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U.S. Department of Health and Human Services

Safety

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Atacand (Candesartan Cilexetil)

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

Summary View

 

BOXED WARNING

  • WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue ATACAND 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…
 

USE IN SPECIFIC POPULATIONS

Pregnancy
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…
Pediatric Use
  • Neonates with a history of in utero exposure to Atacand: 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.

 

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