• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Aceon (perindopril erbumine) tablets

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

 

February 2013

Summary View

 

CONTRAINDICATIONS

  • Do not co-administer aliskiren with Aceon in patients with diabetes
 

DRUG INTERACTIONS

Dual Blockade of the Renin-Angiotensin System (RAS)
  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on Aceon and other agents that affect the RAS.
  • Do not co-administer aliskiren with Aceon in patients with diabetes. Avoid use of aliskiren with Aceon in patients with renal impairment (GFR <60 ml/min).

 

April 2012

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue ACEON as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
 

WARNINGS AND PRECAUTIONS

Fetal toxicity
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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations…
 

USE IN SPECIAL POPULATIONS

Pregnancy
  • 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations…
 
Pediatric Use
  • Neonates with a history of in utero exposure to ACEON: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion…
 

PATIENT COUNSELING INFORMATION

  • Female patients of childbearing age should be told about the consequences of exposure to ACEON during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible… 

 

August 2011 

Summary View

 

DRUG INTERACTIONS

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase -2 Inhibitors (COX- 2 Inhibitors
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including perindopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving perindopril and NSAID therapy. The antihypertensive effect of ACE inhibitors, including perindopril, may be attenuated by NSAIDs, including selective COX-2 inhibitors.

 

December 2010

Summary View

 

Boxed Warning (Language revised)

WARNING: AVOID USE IN PREGNANCY
  • When pregnancy is detected, discontinue Aceon as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.

CONTRAINDICATIONS

  • Aceon is also contraindicated in patients with hereditary or idiopathic angioedema

ADVERSE REACTIONS

  • Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.