Label Changes for:
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February, June and October 2011, and February 2012
Tekturna and Tekturna HCT
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Tekturna HCT as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.