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U.S. Department of Health and Human Services

Safety

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Hyzaar (losartan potassium hydrochlorothiazide) 50-12.5 mg, 100-12.5 mg, and 100-25 mg Tablets

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

 

January 2014

Summary View

BOXED WARNING

Warning: fetal toxicity
  • When pregnancy is detected, discontinue Hyzaar as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity

WARNINGS

Fetal Toxicity

Pregnancy Category D

  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy  reduces renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be  associated ..... (section extensively revised - see PI)

PRECAUTIONS

  • Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Hyzaar during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
  • Neonates with a history of in utero exposure to Hyzaar: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for  disordered  renalfunction.

PPI

What is the most important information I should know about Hyzaar?

  • Hyzaar can cause harm or death to an unborn baby
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you get pregnant while taking Hyzaar, tell your doctor right away. 

 

June 2009

Summary View

 

ADVERSE REACTIONS

Losartan Potassium
  • General disorders and administration site conditions: Malaise
Hydrochlorothiazide/Post-Marketing Experience
  • Hemic: Thrombocytopenia (reworded)