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Buprenorphine safer than methadone for neonates born to opioid addicts

Posted Jun 30 2010 10:18pm 4 Comments
Buprenorphine vs. methadone in neonates born to opiate addicts

Look mom-- no neonatal abstinence syndrome!

The article below describes a presentation at a recent meeting of ACOG, the American College of Obstetricians and Gynecologists, that compared the use of buprenorphine or  methadone for treating opioid addiction during pregnancy.  I hear from pregnant women often, who write out of frustration that their OBs have never heard of buprenorphine or Suboxone and asking what they should do to educate their physicians.  Let’s hope that studies like this one help get the word out!  If you search this blog you’ll find a number of my posts about pregnancy, opioid dependence and buprenorphine.  Some of the posts include articles about neonatal abstinence, breast feeding while taking buprenorphine, and comparisons between buprenorphine and methadone.  I also recommend, of course, the forum , where you will find many other women who have already wrestled with this issue.

Buprenorphine Favoured Over Methadone for Opiate Addiction in Pregnancy

By Fred Gebhart

SAN FRANCISCO — May 19, 2010 — A recent study in Maine among women addicted to opiates has found that buprenorphine is safer for neonates than traditional treatment with methadone.

The research was presented in an oral paper on May 18 at the American College of Obstetricians and Gynecologists’ (ACOG) 58th Annual Clinical Meeting. The paper won ACOG’s Donald F. Richardson Memorial Prize.

“It has been shown that patients on methadone are more stable in terms of their physical and mental health and are more likely to receive standard prenatal care, but methadone has clear effects on the child,” noted lead author Michael Czerkes, MD, Maine Medical Center, Portland, Maine. “Buprenorphine is an attractive alternative, but there are few data on the effects on neonatal outcomes. Since our patient population uses both agents, we decided to find out.”

The key objection to methadone from the infant’s perspective is the appearance of neonatal abstinence syndrome (NAS), a combination of symptoms that include dysfunction of the autonomic nervous system, gastrointestinal tract, and respiratory system. NAS has a number of short-term consequences, including prolonged hospital stays, prolonged monitoring, and an increased need for intravenous medications. Methadone is also inconvenient for the mother, requiring daily clinic visits, and it is subject to diversion because it is a euphoric agent.

Limited data on buprenorphine suggest that it may carry less risk for perinatal morbidity, but trials have been small and somewhat contradictory. Buprenorphine can be dispensed in 30-day packaging, which eases the burden on the mother, and is less subject to diversion because it significantly less euphoric than methadone.

Researchers at the Maine Medical Center conducted a retrospective chart review of women addicted to opioids who were using either buprenorphine or methadone and who delivered their babies at the institution between 2004 and 2008. There were 101 methadone patients and 68 buprenorphine patients available for analysis. There were no significant maternal differences between the 2 groups.

The differences between offspring of mothers in the 2 groups were dramatic, said Dr. Czerkes. The mean NAS score for buprenorphine infants was 10.69 compared with 12.5 for methadone infants (P = .0012). While the difference was statistically significant, Dr. Czerkes cautioned that it might not be clinically significant.

Other outcomes were both statistically and clinically significant. Buprenorphine infants spent a mean of 8.4 days in the hospital compared with 15.7 days for methadone infants (P < .0001) and only 48.5% of buprenorphine infants required treatment compared with 73.3% of methadone infants (P < .001).

Among buprenorphine infants who needed treatment, withdrawal symptoms appeared by day 3 or did not appear at all. Withdrawal symptoms in methadone infants appeared anywhere between days 2 and 6. “That may be a clinically significant finding,” said Dr. Czerkes. “If you don’t see withdrawal in these babies by day 3, they may not have withdrawal at all.”

Overall, he concluded, buprenorphine appears to be safer for neonates than methadone. Researchers are recruiting patients for a larger randomized controlled trial.

[Presentation title: Buprenorphine Versus Methadone Treatment for Opiate Addiction in Pregnancy: An Evaluation of Neonatal Outcomes]


Comments (4)
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A retrospective chart review is far from a scientific study and the randomized controlled study will be more clinically useful. A blinded study would be even more useful since many providers may score methadone exposed withdrawal symptoms differently due to the stigma attached to that medication.

It should be noted that all babies born opioid dependent WIIL have some withdrawal, but not all severe enough to require treatment.

Buprenorphine and methadone are both good choices for opioid dependent expectant women, but methadone has been the gold standard for decades and has been more studied than buprenorphine.

I have treated many women with methadone who have gone on to deliver healthy babies- some have required 2-3 week hospitalization and treatment for withdrawal and some have had very little withdrawal and required only short (5 day) hospitalization for observation. All babies born to moms on either medication should be observed for withdrawal symptoms for at least 5 days in the hospital since both medications have long half lives and symptoms of withdrawal can have a delayed onset.

The key to effective treatment with either medication is maintaining the patient on an effective dose- there is no one correct dose since metabolism differs from person to person. I have seen babies born to moms on as little as 20 mg of methadone have severe withdrawal and babies born to moms on 320mg have very mild withdrawal. The key to the best outcome is less about the medication choice and more about ensuring that neither mother or fetus experience withdrawal through out the entire 3 trimesters. Frequent monitoring for maternal and fetal symptoms of withdrawal and dose adjustment when necessary are paramount.

Unfortunately, buprenorphine remains unavailable to many expectant women since there are few providers in this country that are able or willing to treat pregnant, opioid dependent women with this medication.

The really impotant outcome that needs to be recognized is what is the long term results? Which maternla group maintains their recovery? What is the ultimate disposition of the child? Do the maternal dyad remain together or does the child end up in foster care due to maternal opioid dependence relapse? What is the developmental long term outcome for the child with each medication?

Who cares about NAS? It's easily treatable- a few extra days in the hospital is not nearly as detrimental to a child's long term outcome as having it's mother's recovery end up in relapse.

The medication of choice should be the one that maintains recovery the best for that particular woman and not the one that causes the least NAS.

Sharon Dembinski

Methadone Support Org

Methadone Pregnancy Info

Thank-you for the interesting and stimulating commentary on my research and presentation.  I would like to caution you as to the sub-heading "look mom no neonatal abstinence syndrome" as 50% of the babies in my study did in fact need to be treated for withdrawal, that is compared to 75% of methadone treated moms. 

 This is a retrospective chart review, I understand the limitations of this study, but it should be a springboard to more research in this area.  There is a randomized trial that is enrolling currently that will hopefully answer more questions.

 Most moms and doctors care about NAS - it may be easily treatable, but if we can avoid the treatment for a lot of mothers, it is definitely something we should strive for.  It does mean longer hospital stays and increased exposure to meds etc.  I agree that the most important part of the therapy is to maintain the mother and prevent relapse but I believe we should strive to do this with the least neonatal issues.  Methadone remains the gold standard, and is a very safe and effective treatment.  I am hopeful in the near future that buprenorphine will be more studied, have more answers and be more accessible.  Thank-you again.

 

Michael Czerkes, MD

Buprenorphine Versus Methadone Treatment for Opiate Addiction in Pregnancy: An Evaluation of Neonatal Outcomes

Lead Author 

I have to agree with Sharon when she said "The medication of choice should be the one that maintains recovery the best for that particular woman and not the one that causes the least NAS". I myself have given birth to 2 children while on methadone treatment and as I will admit, of coarse, like any mother I would have liked mine to be able to go right home as they both needed treatment for NAS (my 1st born 5 weeks and 6 days and my 2nd 8 days) the bottom line and most important thing is to maintain my abstenance, because without that, my children would not have come home at all. I do think that Suboxone is a great medication but I would hate to see a pregnant mother choose a medication because its effects after the birth are that there is little or or no extended hospital stay for the new born baby. Medication needs to be chosen based on what is best for the mother, because again, without her sobriety, the baby will not make it home in the end anyway.

Thank You,

Jessica

Primary Pregnancy Support Specialist/Addministrator at

Methadone Support.org/PregnancyInfo

I would agree with both Sharon and Jessica that the most important issue is maintaining mom's recovery. I don't think Sharon meant to say that moms don't care about NAS, but that ultimately, it's but a blip in the radar of a happy, healthy life of the baby--not something with far reaching effects that cause later problems, and not something that the entire decision on what medication to use for an expectant mom should be based upon. 

 

For example.......Let's say that a mom who has been stable on 120 mgs methadone for years becomes pregnant. Should she then be strongly urged to taper down and switch to bupe during a stressful time like pregnancy? Studies indicate that folks who need more than about 60 mgs of methadone to stabilize often do not do well on Bupe due to the ceiling effect and perhaps other factors, and the average needed dose of methadone by clinic patients is 80 to 120 mgs, with some needing much more. DO we switch all these moms over to Bupe, despite the rather high risk that it won't control symptoms, which may case relapse, or in utero withdrawals in the fetus, simply because there may be less risk of NAS later?

 

Now, if a mother using opiates becomes pregnant and is not in treatment, then the use of bupe as a first option might be a good idea, if mom is willing (and able to afford it). But for established pts who are doing well on MMT, I can't see any real reason for switching them over.  

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