Label Changes for:

Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets

February 2012

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

 

February 2012

 

Tekturna and Tekturna HCT

*Fetal Toxicity

 

BOXED WARNING

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.
 
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