Drug Safety-related Labeling Changes (SrLC)

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DIOVAN HCT (NDA-020818)

(HYDROCHLOROTHIAZIDE; VALSARTAN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/12/2019 (SUPPL-75)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Fetal Toxicity

Additions and/or revisions underlined:

Diovan HCT can cause fetal harm when administered to a pregnant woman.  Use of drugs that act …

Thiazides cross the placenta and use of thiazides during pregnancy is associated with fetal

When pregnancy is detected, discontinue Diovan HCT as soon as possible.

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added information:

Musculoskeletal: Rhabdomyolysis

7 Drug Interactions

Additions and/or revisions underlined:

Valsartan:

Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements … and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.

8 Use in Specific Populations

PLLR conversion for subsections below; please refer to label for complete information:

8.1 Pregnancy

8.2 Lactation

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Lactation: Advise women not to breastfeed during treatment with Diovan HCT.

PATIENT INFORMATION

What should I tell my doctor before taking DIOVAN HCT?

Tell your doctor about all of your medical conditions, including if you:

  • are breastfeeding. It is not known if DIOVAN HCT effects your breastfed baby or milk production. Do not breastfeed while you are taking DIOVAN HCT.

Tell your doctor about all the medicines you take including prescription … causing serious side effects. Especially, tell your doctor if you take:

  • aspirin or other medicines called non-steroidal anti-inflammatory Drugs (NSAIDs), like ibuprofen or naproxen

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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