What are the effects of Amitriptyline (Triptizol) on pregnancy?

From the Guidelines

Triptizol should be used with caution during pregnancy, and only under the strict supervision of a specialist, due to limited safety data and potential risks to the fetus. According to a recent study published in Nature Reviews Neurology 1, preventive migraine medications, including triptans like Triptizol, are best avoided during pregnancy owing to the potential for fetal harm. However, if preventive therapy is considered clinically indicated because of frequent and disabling migraine attacks, the best available safety data support the use of propranolol or, if propranolol is contraindicated, amitriptyline, under specialist supervision. Some key points to consider when using Triptizol during pregnancy include:

• The potential for harm to the fetus demands special consideration
• Triptans should be used only under the strict supervision of a specialist
• The safety data available are limited and originate from post-marketing surveillance
• Most data relate to the use of sumatriptan, not Triptizol specifically
• If Triptizol is deemed necessary during pregnancy, the lowest effective dose should be used, and both the mother and baby should be monitored closely throughout the pregnancy. It is essential to consult a healthcare provider immediately to discuss the specific situation and determine the best course of action, as the decision to use Triptizol during pregnancy requires balancing the mother's health needs against potential risks to the developing fetus 1.

From the FDA Drug Label

Usage in Pregnancy Pregnancy Category C Teratogenic effects were not observed in mice, rats, or rabbits when amitriptyline was given orally at doses of 2 to 40 mg/kg/day (up to 13 times the maximum recommended human dose 1) Studies in literature have shown amitriptyline to be teratogenic in mice and hamsters when given by various routes of administration at doses of 28 to 100 mg/kg/day (9 to 33 times the maximum recommended human dose), producing multiple malformations Another study in the rat reported that an oral dose of 25 mg/kg/day (8 times the maximum recommended human dose) produced delays in ossification of fetal vertebral bodies without other signs of embryotoxicity. In rabbits, an oral dose of 60 mg/kg/day (20 times the maximum recommended human dose) was reported to cause incomplete ossification of cranial bones Amitriptyline has been shown to cross the placenta. Although a causal relationship has not been established, there have been a few reports of adverse events, including CNS effects, limb deformities, or developmental delay, in infants whose mothers had taken amitriptyline during pregnancy. There are no adequate and well-controlled studies in pregnant women Amitriptyline hydrochloride should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

The drug Amitriptyline (also known as Triptizol) is classified as Pregnancy Category C.

• Teratogenic effects have been observed in some animal studies at high doses.
• There are no adequate and well-controlled studies in pregnant women.
• The drug should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus 2.

From the Research

Triptizol and Pregnancy

• Triptizol, also known as amitriptyline, is a tricyclic antidepressant that may be used during pregnancy in some cases 3.
• The use of antidepressants during pregnancy, including triptizol, has been associated with potential risks to the fetus, such as cardiac malformations, primary pulmonary hypertension of the newborn infant, or poor neonatal adaptation syndrome 3.
• However, the benefits of treating depression with antidepressants during pregnancy may outweigh the potential risks, especially when considering the impact of untreated depression on the mother and child 4, 3.
• A systematic review and meta-analysis found that mothers exposed to antidepressants during pregnancy, including triptizol, were at a significantly increased risk for gestational diabetes mellitus (GDM), but this association may be overestimated due to confounding by indication 5.
• Subgroup analysis suggested that the risk of GDM was increased by venlafaxine or amitriptyline (triptizol) use, but not by selective serotonin reuptake inhibitors 5.
• It is essential to weigh the potential benefits and risks of using triptizol during pregnancy and to consider the individual circumstances of each patient 6, 7.

Key Considerations

• The decision to use triptizol during pregnancy should be made on a case-by-case basis, taking into account the severity of the depression, the potential risks and benefits of treatment, and the individual patient's circumstances 4, 3.
• Healthcare providers should discuss the potential risks and benefits of triptizol use during pregnancy with their patients and provide them with accurate and up-to-date information to make informed decisions 6, 7.