Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

VASOSTRICT (NDA-204485)

(VASOPRESSIN)

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

Download Data

Expand all

03/26/2021 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Worsening Cardiac Function

(Additions and/or revisions underlined)

A decrease in cardiac index may be observed with the use of vasopressin.

7 Drug Interactions

7.1 Catecholamines

(Additions and/or revisions underlined)

Use with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

7.2 Indomethacin

(Additions and/or revisions underlined)

Use with indomethacin may prolong the effect of Vasostrict® on cardiac index and systemic vascular resistance. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [see Clinical Pharmacology (12.3)].

7.3 Ganglionic Blocking Agents

(Additions and/or revisions underlined)

Use with ganglionic blocking agents may increase the effect of Vasostrict® on mean arterial blood pressure. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. [see Clinical Pharmacology (12.3)].

7.4 Drugs Suspected of Causing SIADH

(Additions and/or revisions underlined)

Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine, vincristine, cyclophosphamide, ifosfamide, felbamate) may increase the pressor effect in addition to the antidiuretic effect of Vasostrict®. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

8 Use in Specific Populations

8.2 Lactation

(PLLR conversion. Please refer to label for complete information.)

There are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

Pregnancy

(PLLR conversion)

(Additions and/or revisions underlined)

Risk Summary

There are no available data on Vasostrict® use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted.

Clinical Considerations

Dose adjustments during pregnancy and the postpartum period: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasostrict® may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Maternal adverse reactions: Vasostrict® may produce tonic uterine contractions that could threaten the continuation of pregnancy.

02/21/2020 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Reversible Diabetes Insipidus

(new subsection added)

Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts.

6 Adverse Reactions

(additions underlined)

…

Postmarketing Experience

Reversible diabetes insipidus.

7 Drug Interactions

7.6 Drugs Suspected of Causing Diabetes Insipidus

(additions underlined)

… Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.

05/14/2019 (SUPPL-9)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Vasostrict® 10 mL multiple dose vial is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. The 1 mL single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin.