What pregnancy category is assigned to Irbesartan?

Irbesartan is assigned to Category D in terms of pregnancy risk. This classification indicates that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits may warrant use of the drug in pregnant women despite those risks. In the case of irbesartan, it is important to note that its use during pregnancy can potentially cause serious harm to the developing fetus, particularly when used during the second and third trimesters due to its effect on fetal renal function and the development of skull hypoplasia.

While Category A indicates no risk in controlled human studies, and Category B suggests no proven risk in humans, these do not apply to irbesartan. Category C denotes that animal studies have shown an adverse effect, but there are no adequate studies in humans. However, irbesartan's classification as Category D underscores the heightened risk associated with its use during pregnancy, which is why it is not appropriate for use in that population unless absolutely necessary.

Understanding these classifications can help guide safer medication practices for pregnant patients, ensuring both maternal and fetal safety.