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.

PATANASE (NDA-021861)

(OLOPATADINE HYDROCHLORIDE)

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

Download Data

Expand all

03/04/2021 (SUPPL-15)

Approved Drug Label (PDF)

6 Adverse Reactions

Additions underlined

The most clinically significant adverse reactions described in other sections of labeling include:

Epistaxis, Nasal Ulceration, and Nasal Septal Perforation [see Warnings and Precautions (5.1)]
Somnolence and Impaired Mental Alertness [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Additions underlined

…

The safety data described below reflect exposure to PATANASE in 2770 patients with seasonal or perennial allergic rhinitis in 10 controlled clinical trials of 2 weeks to 12 months duration. PATANASE is not indicated for use in patients with perennial allergic rhinitis.

…

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion

Risk Summary

Published data from postmarketing experience with antihistamines, with similar mechanism of action to PATANASE, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

However, there are no published human data specific to PATANASE. In animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 110 and 1460 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m2 basis, respectively (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively.

Data

Animal Data

In an oral embryo-fetal development study, pregnant rabbits were dosed throughout the period of organogenesis at doses up to 400 mg/kg/day. A decrease in the number of live fetuses was observed at 400 mg/kg/day (1460 times the MRHDID, on a mg/m2 basis).

In an oral embryo-fetal development study, pregnant rats were dosed throughout the period of organogenesis at doses up to 600 mg/kg/day. Maternal toxicity, producing death and reduced maternal body weight gain was observed at 600 mg/kg/day (approximately 1100 times the MRHDID on a mg/m2 basis). Olopatadine produced cleft palate at 60 mg/kg/day (approximately 110 times the MRHDID on a mg/m2 basis) and decreased embryo-fetal viability and reduced fetal weight in rats at 600 mg/kg/day (approximately 1100 times the MRHDID on a mg/m2 basis).

In peri-/postnatal toxicity studies, pregnant rats received oral doses of olopatadine up to 600 mg/kg/day during late gestation and throughout the lactation period. Olopatadine produced decreased neonatal survival at 60 mg/kg/day (approximately 110 times the MRHDID on a mg/m2 basis) and reduced body weight gain in pups at 4 mg/kg/day (approximately 7 times the MRHDID on a mg/m2 basis). These effects appeared attributable to exposure of pups via the milk as demonstrated in a cross-fostered study in which pups of untreated dams cross-fostered to dams treated with 60 mg/kg/day olopatadine orally during the lactation period exhibited decreased body weight gain.

8.2 Lactation

PLLR conversion

Risk Summary

There are no data on the presence of olopatadine in human milk, the effects on the breastfed infant, or the effects on milk production. Although orally administered olopatadine is present in rat milk, there is no information about nasally administered olopatadine.

It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PATANASE and any potential adverse effects on the breast fed infant from PATANASE or from the underlying maternal condition.

8.4 Pediatric Use

Additions and/or revisions underlined

The safety and effectiveness of PATANASE for the relief of symptoms of seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older.

The safety and effectiveness of PATANASE in pediatric patients 6 to 11 years of age are supported by 3 vehicle- controlled 2-week studies in 870 patients [see Adverse Reactions (6.1)].

…

The safety and effectiveness of PATANASE in pediatric patients aged 12 years and older are supported by 3 randomized, double blind, parallel group, multicenter, placebo-controlled clinical trials of 2 weeks duration in adult and adolescent patients [see Clinical Studies (14)]. In these studies, the incidence of epistaxis with PATANASE use in 587 patients was 3.2% [see Adverse Reactions (6.1)].

The safety and effectiveness of PATANASE have not been established in pediatric patients under 6 years of age.

The safety of PATANASE at a dose of one spray per nostril twice daily was evaluated in one 2-week vehicle-controlled study in 132 pediatric patients 2 to 5 years of age with allergic rhinitis. In this trial, 66 patients were exposed to PATANASE. The most common (greater than 1.0%) adverse reactions reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3.0%), and wheezing (3.0%). Diarrhea was reported more frequently (9.1%) in patients 2 to 5 years of age than 6 to 11year old age group (< 1%).

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

PATIENT COUNSELING INFORMATION

Additions underlined

…

Somnolence and Impaired Mental Alertness

Somnolence has been reported in some patients taking PATANASE. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as driving or operating machinery after administration of PATANASE [see Warnings and Precautions (5.2)].

…

PATIENT INFORMATION

Additions to align with updates in the labeling, please refer to label for complete information.