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U.S. Department of Health and Human Services

Safety

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Aceon (perindopril erbumine) Tablets September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • USE IN PREGNANCY

WARNINGS

  • Fetal/Neonatal Morbidity and Mortality

PRECAUTIONS

  • Information for Patients
    • Pregnancy
  • Drug Interactions
    • Gold (added)
  • Pregnancy
    • Pregnancy Category D. (See WARNINGS: Fetal/Neonatal Morbidity and Mortality.)
  • Geriatric Use
    • ...Perindopril should be used with caution when administered to elderly patients who are at an increased risk for falls due to age...

ADVERSE REACTIONS

  • Potential Adverse Effects Reported with ACE Inhibitors
    • pemphigus, falls, psoriasis (added)

BOXED WARNING

USE IN PREGNANCY

When used in pregnancy, ACE inhibitors can cause injury and even death to the developing fetus...

WARNINGS

Fetal/Neonatal Morbidity and Mortality

...The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation and hypoplastic lung development.

Prematurity, intrauterine growth retardation, patent ductus arteriosus, and other structural cardiac malformations, as well as neurological malformations, have been reported following exposure to ACE inhibitors during the first trimester of pregnancy.

When patients become pregnant, physicians should make every effort to discontinue the use of Aceon Tablets as soon as possible. Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment...

 

Label approved 09/03/2008 is not available on this site