Is Diclofenac safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Diclofenac. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
In one study, 30 mothers undergoing elective cesarean section were allowed to use 25 mg diclofenac suppositories along with either spinal or spinal and epidural anesthesia with a local anesthetic after delivery. The spinal anesthetic group used an average of 56 mg of diclofenac on the day of delivery and 33 mg on the next day whereas the women receiving both spinal and epidural anesthesia used 21 and 18 mg. No mention was made of adverse effects on the breastfed infants.[ 10 ] A breastfed infant developed urticaria on day 15 of life. Her mother had been taking diclofenac (dosage unspecified) for pain since her cesarean section delivery. Diclofenac is a possible cause of the urticaria; however, the infant had also received hepatitis B vaccination 7 days before and the authors thought that it was a more likely cause of the reaction.[ 11 ] A trial in women who received a cesarean section randomized participants to receive 2 tablets of acetaminophen 325 mg and tramadol 35.5 mg (Zaldiar, Gruenthal, Israel) every 6 hours as well as diclofenac 100 mg at 12, 24 and 48 hours after arrival in the maternity ward, either as a fixed dose or the same drugs on demand. No differences were noted in neonatal outcomes of peak bilirubin, need for phototherapy, and adverse effects, including irritability or altered consciousness. No adverse infant effects were seen.[ 12 ]
Effects on milk supply
A trial in women who received a cesarean section randomized participants to receive 2 tablets of acetaminophen 325 mg and tramadol 35.5 mg (Zaldiar, Gruenthal, Israel) every 6 hours as well as diclofenac 100 mg at 12, 24 and 48 hours after arrival in the maternity ward, either as a fixed dose or the same drugs on demand. Patients on the fixed dose regimen had more breastfeeds (23.8 vs 19.2) and fewer instances of formula (8.2 vs 11.9) than the on demand group.[ 12 ] A randomized, double-blind study was performed in pregnant women scheduled for cesarean section under spinal anesthesia with bupivacaine and fentanyl. Patients received either 100 mg diclofenac (n = 100), 100 mg tramadol (n = 100) or placebo (glycerin suppositories) n = 100, all given as rectal suppositories every 8 hours for the first 24 hours after surgery. The time to initiate breastfeeding was significantly shorter among mothers who received diclofenac than a placebo, 1.5 vs 4.1 hours with breastfeeding support and 3.5 vs 6.2 hours without support. Diclofenac was slightly more effective than tramadol among mothers who received no support (3.5 vs 3.7 hours).[ 13 ]
Levels in milk
Diclofenac was undetectable ( 100 mcg/L) in the breastmilk over a 6-hour period after a 50 mg intramuscular injection in 6 women.[ 7 ] Six mothers were given oral diclofenac 100 mg daily for one week postpartum. The drug was undetectable ( 10 mcg/L) in milk of any of 59 samples of milk collected (collection times unspecified).[ 7 ] A woman treated with 150 mg daily of diclofenac had a breastmilk diclofenac level of 100 mcg/L, equivalent to about 0.03 mg/kg daily for the infant.[ 8 ] Fifteen women taking diclofenac 25 mg orally (n = 11) or a 50 mg suppositories (n = 4) for postpartum pain donated a total of 20 milk samples for analysis at random times at 5 to 6 days postpartum. Nine of the women taking oral diclofenac had undetectable ( 0.5 mcg/L) milk concentrations at times ranging from 2 to 64 hours after a dose. Milk levels from 0.84 to 3.89 mcg/L were found in 4 milk samples at times ranging from 3 to 10 hours after a dose. In the 4 women taking a 50 mg suppository, 3 milk diclofenac levels ranged from 0.56 to 1.63 mcg/L at times ranging from 7 to 16.5 hours after a dose. In one woman, diclofenac was undetectable in milk 54 hours after a dose.[ 9 ] Note that this paper does not state the number of doses taken prior to sampling, so steady-state is not guaranteed. The pharmacokinetic analysis of samples was performed in an invalid way, and pharmacokinetic parameters reported in the paper are therefore not valid.
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.