interesting and what was advocated by a handful of practitioners was conservative observation at home, with home health nursing follow up. Novel approach? Not so much and one that is used with frequent regularity in countries with universal healthcare. Home care  with professional follow up can provide a level of surveillence similar to that of being a hospital in patient in a more comfortable environment for the patient and at a fraction of the cost of a hospital admission. But in our health care climate of “managed care”, reimbursement and litigation, this is not going to be a first line option and one that many patients would in fact prefer.

Management of high risk pregnancy and the use of Terbutaline for the prevention of preterm labor in particular will continue to be a hot bed issue. As long as we have so few treatment options for the prevention of preterm labor, until we as a culture honor pregnancy and childbearing and provide women with modified work schedules and/or paid maternity leave,  and until there is an incentive within our current health care system for less intervention and more preventive health care this debate will continue.

Mamas On Bedrest: FDA Warns Against the Use of Terbutaline To Prevent Preterm Labor!

February 18th, 2011

The below safety announcement it taken directly from the FDA website. For more news about the (discontinuing) use of terbutaline for the prevention of preterm labor, visit the FDA website.

Safety Announcement

[02-17-2011] The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.

Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.

Although it may be clinically deemed appropriate based on the healthcare professional’s judgment to administer terbutaline by injection in urgent and individual obstetrical situations in a hospital setting, the prolonged use of this drug to prevent recurrent preterm labor can result in maternal heart problems and death. Terbutaline should not be used in the outpatient or home setting.

The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information received and reviewed by the FDA. Specifically, FDA has reviewed postmarketing safety reports of terbutaline used for obstetrical indications (see Data Summary below), as well as data from the medical literature.1-6 These label changes are consistent with statements from the American College of Obstetricians and Gynecologists (ACOG).6

Additional Information for Patients

  • Be aware that serious side effects, including maternal heart problems and death, have been reported after prolonged use of terbutaline to manage preterm labor.
  • There are serious situations where a healthcare professional may decide that the short-term use of injectable terbutaline in the hospital setting may benefit a pregnant woman.
  • Oral terbutaline should not be used either to treat preterm labor or prevent recurrent preterm labor.
  • If you are taking terbutaline for another medical condition (e.g., asthma), talk to your healthcare professional if you are pregnant or become pregnant to determine whether terbutaline is still right for you.
  • FDA encourages patients to talk to their healthcare professional if they have concerns about any treatment they are receiving.
  • Report any side effects from the use of oral or injectable terbutaline to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals

  • Be aware that death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.
  • Treatment with terbutaline administered by injection or by continuous infusion pump should not be used beyond 48 to 72 hours. In particular, injectable terbutaline should not be used in the outpatient or home setting.
  • There are certain obstetrical conditions where the healthcare professional may decide that the benefit of terbutaline injection for an individual patient in a hospital setting clearly outweighs the risk.
  • Oral terbutaline is contraindicated for the treatment or prevention of preterm labor.
  • Report adverse events involving terbutaline to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.

Data Summary

In November 1997, FDA issued a Dear Colleague letter to notify healthcare professionals about concerns regarding the safety of long-term subcutaneous administration of terbutaline. The Precautions section of the labeling was revised to warn about serious adverse reactions, including cardiovascular adverse events that may occur after administration of terbutaline to women in labor.

Publications in the medical literature have reported a lack of safety and efficacy of terbutaline for the treatment of recurrent preterm labor.2-5 Despite labeling changes, FDA’s communication to the public, and professional association recommendations, prolonged use of terbutaline continues, with serious and sometimes fatal consequences.

FDA reviewed postmarketing reports of maternal death and serious cardiovascular adverse events submitted to the Adverse Event Reporting System (AERS) associated with obstetric use of terbutaline.

A search of AERS identified 16 maternal deaths that were reported since initial marketing of the drug in 1976 until 2009. Three of the 16 cases reported outpatient use of terbutaline administered by a subcutaneous pump, while nine cases reported use of oral terbutaline alone or in addition to subcutaneous or intravenous terbutaline. Of these nine cases, two reported use of oral terbutaline on an outpatient basis and seven cases involved inpatient use of oral terbutaline. The routes of administration in the remaining four cases were subcutaneous, intravenous, or unknown.

FDA identified 12 maternal cases of serious cardiovascular events associated with use of terbutaline that were reported to AERS between January 1, 1998 (after FDA issued the Dear Colleague letter) and July 2009. These events included cardiac arrhythmias, myocardial infarction, pulmonary edema, hypertension, and tachycardia. Three of the 12 cases reported use of the terbutaline administered by subcutaneous pump. Five cases involved use of oral terbutaline alone or in addition to subcutaneous terbutaline. Of these five cases, three cases involved use of oral terbutaline on an outpatient basis and two cases involved inpatient use of oral terbutaline.

In summary, based on this information, FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.

References

1. National Asthma Education and Prevention Program (NAEPP). Working Group Report on Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment—Update 2004. NIH Publication No. 05-5236. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute, 2004. Available from: http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg/astpreg_full.pdf1. Accessed November 19, 2010.

2. Wenstrom KD, Weiner CP, Merrill D, et al. A placebo-controlled randomized trial of the terbutaline pump for prevention of preterm delivery. Am J Perinatol. 1997;14:87-91.

3. Guinn DA, Goepfert AR, Owen J, et al. Terbutaline pump maintenance therapy for prevention of preterm delivery: a double-blind trial. Am J Obstet Gynecol. 1998;179:874-878.

4. Sanchez-Ramos L, Kaunitz AM, Gaudier FL, et al. Efficacy of maintenance therapy after acute tocolysis: a meta-analysis. Am J Obstet Gynecol. 1999;181:484-490.

5. Berkman ND, Thorp JM, Lohr KN, et al. Tocolytic treatment for the management of preterm labor: a review of the evidence. Am J Obstet Gynecol. 2003;188:1648-1659.

6. American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologist. No. 43. Management of preterm labor. Obstet Gynecol. 2003;101:1039-1047.

“O” or Oh no! The effect of bed rest on an intimate relationship

February 4th, 2010

During pregnancy intercourse, and more particularly orgasm, can be the most intense a woman has ever experienced. Because of the increase in blood supply during pregnancy, a woman’s perineum and sexual organs are all engorged (filled to the brim) with blood and this engorgement results in heightened sensitivity. Many women report that some of the best sex they’ve ever had was while they were pregnant. And while many may worry about the effects on the growing baby, you’ll be happy to know that an orgasm does not at all harm the baby. Even though the uterus contracts, the growing baby is so well insulated in the amniotic fluid and the strong, muscular uterus they experience mama’s orgasm as a soft ripple in the waters.

Pregnancy can also have a negative effect on a woman’s sexuality. Many women lose all interest in sexual intercourse while pregnant due to hormone  fluctuations causing a significant drop in libido. Lack of desire can also be due to the usual aches and pains of pregnancy, fatigue, nausea, the additional weight and change in body configuration leaving many women less than in the mood.

No one can predict how a woman will feel sexually while she is pregnant. Some women who enjoy robust sex lives prior to pregnancy lose all interest once they become pregnant. Likewise, more reserved women may begin initiating sexual intercourse during pregnancy. Even from pregnancy to pregnancy women report variations in their sexual libidos. They may be insatiable during one pregnancy and completely uninterested during the next.

But what about bed rest? Can women on prescribed bed rest engage in sexual intercourse? Unfortunately, most women on prescribed bed rest are advised against engaging in sexual intercourse.  Since an orgasm results in rhythmic contractions of the pelvic organs, a woman at risk of preterm labor absolutely must avoid such activity. Even without the added pregnancy intensity, anything that can cause uterine contractions and lead to preterm labor must be avoided. Some indications for bed rest may allow for some sexual activity. Gestational diabetes and hypertension (but not pre-eclampsia) for example, may require modified bed rest yet may allow for (limited?) sexual activity. When a woman is prescribed bed rest, she should ask her obstetrician or midwife specifically what her  limitations are when it comes to sexual activity

As we previously established, intimacy is a very important component of an adult relationship. It may seem like a bed rest prescription means the death of intimacy-at least for the duration of the pregnancy. But nothing could be further from the truth! Intimacy is the act of sharing between a couple; spending time enjoying one another, exchanging private thoughts and emotions, engaging in activities that they find mutually enjoyable. This can still happen between a pregnant woman and her partner.  Likewise, while intercourse may be prohibited, not all physical contact is taboo. Consider these alternatives:

  • a back and shoulder massage
  • a foot massage
  • brushing each others hair
  • deep kissing

Bed rest is not all bad for a relationship. Bed rest may actually usher in a new phase of intimacy for a couple as their efforts to find alternative ways to share intimate moments work to draw them closer.