Drug Safety-related Labeling Changes (SrLC)

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VASERETIC (NDA-019221)

(ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE)

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

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08/20/2020 (SUPPL-50)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Information for Patients:

Newly added information:

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

6 Adverse Reactions

Postmarketing Experience

Newly added information:

Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of greater than or equal to 50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

07/21/2017 (SUPPL-47)

Approved Drug Label (PDF)

4 Contraindications

Addition of the following:

… VASERETIC is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer VASERETIC within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor …

5 Warnings and Precautions

PRECAUTIONS

Drug Interactions

Addition of the following:

Neprilysin Inhibitors

Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema.

WARNINGS

Head and Neck Angioedema:

Additions and/or revisions underlined:

Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

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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