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.

LUPRON DEPOT-PED (NDA-020263)

(LEUPROLIDE ACETATE)

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

Download Data

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04/07/2020 (SUPPL-46)

Approved Drug Label (PDF)

6 Adverse Reactions

Postmarketing

(Additions and/or revisions underlined)

Musculoskeletal and Connective Tissue Disorders: tenosynovitis-like symptoms, severe muscle pain

05/19/2017 (SUPPL-42)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Psychiatric Events

(Newly added subsection)

Psychiatric events have been reported in patients taking GnRH agonists, including LUPRON DEPOT-PED. Postmarking reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with LUPRON DEPOT-PED.

5.3 Convulsions

(Additions and/or revisions are underlined)

Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate…

6 Adverse Reactions

6.1 LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration - Clinical Trials Experience

(Additions and/or revisions are underlined)

Table 2. Percentage of Patients with Treatment-Emergent Adverse Reactions Occurring in greater than or equal to 2% of Pediatric Patients Receiving LUPRON DEPOT-PED 1-month

Psychiatric System

Less Common Adverse Reactions

The following treatment-emergent adverse reactions were reported in less than 2% of the patients and are listed below by body system.

Body as a Whole…Nervous System – hyperkinesia, somnolence; Psychiatric System – depression, nervousness…

6.3 Postmarketing

(Additions and/or revisions are underlined)

Psychiatric Disorders: Emotional lability, such as crying, irritability, impatience, anger, and aggression has been observed with GnRH agonists, including LUPRON DEPOT-PED; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including LUPRON DEPOT-PED, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Information for Caregivers

• Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression, have been observed in patients receiving GnRH agonists, including LUPRON DEPOT-PED. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with LUPRON DEPOT-PED.

• Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk.

• The caregivers should notify the physician if new or worsened symptoms develop after beginning treatment.

MEDICATION GUIDE LUPRON DEPOT-PED® (loo-pron depo peed) (leuprolide acetate for depot suspension)

(Medication Guide added; please refer to label)