Label Changes for:
Aceon (perindopril erbumine) Tablets
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010 and August 2011
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.
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.
- Aceon is also contraindicated in patients with hereditary or idiopathic angioedema
- 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.