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Safety

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Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Fetal/Neonatal Morbidity and Mortality

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Therapy - Hypertension

USE IN SPECIFIC POPULATIONS

  • Pregnancy
    • Pregnancy Category D
  • Nursing Mothers

PATIENT COUNSELING INFORMATION

  • Information for Patients
    • Pregnancy

PATIENT PACKAGE INSERT

  • What is Diovan HCT?
    • Diovan HCT may be used to lower high blood pressure (hypertension) in adults...
      • ...as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than one medicine.
  • What is high blood pressure (hypertension)?
    • ...High blood pressure makes the heart work harder to pump blood throughout the body...

WARNINGS AND PRECAUTIONS

Fetal/Neonatal Morbidity and Mortality

Diovan HCT can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Drugs that act on the renin-angiotensin system can cause fetal and neonatal morbidity and mortality when used in pregnancy. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death [See Use in Specific Populations (8.1)]...
    
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