Safety of Tamsulosin (Flomax) During Breastfeeding
Tamsulosin (Flomax) should not be used during breastfeeding due to lack of safety data and the availability of safer alternatives for treating urinary conditions in breastfeeding women.
Evidence Assessment
The FDA label for tamsulosin (Flomax) explicitly states that it is "not indicated for use in women" 1. This clear contraindication is the strongest evidence available regarding its use in breastfeeding women.
While the FDA label doesn't specifically address breastfeeding beyond stating it's not indicated for women, this absence of safety data is significant. When evaluating medication safety during lactation, medications without established safety profiles should be avoided when alternatives exist.
General Principles for Medication Use During Breastfeeding
When evaluating medication safety during breastfeeding, several factors should be considered:
- The relative infant dose (RID) - values <10% are generally considered safe 2
- The medication's pharmacokinetic properties (half-life, protein binding, molecular weight)
- The infant's age and health status
- The availability of safer alternatives
Unfortunately, there are no published studies on tamsulosin excretion into breast milk or its effects on breastfed infants.
Safer Alternatives for Urinary Conditions
For urinary conditions in breastfeeding women that might otherwise be treated with tamsulosin:
- Non-pharmacological approaches should be first-line (adequate hydration, timed voiding)
- For urinary tract infections requiring antibiotics:
Important Considerations
Risk-benefit assessment: The benefits of treating maternal conditions often outweigh potential risks to the infant, but only when using medications with established safety profiles.
Monitoring: If a medication with limited safety data must be used, monitor the infant for:
- Changes in feeding patterns
- Unusual drowsiness
- Irritability or other behavioral changes 4
Timing: When feasible, take medications immediately after breastfeeding to minimize concentration in milk during the next feeding.
Conclusion
Based on the FDA labeling that tamsulosin is "not indicated for use in women" 1 and the complete absence of safety data for breastfeeding, tamsulosin should be avoided during lactation. Healthcare providers should select alternative treatments with established safety profiles for breastfeeding women requiring treatment for urinary conditions.