Loniten Pregnancy Warnings
Animal studies have revealed evidence of increased fetal resorption when administered at 5 times the maximum recommended human dose. No evidence of teratogenicity was reported. Neonatal hypertrichosis has been reported following exposure during pregnancy. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Use is not recommended.
-According to some authorities, this drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comments:
-Use of adequate methods of contraception should be encouraged.
-Use should be avoided in women of childbearing potential who are not using contraception.
See references