Skip to Content

Aliskiren Pregnancy and Breastfeeding Warnings

Aliskiren is also known as: Tekturna

Aliskiren Pregnancy Warnings

When administered during the second or third trimester of pregnancy, drugs that act directly on the renin-angiotensin-aldosterone system can cause fetal and neonatal morbidity and death. If the patient becomes pregnant while taking aliskiren, the drug should be discontinued as soon as possible and the patient should be informed of the potential risks to the fetus based on the time of gestational exposure (first trimester only or later). If exposure occurs beyond the first trimester, an ultrasound examination should be performed. In rare cases when another antihypertensive agent cannot be used to treat the pregnant patient, serial ultrasound examinations should be used to assess the intra-amniotic environment. Routine fetal testing with nonstress tests, biophysical profiles, or contraction stress tests may be appropriate based on gestational age and standards of care in the community. If oligohydramnios occurs in these situations, individualized decisions about continuing treatment and about pregnancy management should be made. Oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants exposed to aliskiren in utero should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, these infants may require blood pressure and renal perfusion support. Exchange transfusion or dialysis may be required to reverse hypotension or support decreased renal function. US FDA pregnancy 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.

Use is contraindicated. US FDA pregnancy category: D Comments: -Adequate methods of contraception should be encouraged. -This drug can harm a fetus. -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.

See references

Aliskiren Breastfeeding Warnings

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Frampton JE, Curran MP "Aliskiren: A Review of its Use in the Management of Hypertension." Drugs 67 (2007): 1767-1792
  3. "Product Information. Tekturna (aliskiren)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Tekturna (aliskiren)." Novartis Pharmaceuticals, East Hanover, NJ.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.