Salagen Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no adequate and well-controlled study data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Some experts recommend against using this drug in patients of childbearing potential who are not using contraception and/or during pregnancy.
-Use of adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have revealed evidence of embryolethality, fetolethality, fetal harm (e.g., decreased fetal body weight, increased fetal skeletal variations), and impaired fertility/reproductive toxicity at potentially maternotoxic doses. Evidence of decreased sperm motility, impaired spermatogenesis, morphological evidence of abnormal sperm, and reduced fertility were observed in male animal models given 3 mg/kg per 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.
See references
Salagen Breastfeeding Warnings
In animal models, milk excretion levels were similar to those in plasma levels.
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
The effects in the nursing infant are unknown.
-This drug is considered compatible with breastfeeding by the WHO.
-Some experts state that use of an alternative oral drug may be considered, especially when nursing a preterm or newborn infant.
See references
