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Tafamidis Pregnancy and Breastfeeding Warnings

Tafamidis is also known as: Vyndamax, Vyndaqel

Medically reviewed by Drugs.com. Last updated on Sep 6, 2019.

Tafamidis Pregnancy Warnings

Animal studies have revealed increased embryofetal mortality, reduced fetal body weight, and increased incidences of fetal malformations at approximately 9 to 10 times the human exposure at the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%. During gestation and lactation in offspring of pups, postnatal mortality, growth retardation, and impaired learning and memory have been observed at a dosage approximately two times the MRHD based on body surface area (mg/m2).

Advise the patient to report pregnancies to the Pfizer reporting line at 1-800-438-1985.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Comments: Patients of childbearing potential should not use this drug unless contraceptive measures are in place during treatment and for one month after the last dose.

See references

Tafamidis Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Vyndaqel (tafamidis)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. "Product Information. Vyndaqel (tafamidis)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.