I just found some info about Buprenorphine on Atwatchdog.org, I just thought I would post, in case any other expectant mothers may be reading this post. I had a really hard time finding any info, so I thought this might be useful.
Posted: Fri Jul 09, 2004 8:58 pm Post subject:
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Eur Addict Res. 1998;4 Suppl 1:32-6.
Buprenorphine maintenance in pregnant opiate addicts.
Fischer G, Etzersdorfer P, Eder H, Jagsch R, Langer M, Weninger M.
Department of General Psychiatry, University Hospital of Psychiatry, Vienna, Austria.
[email protected]
Opioid maintenance agents such as methadone and slow-release morphine have provided beneficial effects in pregnant opioid-dependent women in both themselves and their child. However, one of the major drawbacks involved with these agents is that they cause an increase in the severity of neonatal abstinence syndrome (NAS) when compared to mothers using heroin. Consequently, a trial was performed to investigate the effects of buprenorphine use during pregnancy. A total of nine pregnant opioid-dependent women were transferred from either a mean daily dose of 39.7 mg methadone or 400 mg slow-release morphine to a mean daily dose of 8.1 mg buprenorphine. The buprenorphine-maintained patients were integrated into an already established outpatient maintenance treatment programme covering all aspects of prenatal and perinatal care. Results demonstrated that buprenorphine administration in opioid-dependent pregnant patients is efficacious and well tolerated. Babies born to buprenorphine-maintained patients had birthweight and Apgar scores within the normal range (2,500-4,500 g and 9-10, respectively) and no evidence of opioid-related NAS was observed. The results from this preliminary study indicate the potential for buprenorphine maintenance therapy in pregnant addicts, although further research is required to confirm this hypothesis.
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Addiction. 2000 Feb;95(2):239-44.
Treatment of opioid-dependent pregnant women with buprenorphine.
Fischer G, Johnson RE, Eder H, Jagsch R, Peternell A, Weninger M, Langer M, Aschauer HN.
Department of General Psychiatry, University Hospital of Vienna, Austria.
[email protected]
AIMS: To assess the maternal and fetal acceptability of buprenorphine and neonatal abstinence syndrome (NAS) in children born to buprenorphine-maintained mothers. DESIGN AND SETTING: Open-label, flexible dosing, inpatient induction with outpatient maintenance, conducted at the University of Vienna within the existing pregnancy and drug addiction program. PARTICIPANTS: Fifteen opioid-dependent pregnant women. INTERVENTION: Sublingual buprenorphine tablets (1-10 mg/day). MEASUREMENTS: Mothers: withdrawal symptoms (Wang Scale), nicotine dependence (Fagerstrom Scale: FTQ) and urinalysis. Neonates: birth outcome and NAS (Finnegan Scale). FINDINGS: All subjects were opioid-, nicotine- and cannabis-dependent. Buprenorphine was well tolerated during induction (Wang Score < or = 4) and illicit opioid use was negligible (91% opioid-negative). All maternal, fetal and neonatal safety laboratory measures were within normal limits or not of clinical significance. Mean birth outcome measures including gestational age at delivery (39.6 +/- 1.5 weeks), Apgar scores (1 min = 8.9; 5 min = 9.9; and 10 min = 10), birth weight (3049 +/- 346 g), length (49.8 +/- 1.9 cm) and head circumference (34.1 +/- 1.8 cm) were within normal limits. The NAS was absent, mild (without treatment) and moderate (with treatment) in eight, four and three neonates, respectively. The mean duration of NAS was 1.1 days. CONCLUSIONS: Buprenorphine appears to be well accepted by mother and fetus, and associated with a low incidence of NAS. Further investigation of buprenorphine as a maintenance agent for opioid-dependent pregnant women is needed.
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Addiction. 2003 Jan;98(1):103-10.
Neonatal outcome following buprenorphine maintenance during conception and throughout pregnancy.
Schindler SD, Eder H, Ortner R, Rohrmeister K, Langer M, Fischer G.
Department of General Psychiatry, University Hospital of Vienna, Vienna, Austria.
AIMS: To assess the effects of maternal buprenorphine treatment at conception and during pregnancy on neonates in terms of birth outcomes and neonatal abstinence syndrome (NAS). DESIGN AND SETTING: Prospective, open-label, out-patient maintenance, case report study, conducted at the drug addiction out-patient clinic at the University Hospital Vienna. PARTICIPANTS: Two buprenorphine-maintained pregnant women who had conceived during buprenorphine treatment. Both patients had previously given birth to healthy neonates following induction on to buprenorphine maintenance therapy in the second trimester. MEASUREMENTS: Mothers: urinalysis. Neonates: gestational age at delivery, Apgar scores, birth weight, length and NAS (Finnegan Scale). FINDINGS: Urinalyses were negative for both women for 25 and 38 months, respectively, during the pregnancy period. There were no complications during the course of the pregnancy. The newborns delivered by both women were healthy, birth outcomes were within normal ranges and there were no NAS symptoms requiring treatment. CONCLUSIONS: To our knowledge this is the first report detailing the pregnancies of women treated with buprenorphine at the time of conception and investigated in a prospective study. The NAS noted in neonates born to buprenorphine-maintained mothers appears to be less severe than the NAS observed in neonates born to methadone-maintained mothers. These preliminary data indicate that, in our patient cohort, buprenorphine maintenance at the time of conception and during pregnancy did not seem to affect birth outcome measurements such as pregnancy complications, week of delivery, birth weight, length, umbilical pH or neurodevelopmental progress. Future prospective studies with larger study populations are warranted.
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Addiction. 2003 Nov;98(11):1599-604.
Buprenorphine withdrawal syndrome in newborns: a report of 13 cases.
Kayemba-Kay's S, Laclyde JP.
Neonatal Intensive Care Unit, University Teaching Hospital, Poitiers, France.
[email protected]
AIMS: To assess neonatal abstinence syndrome (NAS) and neurodevelopmental outcome in infants born to addicted mothers under buprenorphine substitution therapy. SETTING: District general hospital, Angouleme, France. METHODS: Retrospective case records study of infants admitted to the neonatal intensive care unit (NICU) and/or special care baby unit (SCBU) from January 1994 to December 2000 for surveillance and/or treatment of buprenorphine NAS. RESULTS: Thirteen infants were born to addicted mothers under buprenorphine maintenance therapy during the study period. Eight were male and five were female; mean birth term and weight were 39 weeks gestation and 3000 g, respectively. Apgar scores were within normal limits; four infants were small for gestational age, none was dysmorphologic and none was extracted for fetal distress. NAS occurred in 11 cases (85%) and required treatment in 10 cases. Morphine chlorhydrate 0.5 mg/kg/day was administered in divided doses to seven children and gave better results than paregoric alone or in combination with diazepam. Upon follow-up, seven children presented transient lower limbs hypertonia, jerky movements and jitteriness that lasted 3-9 months. The overall milestones acquisitions were within normal limits. CONCLUSION: Buprenorphine substitution seems to be safe during pregnancy, and has had no teratogenic effects reported to date. It induces NAS of variable intensity that is less prolonged in comparison to methadone; the neurodevelopmental outcome of exposed children is normal in the majority of cases, although some presented with transient motor abnormalities that resolved completely in 85% of those recruited to our study.
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Psychiatr Prax. 2001 Sep;28(6):267-9.
[Buprenorphine in pregnancy]
[Article in German]
Eder H, Rupp I, Peternell A, Fischer G.
Drogenambulanz, Klinische Abteilung fur Allgemeine Psychiatrie, Universitatsklinik fur Psychiatrie, AKH Wien, Germany.
[email protected]
The treatment of opioid dependence during pregnancy is a major challenge for doctors, social workers and gynaecologists. Continuous drug abuse during pregnancy can lead to a variety of complications in the mother, fetus and neonate. lt is recommended practice to maintain pregnant opioid-dependent women with synthetic opioids and according to international guidelines, methadone is the recommended substance so far. However, a neonatal abstinence syndrome (NAS) of varying severity is observed in 60 - 80 % of the neonates with even a longer course of duration in comparison to the NAS after heroin consumption during pregnancy. NAS is characterised by tremor, irritability, hypertonicity, vomiting, sneezing, fever, poor suckling, and sometimes convulsions. Recent studies have investigated the safety and efficacy of other synthetic opioids like sublingual buprenorphine for the treatment of pregnant patients. We present a 22 year old opioid-dependent woman, who has been maintained continuously on buprenorphine for 3 years. During the treatment episode she delivered two healthy newborns and both did not show any symptoms of NAS. The maintenance therapy with buprenorphine proved safety and efficacy during pregnancy, the mother was free of continuous heroin abuse, verified through supervised urine-toxicology. The quantitative and qualitative difference in NAS may be explained by the partial mu-receptor agonist and kappa-antagonist receptor profile of buprenorphine compared to pure mu-agonist action of methadone or heroin.
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Drug Alcohol Depend. 2001 Jun 1;63(1):97-103.
Buprenorphine treatment of pregnant opioid--dependent women: maternal and neonatal outcomes.
Johnson RE, Jones HE, Jasinski DR, Svikis DS, Haug NA, Jansson LM, Kissin WB, Alpan G, Lantz ME, Cone EJ, Wilkins DG, Golden AS, Huggins GR, Lester BM.
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, MD 21224-6823, USA.
This open-label prospective study examined maternal and neonatal safety and efficacy outcome measures during and following prenatal buprenorphine exposure. Three opioid-dependent pregnant women received 8 or 12 mg sublingual buprenorphine tablets daily for 15-16 weeks prior to delivery. Results showed that buprenorphine in combination with comprehensive prenatal care was safe and effective in these women. Prenatal exposure to buprenorphine resulted in normal birth outcomes, a mean of 4.33 days (minimum possible=4) hospitalization, and a 'relatively mild' neonatal abstinence syndrome comprised primarily of tremors (disturbed), hyperactive moro and shortened sleep after feeding. The infants required no pharmacological treatment. Onset of neonatal abstinence signs occurred within the first 12 h after birth, peaked by 72 h and returned to below pre-12 h levels by 120 h. It is concluded that buprenorphine has potential utility for the treatment of pregnant opioid-dependent women.
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Ann Med Interne (Paris). 2001 Nov;152 Suppl 7:21-7.
[Withdrawal syndromes of newborns of pregnant drug abusers maintained under methadone or high-dose buprenorphine: 246 cases]
[Article in French]
Lejeune C, Aubisson S, Simmat-Durand L, Cneude F, Piquet M, Gourarier L; Groupe d'Etudes Grossesse et addictions.
Groupe d'Etudes Grossesse et Addictions , Service de Neonatologie, Hopital Louis-Mourier, 92701 Colombes.
[email protected]
Perinatal prognosis of pregnant drug abusers is better with intensive prenatal care and substitution maintenance programs. There is a large body of data in the literature on methadone (MTD), but very little on high-dose buprenorphine (HDB). The objective of this study was to compare 2 groups of pregnant women maintained on MTD or HDB for perinatal events. STUDY DESIGN: Prospective multicentric study; all neonates (NN) whose mothers has been maintained during pregnancy on MTD or HDB were included by 34 French perinatal centers with specialized staff for care of these pregnant drug abusers. RESULTS: Two hundred and forty-six pregnant women were included: 93 (38%) MTD and 153 (62%) HDB. Social and perinatal data, prenatal care and factors correlated with poor prenatal care are reported. Forty-six percent of the pregnant women had good prenatal care; 88% had peridural analgesia; mean birthweight=2838g; mean gestational age=38.7 weeks; prematurity
7 weeks=13; intra-uterine growth retardation=32%. Sixty-five percent neonates had withdrawal neonatal syndrome (WNNS) at a mean age of beginning at H40, mean highest Lipsitz score was 8.2 at H78. Half of the neonates with WNNS received treatment, mainly with morphine chlorhydrate. Neonatal mortality was 0/246. Discharge of the neonates was 60% with their father and their mother, and 32% with their mother alone; 4% were placed in foster homes by judicial decision. The only statistically significant differences between the MTD and HDB groups were: maintenance program was more frequently initiated before this pregnancy for the HDB vs MTD group (p<0.03); MTD maintenance was more often supervised by maintenance specialized centers and HDB by general practitioners (p<0.001); prematurity was 18% for MTD group vs 9% for HDB group (p<0.04); mean age of maximum Lipsitz score was H92 for MTD group vs H70 for HDB group (p<0.001). CONCLUSIONS: The perinatal medical and social prognosis of these 246 pregnant drug abusers and of their neonates appeared to be improved by the specialized prenatal care, comparatively with literature data. Perinatal impact of substitution program during pregnancy would be similar with MTD or HDB.
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Drug Alcohol Depend. 2003 May 21;70(2 Suppl):S87-S101.
Use of buprenorphine in pregnancy: patient management and effects on the neonate.
Johnson RE, Jones HE, Fischer G.
Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 21224, Baltimore, MD, USA
It is estimated that 55-94% of infants born to opioid-dependent mothers in US will show signs of opioid withdrawal. Buprenorphine has been reported to produce little or no autonomic signs or symptoms of opioid withdrawal following abrupt termination in adults. To date, there have been 21 published reports representing approximately 15 evaluable cohorts of infants exposed to buprenorphine in utero. Of approximately 309 infants exposed, a neonatal abstinence syndrome (NAS) has been reported in 62% infants with 48% requiring treatment; apparently greater than 40% of these cases are confounded by illicit drug use. The NAS associated with buprenorphine generally appears within 12-48 h, peaks at approximately 72-96 h, and lasts for 120-168 h. These results appear similar to or less than that observed following in utero exposure to methadone. From a review of the literature, buprenorphine appears to be safe and effective in both mother and infant with an NAS that may differ from methadone both qualitatively and quantitatively.
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J Pharmacol Exp Ther. 2002 Jan;300(1):26-33.
Transplacental transfer and metabolism of buprenorphine.
Nanovskaya T, Deshmukh S, Brooks M, Ahmed MS.
Division of Pharmacology, School of Medicine, University of Missouri, Kansas City, Missouri 64108-2792, USA.
Information on the direct and indirect effects of buprenorphine (BUP) on the fetus is essential for determining its potential for treatment of the pregnant opiate addict. The goal of this investigation is to determine the transplacental transfer of BUP to the fetal circulation, its metabolism, and effects on the tissue. The technique of dual perfusion of placental lobule is used. The range of BUP concentrations investigated included its peak plasma levels (10 ng/ml) in patients under treatment. A biphasic decline in concentration of the drug in the maternal circulation was observed, initially rapid then slow. During the initial (60 min), the tissue sequestered most of BUP resulting in a low (<10%) transplacental transfer of the drug to the fetal circulation. The concentration ratios of the drug in tissue/maternal and tissue/fetal were 13 +/- 6.5 and 27.4 +/- 0.4. The drug sequestered did not have any adverse effects on placental tissue viability and functional parameters. Less than 5% of the perfused BUP was metabolized to norbuprenorphine during the 4 h of perfusion and the metabolite was distributed between the tissue, maternal, and fetal circulations. Taken together, these data suggest that the therapeutic levels of BUP in the maternal circulation may have no indirect effects (via the placenta) on the fetus. The observed low transplacental transfer of BUP to the fetal circuit may explain the moderate/absence of neonatal withdrawal in the limited number of reports on mothers treated with the drug during pregnancy.
