Tryptomer (Amitriptyline) in Pregnancy
Amitriptyline can be used during pregnancy when clinically indicated, as current evidence suggests it is relatively safe with no confirmed increased risk of major congenital malformations, though the FDA label advises consulting a health professional before use. 1, 2
Safety Profile
Amitriptyline is among the tricyclic antidepressants (TCAs) with the most clinical experience during pregnancy and can be considered a reasonable treatment option. 2
- Nortriptyline, amitriptyline, and clomipramine can be used during pregnancy, though data are more abundant for SSRI treatment 2
- The FDA drug label for Tryptomer states to "ask a health professional before use" if pregnant or nursing, indicating caution but not absolute contraindication 1
- TCAs fall into FDA Category C, meaning potential benefits may justify potential risks to the fetus 3
Risk Assessment
The primary concern with amitriptyline relates to anticholinergic effects rather than teratogenicity:
- Common adverse effects include somnolence, dry mouth, blurred vision, constipation, weight gain, and prolonged QTc on ECG 3
- One study found TCAs were associated with eye, ear, face and neck defects (aOR 2.45,95% CI 1.05-5.72) and digestive defects (aOR 2.55,95% CI 1.40-4.66), though this was in the context of antidepressants with serotonin reuptake effects 4
- No drug is entirely without side-effects, and great caution should be taken when prescribing in pregnancy 5
Clinical Management
When prescribing amitriptyline during pregnancy:
- Start with 25 mg at bedtime, with slow titration (10-25 mg increments every 2 weeks) up to goal dosage of 75-150 mg or 1-1.5 mg/kg at bedtime 3
- Dose at night to minimize daytime sedation 3
- Amitriptyline may have more anticholinergic/antihistaminergic activity than nortriptyline, which could be a consideration when choosing between TCAs 3
- The medication dosage for women is generally the same regardless of whether they are pregnant, though therapeutic options might be limited and patients should be managed individually 3
Important Caveats
Key considerations when using amitriptyline in pregnancy:
- The benefits of treating depression often outweigh potential risks, as untreated depression during pregnancy is associated with premature birth, decreased initiation of breastfeeding, and potential harmful effects on the mother-infant relationship 6
- Drugs should be given only if potential benefits justify the potential risk to the fetus 3, 7
- Drug safety in pregnancy demands continuous collection of observational data to assess risks as precisely as possible 8
Lactation
Amitriptyline can be used during breast-feeding. 2