Journal of Human Lactation

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Fentanyl Transdermal Analgesia During Pregnancy and Lactation

Ronald S. Cohen
J Hum Lact 2009 25: 359 originally published online 13 March 2009
DOI: 10.1177/0890334409333475

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 Case Report

Fentanyl Transdermal Analgesia During Pregnancy and Lactation

Ronald S. Cohen, MD

Abstract
This report describes an infant who was born to a mother with chronic pain treated with fen-
tanyl 100 µg/h transdermal patch throughout her pregnancy and during lactation. On day of
life 27, when the baby was feeding and gaining weight on maternal milk, samples of the baby’s
blood and maternal milk were sent for analysis. The mother’s milk fentanyl level was 6.4 ng/
mL. The infant’s blood fentanyl level was undetectable. This preliminary report suggests that
fentanyl transdermal patch treatment might be a viable option for managing chronic pain dur-
ing lactation. J Hum Lact. 25(3):359-361.
Keywords:  drug use; human milk; pharmacology

Chronic pain treatment during pregnancy1 and lacta- Case Report

tion2 can be a difficult problem. Care must be taken to
The mother was a 35-year-old primigravida woman
ensure adequate pain relief during pregnancy while
with complex medical problems including severe asthma,
minimizing the risks to the fetus of teratogenicity,
multiple allergies, and severe back pain from multiple
intrauterine withdrawal, or growth restriction.3-5 After
herniated disks including C5, C6, L4, and L5. She had
birth, the exposed neonate may be at risk for narcotic
limited ambulation, needed a wheelchair most of the
abstinence syndrome (NAS) from maternal treatment.
time, and had weakness of her arms attributable to
Pain management postpartum is complicated by con-
cervical radiculopathy. Past history included renal stones
cerns regarding exposure of the neonate through
and transient cerebrospinal fluid (CSF) leakage years
breastfeeding6 as well as increased risk of maternal
ago after a negative diagnostic lumbar puncture
thromboembolism and interference with lactation from
performed for a positive PPD (tuberculosis skin test).
sedation.7-9 The American Academy of Pediatrics con-
Because of her allergies, she was strongly committed to
siders fentanyl use compatible with breastfeeding
breastfeeding her infant and registered at our hospital
based on short-term maternal use.6 This report describes
late in her pregnancy for management of her high-
successful breastfeeding of an infant born to a woman
risk delivery. Fetal ultrasonography showed growth
with chronic pain treated throughout both the preg-
consistent with dates and no physical anomalies. Pain
nancy and postpartum with a fentanyl 100 µg/h trans-
control was by fentanyl 100 µg/h transdermal patch
dermal patch. Fentanyl levels measured in both breast
changed every other day. Her last attempt to wean off
milk and baby’s serum were low.
fentanyl was about 5 years prior to conception and failed
because of inability to tolerate other medications,
Received for review October 28, 2008; revised manuscript accepted for including methadone. She did lower her dose from 200
publication February 1, 2009. to 100 µg/h at that time.
Ronald S. Cohen, MD, is clinical professor of pediatrics at Stanford She required a large amount of additional fentanyl
University and medical director of intermediate and special care nurseries during labor. In the 12 hours leading up to delivery, in
at the Lucile S. Packard Children’s Hospital. He is also medical director of addition to her baseline fentanyl patch, she received
the Mothers’ Milk Bank of San José, California.
fentanyl 35 µg per 6 minutes intravenously (IV) by
Address correspondence to Ronald S. Cohen, MD, Stanford University patient-controlled analgesia and 50 µg IV four times.
School of Medicine, Lucile S. Packard Children’s Hospital, 725 Welch
Road–IICN, Palo Alto, CA 94304; e-mail: rscohen@stanford.edu.
Delivery was by cesarean section attributable to failure
of descent of the fetal head and maternal intolerance of
J Hum Lact 25(3), 2009
DOI: 10.1177/0890334409333475
labor complicated by limited spine mobility, which
© Copyright 2009 International Lactation Consultant Association impaired optimal positioning of the mother. Spinal
359

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360 Cohen J Hum Lact 25(3), 2009
anesthesia was not an acceptable option given her
history of CSF leakage and back pain. For the opera­
tion, she received general anesthesia with inhaled
sevoflurane, propofol 200 mg IV, midazolam 2 mg IV,
and additional doses of fentanyl 100 µg IV five times
prior to cutting the umbilical cord. The baby girl was
assigned Apgar scores of 8 and 9 and was brought to
the newborn intensive care unit for monitoring of
anticipated NAS. Birth weight was 3.96 kg, with a
head circumference of 36 cm, and she was stable in
room air with no distress.
Her NAS scores10 climbed rapidly and were well in
the range indicating need for pharmacotherapy on the
first day of life. Withdrawal treatment was started with
morphine 0.08 mg orally every 4 hours at less than 24
hours of life, but her NAS scores remained high, and
the dose was increased to 0.16 orally every 4 hours,
0.16 mg orally every 3 hours, and then 0.20 mg orally
every 3 hours by the fourth day of life. Withdrawal
from oral morphine following her NAS scores was
slow and arduous over the next few weeks, mostly
because of irritability. She was finally able to stop
morphine completely on the 29th day of life and went
home 2 days later doing well.
The mother required increased pain medication
for her postoperative management. Her fentanyl was
increased to 125 µg/h transdermal patch, and
hydroco­done 10 mg with acetaminophen 1000 mg
orally every 4 hours was added. The baby was fed
pooled, pasteurized donor milk from the local milk
bank initially given the multiple maternal medications.
By about 2 weeks postpartum, the mother was off
other pain medications and back to only her baseline
treatment of fentanyl 100 µg/h patch. The baby then
was allowed to feed maternal milk either from a
bottle after being expressed, or directly from the
breast, as tolerated every 3 hours.
On the 27th day of life, a morning blood sample was
obtained from the baby after having fed 380 mL of
expressed maternal milk plus several feedings at
breast in the previous 24-hour period, including
60 mL maternal milk immediately prior to sampling.
A sample of freshly expressed maternal milk was
also obtained from a mixed total collection pumped
from one breast. With parental consent, both the blood
and the milk samples were sent for analysis using
liquid chromatography-tandem mass spectrometry
(Arup Laboratories, Willow Grove, Pa). The baby’s
blood was negative for both fentanyl and its metabolite
norfentanyl, with a sensitivity of 0.1 ng/mL. The
Downloaded from jhl.sagepub.com at Aston University - FAST on September 1, 2014
mother’s milk was positive for fentanyl 6.4 ng/mL and
norfentanyl 6.2 ng/mL. There were no other significant
medical problems with the baby, and she fed well,
gaining more than 500 g by discharge. She went home
doing well on maternal milk both at breast and from a
bottle. She moved back to the family’s home state
shortly thereafter and was lost to follow-up.
Discussion
Assuming that a healthy 1-month-old newborn might
ingest up to about 200 mL/kg daily of maternal milk,
the levels of fentanyl we found in this mother’s milk
would result in a total daily oral dose of up to 1.3 µg/
kg in divided doses over a 24-hour period. A study of
fentanyl levels in maternal milk after a single dose
showed similar low rates of transfer.11 Assuming
complete oral absorption of this drug, it seems highly
unlikely that such a rate of ingestion would have any
detectable impact on the baby. Wheeler et al12,13 studied
orally administered fentanyl in children undergoing
anesthesia. After a dose of 10 to 15 µg/kg in liquid
form, the investigators found absorption similar to oral
transmucosal fentanyl lozenges, with slightly more
than one third of the dose absorbed. The total daily
dose our infant might have been exposed to was about
10% of the one-time oral dose studied. Oral transmucosal
fentanyl has been shown to be able to provide effective
analgesia in children,14 but again at doses of 10 to 15
µg/kg. Even if fully absorbed, the total daily oral dose
would approximate the recommended hourly dose for
continuous intravenous infusion.15
This neonate developed significant NAS, requiring
prolonged treatment with oral morphine, which
reportedly results in shorter term treatment than
alternatives.16,17 In one case report,18 maternal treatment
with fentanyl 125 µg/h transdermal patch during the
entire pregnancy resulted in minimal withdrawal
symptoms and fairly low blood concentrations in
the newborn at birth. Because variations in individual
drug responses make it difficult to correlate maternal
opiate dose with degree of NAS,19,20 the risk of NAS
remains with chronic intrauterine exposure to any
opiate.
One study showed that maternal methadone treat­
ment, when used for chronic maternal pain, may
result in milder NAS withdrawal symptoms for the
neonate than when used for maternal addiction,
although the pain group required lower doses and
shorter courses.21 If this mother had been treated with
methadone, it is likely she would have required a
J Hum Lact 25(3), 2009 Fentanyl Transdermal Analgesia 361
long course and high dose, more like the maternal
addiction group, all of whose offspring developed
NAS. Methadone transmission into maternal milk is
greater than fentanyl but reportedly is well tolerated
by breastfed infants.22,23 However, in the United
States, methadone is difficult for most primary care
practitioners to use for out­patient pain management.
Transdermal patch fentanyl is easy to prescribe,
obtain, and use. Although improved neonatal outcome
with increased maternal methadone dose has been
reported,24 recent reports raise concerns regarding the
long-term outcome of neonates exposed to opiates in
utero.25 Other, common oral pain relievers contain
codeine. However, recent reports raise significant
concerns about the use of codeine during breastfeeding
given genetic variations in metabolism.26 Thus, an
alternative treatment for chronic pain may be
needed.
These results suggest that if an opioid drug is
needed to provide long-term pain relief for a lactating
woman, fentanyl transdermal patch might be an
appropriate alternative. Care would have to be taken to
monitor the child closely, and the lowest dose necessary
should be used. If maternal treatment is started during
the pregnancy, then NAS would be a concern, as it
would be with other opiates, and the possible long-
term implications of this are unclear. However, this
preliminary report suggests that fentanyl transdermal
patch treatment might be viable option for pain
management of postpartum patients.
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