Can topical diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) be prescribed during breastfeeding?

From the Guidelines

Topical diclofenac can be prescribed during breastfeeding with minimal risk. When considering the use of topical diclofenac in breastfeeding women, it's essential to weigh the benefits against the potential risks to the infant. According to the guideline on anaesthesia and sedation in breastfeeding women 2020 from the Association of Anaesthetists 1, diclofenac is considered safe to use during breastfeeding, as only small amounts are detected in breast milk.

Key Considerations

• The amount of diclofenac that enters the bloodstream and subsequently transfers into breast milk is extremely small, posing minimal risk to the nursing infant.
• The guideline suggests that diclofenac, along with other NSAIDs like ibuprofen and naproxen, can be used during lactation without significant concern for adverse effects on the infant 1.
• It's crucial to use the lowest effective dose for the shortest duration needed and avoid applying topical diclofenac to large areas of skin or broken skin to minimize absorption.
• Applying the medication directly on or near the breasts should be avoided to prevent direct contact or ingestion by the infant.

Comparison with Other Options

• Topical diclofenac is generally considered a safer option than oral NSAIDs for pain relief during breastfeeding, as it reduces systemic absorption and the potential for infant exposure.
• Other NSAIDs, such as ibuprofen and naproxen, are also considered safe during breastfeeding, but the choice of medication should be based on the individual patient's needs and medical history 1.

Monitoring and Precautions

• If unusual symptoms are observed in the baby after the mother uses topical diclofenac, it's essential to contact a healthcare provider promptly.
• Breastfeeding women should inform their healthcare provider before starting any medication, including topical diclofenac, to ensure safe and effective use.

From the FDA Drug Label

Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for diclofenac sodium topical solution and any potential adverse effects on the breastfed infant from the diclofenac sodium topical solution or from the underlying maternal condition Data One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day. Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period)

Topical diclofenac use during breastfeeding:

• The drug label indicates that diclofenac may be present in human milk.
• However, the amount of diclofenac in breast milk is expected to be low, with one study showing an infant dose of about 0.03 mg/kg/day.
• Caution is advised when prescribing topical diclofenac to breastfeeding mothers, as the potential adverse effects on the breastfed infant are not well established 2.
• The benefits of breastfeeding and the mother's need for the medication should be weighed against the potential risks to the infant.

From the Research

Topical Diclofenac Use During Breastfeeding

• The use of topical diclofenac during breastfeeding has been studied in relation to its transfer into breast milk and potential effects on the infant 3.
• A study found that diclofenac sodium showed low mammary transfer, with a milk-to-plasma drug concentration ratio of 0.093, indicating that it is unlikely to pose a significant risk to breastfed infants 3.
• Another study reviewed the safety of various medications during breastfeeding and listed diclofenac as a medication that is compatible with breastfeeding but warrants caution 4.
• However, there is limited information available on the specific use of topical diclofenac during breastfeeding, and most studies have focused on oral administration 5, 6.
• It is essential to consult current, accurate resources, such as LactMed, for the most up-to-date information on medication safety during breastfeeding 5.

Medication Safety During Breastfeeding

• When prescribing medications for breastfeeding patients, those with the lowest risk to the infant should be selected, and dosing should be before the infant's longest sleep interval 5.
• Acetaminophen and ibuprofen are preferred analgesics during lactation, while stimulant medications may decrease milk supply 5.
• Nonhormonal and progestin-only contraceptives are preferred over combination oral contraceptives during breastfeeding 5.
• The safety of various medications during breastfeeding has been studied, and resources like LactMed provide valuable information for healthcare providers 5, 6.