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U.S. Department of Health and Human Services

Safety

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Prinivil (lisinopril) tablets and Prinzide (lisinopril/hydrochlorothiazide) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012

 

Summary View

 

*fetal toxicity
 

BOXED WARNING

  • WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Prinivil/Prinzide as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

 

WARNINGS

Fetal Toxicity (Previously Fetal/Neonatal Morbidity and Mortality)
Pregnancy category D
  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death…
  • When pregnancy is detected, discontinue Prinivil/Prinzide as soon as possible. These adverse outcomes are usually associated with the use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the reninangiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

 

PRECAUTIONS

Pregnancy
  • Discuss treatment options with women planning to become pregnant.
Pediatric Use
  • Neonates with a history of in utero exposure to Prinivil/Prinzide : If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
  • Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Lisinopril, which crosses the placenta, has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure.