Safety
?
-
Benicar (olmesartan medoxomil) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2012
PRECAUTIONS
Drug Interactions
Drug Interactions with Olmesartan Medoxomil
- Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent Colesevelam Hydrochloride reduces the systemic exposure and peak plasma concentration of Olmesartan…
March 2012
BOXED WARNING
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Benicar 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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Benicar as soon as possible.
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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Benicar as soon as possible. These…
Pediatric Use
- Neonates with a history of in utero exposure to Benicar:
- 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.
PATIENT COUNSELING INFORMATION
- Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Benicar 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.
February 2012
BOXED WARNING
WARNING—AVOID USE IN PREGNANCY
WARNINGS AND PRECAUTIONS
Morbidity in Infants
- Children <1 year of age must not receive Benicar for hypertension. Drugs that act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the development of immature kidneys.
USE IN SPECIFIC POPULATIONS
Pediatric Use
- Benicar has not been shown to be effective for hypertension in children <6 years of age.
- Children <1 year of age must not receive Benicar for hypertension. The renin-angiotensin aldosterone system (RAAS) plays a critical role in kidney development. RAAS blockade has been shown to lead to abnormal kidney development in very young mice. Administering drugs that act directly on the renin- angiotensin aldosterone system (RAAS) can alter normal renal development.
June 2011
*NSAID interaction
DRUG INTERACTIONS
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitor(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 angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.
- The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.
May 2011
ADVERSE REACTIONS
Postmarketing Experience
- Anaphylactic reactions
-
-
