Can niacinamide plus tranexamic acid (TXA) topical be used during pregnancy?

Safety of Topical Niacinamide Plus Tranexamic Acid During Pregnancy

Topical niacinamide plus tranexamic acid formulations can be used with caution during pregnancy, with tranexamic acid preferably used after the first trimester.

Safety Profile of Individual Components

Tranexamic Acid

• Tranexamic acid has been used systemically during pregnancy for hemorrhage management with a good safety profile 1
• For topical use specifically, limited data exists on safety during pregnancy
• Guidelines suggest that when systemic tranexamic acid is needed during pregnancy, it should preferably be used after the first trimester 2
• The FDA label for tranexamic acid notes that it crosses the placenta, but animal reproduction studies have not identified adverse developmental outcomes 3

Niacinamide

• Niacinamide is considered relatively safe in topical formulations
• The International Journal of Toxicology safety assessment reports that niacinamide is non-toxic at levels considerably higher than those used in cosmetic products 4
• No specific contraindications for topical niacinamide use during pregnancy have been established

Risk Assessment for Topical Application

Systemic Absorption Considerations

• Topical medications generally have minimal systemic absorption compared to oral or parenteral routes 5
• The concentration of niacinamide in cosmetic formulations typically ranges from 0.0001% to 3%, with most topical products containing 2% 4, 6
• Topical tranexamic acid is typically used at concentrations around 2% 6

Comparative Risk Analysis

• Unlike retinoids (such as tazarotene) which are explicitly contraindicated in pregnancy 2, 7, neither niacinamide nor topical tranexamic acid carries specific pregnancy contraindications
• The primary concern with tranexamic acid would be its potential antifibrinolytic properties, though systemic absorption from topical application is expected to be minimal

Clinical Recommendations

Approach to Use During Pregnancy

1. First Trimester Considerations

   • Exercise greater caution during the first trimester when organogenesis occurs
   • Consider postponing use until after the first trimester if possible

2. Application Guidelines

   • Apply to limited body surface areas to minimize potential systemic absorption
   • Avoid application to broken or inflamed skin where absorption may be increased
   • Use the minimum effective amount

3. Monitoring

   • Monitor for any signs of skin irritation or systemic effects
   • Discontinue use if any adverse reactions occur

Common Pitfalls and Caveats

• Avoiding Combination with Hormonal Contraceptives: If significant systemic absorption of tranexamic acid occurs, there is a theoretical risk of increased thrombotic events when combined with hormonal contraceptives 3
• Distinguishing Between Topical and Systemic Risk: Most safety data for tranexamic acid comes from systemic administration studies, which may overestimate risks from topical application
• Limited Research: The specific combination of niacinamide and tranexamic acid in pregnancy has not been extensively studied

Alternative Options

If there are concerns about using this combination during pregnancy:

• Consider using niacinamide alone, which has a better-established safety profile
• Discuss other pregnancy-safe hyperpigmentation treatments with a dermatologist

While the available evidence suggests that topical niacinamide plus tranexamic acid can be used with caution during pregnancy, the decision should be made after weighing the benefits against the potential risks, with greater caution exercised during the first trimester.