Label Changes for:

Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets

January 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) – January 2012

 

  • Accupril (quinapril hydrochloride) 5 mg, 10 mg 20 mg, 40 mg Tablets
  • Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets
  • Altace (ramipril) 1.25, 2.5, 5, and 10 mg Tablets
  • Avalide (irbesartan/hydrochlorothiazide) Tablets, 150/12.5 mg and 300/12.5 mg
  • Avapro (irbesartan) 75 mg, 150 mg, and 300 mg Tablets
  • Azor (amlodipine/olmesartan) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
  • Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets
  • Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets
  • Diovan HCT (valsartan/hydrochlorothiazide) 80/12.5 mg, 160/12.5 mg,160/25 mg, 320/12.5 mg, and 320/25 mg Tablets
  • Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
  • Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets
  • Lotensin (benazepril) 5 mg, 10 mg, 20 mg, and 40 mg Tablets
  • Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg, 20/12.5 mg, and 25/25/mg Tablets
  • Lotrel (amlodipine besylate and benazepril hydrochloride) 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
  • Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets
  • Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets
  • Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets
  • Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg 2/240 mg and 4/240 mg Tablets
  • Teveten (eprosartan mesylate) 400 mg and 600 mg Tablets
  • Teveten HCT (eprosartan mesylate/hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets
  • Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 and 40/10/25 mg Tablets 
  • Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets
  • Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets

 

Old Label Format:

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue [xxx] 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 fetal renal function and increases fetal and neonatal morbidity and death......

PRECAUTIONS

Information for Patients
  • Female patients of childbearing age should be told about the consequences of exposure.....
Pediatric Use 
  • Neonates with a history of in utero exposure to [xxx]:
    • If oliguria or hypotension occurs, direct attention toward support..... 

 

New Label Format (PLR):

 

BOXED WARNING

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning

  • When pregnancy is detected, discontinue [xxx] as soon as possible (5.x)
  • Drugs that act directly on the renin-angiotensin system can cause injury and  death to the developing fetus (5.x)

5 WARNINGS AND PRECAUTIONS

5.x Fetal Toxicity

Pregnancy Category D

  • Use of drugs that act on the renin-angiotensin system during the second and trimesters of pregnancy reduces.....

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Pregnancy Category D

  • Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.....
8.4 Pediatric Use [new section]

Neonates with a history of in utero exposure to [xxx]:

  • If oliguria or hypotension occurs, direct attention toward support....

17 PATIENT COUNSELING INFORMATION

Information for Patients
  • Female patients of childbearing age should be told about the consequences of exposure to [xxx] during pregnancy. Discuss treatment options....

PATIENT PACKAGE INSERT

What is the most important information I should know about [xxx]?
  • [xxx] 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 [xxx], tell your doctor right away.
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