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
