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.

VANTAS (NDA-021732)

(HISTRELIN ACETATE)

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

Download Data

Expand all

05/06/2026 (SUPPL-26)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post approval use of VANTAS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

. . .

Psychiatric Disorders: suicidal ideation and attempt.

09/23/2025 (SUPPL-25)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Severe Cutaneous Adverse Reactions

Newly added subsection:

VANTAS can cause severe cutaneous adverse reactions (SCARs) , including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). SCARs, including SJS/TEN, DRESS, and AGEP, occurred in patients receiving VANTAS or other GnRH agonists; including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions (6.2)].

Monitor patients for the development of SCARs.

If a SCAR is suspected, interrupt VANTAS until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other grade 4 skin reactions, permanently discontinue VANTAS.

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)]

…

6.2 Postmarketing Experience

…

Skin Reactions: erythema multiforme, bullous dermatitis, dermatitis exfoliative, DRESS, SJS/TEN, and AGEP.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Severe Cutaneous Adverse Reactions

Inform patients and/or caregivers that severe cutaneous adverse reactions (SCARs), including SJS/TEN, DRESS, and AGEP, which may be life threatening or fatal, may occur during treatment with VANTAS. Advise patients and/or caregivers to contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs, e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy [see Warnings and Precautions (5.6)].

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What are the possible side effects of VANTAS?

VANTAS may cause serious side effects, including:

…

Severe skin reactions. VANTAS may cause severe skin reactions that can be life-threatening and can lead to death. Call your healthcare provider or get medical help right away if you get any signs or symptoms of severe skin reactions, including:
- Fever
- painful sores or ulcers in mouth or nose, throat, or genital area
- flu-like symptoms
- swollen or painful lymph nodes
- skin rash, including red pus-filled spots on the skin, or rash that keeps getting worse
- skin pain, burning, or peeling
- blistering of the skin, lips, eyes or mouth
Changes in the electrical activity of your heart (QT prolongation). Your healthcare provider may check the electrical activity of your heart with an electrogram (ECG) and the levels of body salts in your blood (electrolytes) during treatment with VANTAS.
…

12/16/2020 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.8 Embryo-Fetal Toxicity

(Newly added subsection)

The safety and efficacy of VANTAS have not been established in females. Based on findings from animal studies and its mechanism of action, VANTAS can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. In animal reproduction studies, administration of VANTAS to pregnant rats and rabbits during the period of organogenesis caused an increase in fetal loss at clinically relevant exposures. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus [see Use in Specific Populations (8.1)].

6 Adverse Reactions

6.1 Clinical Trials Experience

(Subsection title revised)

6.2 Postmarketing Experience

(Subsection title revised)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

The safety and efficacy of VANTAS have not been established in females. Based on findings in animal studies and its mechanism of action, VANTAS can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Expected hormonal changes that occur with VANTAS treatment increase the risk for pregnancy loss. The limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. In animal reproduction studies, administration of histrelin to pregnant rats and rabbits during the period of organogenesis caused an increase in fetal loss at clinically relevant exposures (see Data). Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Data

Animal Data

Histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and post-implantation loss at doses of 1, 3, 5 or 15 mcg/kg/day (approximately 0.2- to 3-times clinical exposure based on body surface area). These dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. Histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 8- to 31-times clinical exposures based on body surface area).

8.2 Lactation

(PLLR conversion)

The safety and efficacy of VANTAS have not been established in females. There are no data on the presence of VANTAS in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VANTAS and any potential adverse effects on the breastfed child from VANTAS or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

(PLLR conversion)

Infertility Male

Based on findings in animals and mechanism of action, VANTAS may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of VANTAS in pediatric patients have not been established.

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

PATIENT COUNSELING INFORMATION

(Extensive revision; please refer to label)

PATIENT INFORMATION

(Extensive revision; please refer to label)

02/11/2019 (SUPPL-22)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Effect on QT/QTc Interval

(Newly Added Subsection)

Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.