Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

DIOVAN HCT (NDA-020818)

(HYDROCHLOROTHIAZIDE; VALSARTAN)

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

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08/20/2020 (SUPPL-80)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added information underlined:

… Pathological changes in the parathyroid gland of patients with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. If hypercalcemia occurs, further diagnostic evaluation is necessary.

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.

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

PATIENT COUNSELING INFORMATION

Newly added information:

Non-melanoma Skin Cancer

Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

PATIENT INFORMATION

What are the possible side effects of DIOVAN HCT?

DIOVAN HCT may cause serious side effects including:

Newly added information:

Protect your skin from the sun and undergo regular skin cancer screening, as one of the medicines in DIOVAN HCT may cause non-melanoma skin cancer.

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