Ranexa Pregnancy Warnings
UK: This drug should not be used during pregnancy unless clearly needed.
US: The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Risk Summary: Animal studies failed to reveal evidence of fetal harm at exposures 4 times the maximum recommended human dose (MRHD).
Animal studies revealed decreased fetal weight and reduced ossification at doses (corresponding to 4-fold the AUC for the MRHD) that caused maternal weight loss. There are no controlled data in human pregnancy.
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.
See references
