Summary of Use during Lactation

Data on excretion of diclofenac into milk are poor, but the drug has a short half-life and little glucuronide metabolite formation. Levels in milk appear to be quite low. Most reviewers consider diclofenac to be acceptable during breastfeeding.[1-5] Other agents having more published information may be preferred, especially while nursing a newborn or preterm infant.[6]

Maternal use of diclofenac topical gel or eye drops would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug Levels

Diclofenac was undetectable (<100 mcg/L) in the breastmilk over a 6-hour period after a 50 mg intramuscular injection in 6 women.[7,8]

Six mothers were given oral diclofenac 100 mg daily orally for one week postpartum. The drug was undetectable(<10 mcg/L) in milk of any of 59 samples of milk collected (collection times unspecified).[8]

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.[9]

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.[10] 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.

Effects in Breastfed Infants

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.[11]

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.[12]

Effects on Lactation and Breastmilk

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]

Alternate Drugs to Consider

(Systemic) Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen, Piroxicam

References

1.

Brooks PM, Needs CJ. Antirheumatic drugs in pregnancy and lactation. Baillieres Clin Rheumatol 1990;4:157-71. [PubMed: 2282661]

2.

Østensen ME. Safety of non-steroidal anti-inflammatory drugs during pregnancy and lactation. Inflammopharmacology 1996;4:31-41. doi:10.1007/BF02735557 [CrossRef]

3.

Spigset O, Hägg S. Analgesics and breast-feeding: Safety considerations. Paediatr Drugs 2000;2:223-38. [PubMed: 10937472]

4.

Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy and lactation. Arch Intern Med 2000;160:610-9. [PubMed: 10724046]

5.

MacGregor EA. Migraine in pregnancy and lactation. Neurol Sci 2014;35 (Suppl 1):61-4. [PubMed: 24867839]

6.

Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol 2014;70:1313-24. [PubMed: 25217187]

7.

Fowler PD. Voltarol: Diclofenac sodium. Clin Rheum Dis 1979;5:427-64.

8.

Sioufi A, Stierlin H, Schweizer A, et al. Recent findings concerning clinically relevant pharmacokinetics of diclofenac sodium. In, Kåss E. Voltaren--new findings. Bern. Hans Huber Publishers. 1982:19-30.

9.

Todd PA, Sorkin EM. Diclofenac sodium. A reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 1988;35:244-85. [PubMed: 3286213]

10.

Tamaki R, Noshiro K, Furugen A, et al. Breast milk concentrations of acetaminophen and diclofenac - unexpectedly high mammary transfer of the general-purpose drug acetaminophen. BMC Pregnancy Childbirth 2024;24:90. [PMC free article: PMC10826108] [PubMed: 38287321]

11.

Hirose M, Hara Y, Hosokawa T, Tanaka Y. The effect of postoperative analgesia with continuous epidural bupivacaine after cesarean section on the amount of breast feeding and infant weight gain. Anesth Analg 1996;82:1166-9. [PubMed: 8638785]

12.

De Cerqueira AM, De Azevedo JO, Guimaraes MB, Afradique MC. Urticaria in a newborn. J Am Acad Dermatol 2009;60 (3 Suppl 1):Abstract 148.

13.

Hooda R, Malik N, Pathak P, et al. Impact of postoperative pain on early initiation of breastfeeding and ambulation after cesarean section: A randomized trial. Breastfeed Med 2023;18:132-7. [PubMed: 36800334]

Substance Name

Diclofenac

CAS Registry Number

15307-86-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Analgesic Agents

Nonsteroidal Antiinflammatory Agents