May 22 2022

Classification of the active ingredient aliskiren


Risk level in pregnancy: This medicine is classified as Category D.

There are no controlled studies or clinical experience on the use of aliskiren in pregnancy.

All direct inhibitors of the renin-angiotensin system (RAS) can cause fetal damage during the second and third trimesters of pregnancy.

On the other hand, ACE inhibitors, medications that also act on the RAS have been associated with a potential risk of birth defects when they are used during the first trimester of pregnancy, according to the analysis of retrospective data.

The medical literature contains several dozen cases of severe adverse effects attributed to fetal or neonatal RAS inhibitor use during pregnancy, including hypotension, neonatal skull hypoplasia, anuria, renal failure, reversible or not, and stillbirth.

have been published oligohidramnios cases, probably due to the decrease in renal function of the fetus. Oligohydramnios has been associated with limb contractures, craniofacial deformities and pulmonary hypoplasia. Have also been reported cases of prematurity, intrauterine growth retardation, and patent ductus arteriosus, although it is not clear the relationship to drug exposure.

In contrast, aliskiren experimental studies show no evidence of teratogenic during the first quarter in experimental animals.

Reproductive toxicity studies revealed no effect on rats at oral doses 20 times the maximum human dose or rabbits to 7 times the maximum dose in humans. A dose of 50 mg/kg/day showed a decrease in birth weight in these latter animals.

The manufacturer recommends stopping treatment with this class of drugs as soon as the patient is pregnant. It is only justified the use of these drugs if it is a vital necessity for the pregnant patient.

In these extreme cases, the mother should be advised of the risks inherent to the drug and should undergo serial ultrasound scans to assess, at least, the state of the amniotic fluid to detect the presence of oligohydramnios.

Both the pregnant woman and the physician should be aware that oligohydramnios may not appear until later stages that fetal injuries have reached a level severe and irreversible.

Update 01.08.2009

Meaning of category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.