Doptelet Pregnancy Warnings
This drug is not recommended during pregnancy and in women of childbearing potential not using contraception.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on animal studies, this drug may cause fetal harm.
Comments:
-Advise pregnant women of the potential risk to a fetus.
- Advise females of childbearing potential to use contraception if treated with this drug.
-Advise females to inform their prescriber of a known or suspected pregnancy.
Animal studies have revealed increased pup mortality at a dose that resulted in maternal exposures 43-times and pup exposures approximately 3-times the AUC observed in patients at the maximum recommended dose of 60 mg once a day. 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.
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