Vyndamax Pregnancy Warnings
In animal studies with pregnant rabbits, embryofetal mortality, fetal body weight reduction and fetal malformation were observed at doses approximately 9 times the maximum recommended human dose (MRHD); an increased incidence of fetal skeletal variation was observed at a dose estimated to be equivalent to the MRHD. In pregnant rats receiving 2 times the MRHD of this drug during gestation and lactation, postnatal mortality, growth retardation, and impaired learning and memory were observed in their offspring. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk Summary: Limited available human data for use in pregnant women (at a dose of 20 mg/day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, based on animal studies, this drug may cause fetal harm.
Comments:
-Consider pregnancy planning and prevention for females of reproductive potential; women of childbearing potential should use contraceptive measures during treatment and for one month after the last dose.
-In the US, pregnancy should be reported to Pfizer at 1-800-438-1985; in Australia, pregnancy should be reported to the Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO) program (Pfizer, Australia: 1-800-675-229)
See references
