Label Changes for:
Atacand HCT (candesartan cilextetil/hydrochlorothiazide) Tablets
Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2012
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Atacand HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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 Atacand HCT as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy…
Information for patients:
- Female patients of childbearing age should be told about the consequences of exposure to Atacand HCT during pregnancy. Discuss treatment options with women planning to become pregnant.
Neonates with a history of in utero exposure to Atacand HCT
- 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…