Label Changes for:

Valturna (aliskiren/valsartan) tablets

February 2012

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) - February and May 2011, and February 2012

 

February 2012

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue Valturna 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
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