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.

BRISDELLE (NDA-204516)

(PAROXETINE MESYLATE)

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

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08/18/2023 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Serotonin Syndrome

Additions and/or revisions underlined:

BRISDELLE can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., monoamine oxidase inhibitors (MAOIs) [see Contraindications (4), Drug Interactions (7.3)]. Serotonin syndrome can also occur when these drug are used alone.

…

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Nervous System Disorders: Neuroleptic malignant syndrome, Paresthesia, Somnolence, Tremor, Anosmia, Hyposmia.

…

7 Drug Interactions

7.3 Other Potentially Significant Drug Interactions

Additions and/or revisions underlined:

…

Serotonergic Drugs

If concomitant use of BRISDELLE with other serotonergic drugs (e.g., other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation [see Warnings and Precautions (5.2)]. An interaction between paroxetine and tryptophan may occur when they are co-administered. Adverse experiences, consisting primarily of headache, nausea, sweating, and dizziness, have been reported when tryptophan was administered to patients taking paroxetine. Consequently, concomitant use of BRISDELLE with tryptophan is not recommended.

…

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of BRISDELLE with triptans, tricyclic antidepressants, opioids, linezolid, tramadol, amphetamines, St. John’s Wort, lithium, tryptophan supplements, other serotonergic agents, or antipsychotic drugs [see Warnings and Precautions (5.2) and Drug Interactions (7.3)]. Instruct patients to contact their health care provider, or report to the emergency room, should they experience signs or symptoms of serotonin syndrome.
…
MEDICATION GUIDE
Additions and/or revisions underlined:
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRISDELLE and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.
…
Especially tell your healthcare provider if you take:
…

tramadol, fentanyl, meperidine, methadone, or other opioids
…

09/20/2021 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.12 Sexual Dysfunction

(Newly added subsection)

Use of SSRIs, including BRISDELLE, may cause symptoms of sexual dysfunction. In female patients, SSRI/SNRI use may result in decreased libido and delayed or absent orgasm.

It is important for prescribers to inquire about sexual function prior to initiation of BRISDELLE and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

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

MEDICATION GUIDE

(Additions and/or revisions underlined)

…

Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including BRISDELLE, may cause symptoms of sexual problems.

Symptoms in females may include:

Decrease sexual drive
Delayed or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with BRISDELLE. There may be treatments your healthcare provider can suggest.

…

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

…

Advise patients that use of BRISDELLE may cause symptoms of sexual dysfunction in female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.12)].

04/28/2017 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

(Additions and/or revisions are underlined)

The following serious adverse reactions are discussed elsewhere in labeling:

Suicidality
Serotonin syndrome
Abnormal bleeding
Angle-Closure Glaucoma
Hyponatremia
Bone Fracture
Mania/Hypomania
Seizure
Akathisia

01/04/2017 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Serotonin Syndrome

(Additions and/or revisions are underlined)

The development of a potentially life-threatening serotonin syndrome has been reported with SSRIs, including paroxetine, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort)…

If concomitant use of BRISDELLE with other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation.

7 Drug Interactions

7.3 Other Potentially Significant Drug Interactions

(Additions and/or revisions are underlined)

Serotonergic Drugs

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of BRISDELLE with triptans, tricyclic antidepressants, linezolid, tramadol, amphetamines, St. John’s Wort, lithium, tryptophan supplements, other serotonergic agents, or antipsychotic drugs

MEDICATION GUIDE

(Additions and/or revisions are underlined)

Especially tell your healthcare provider if you take:

amphetamines

General information about the safe and effective use of BRISDELLE.

For more information about BRISDELLE call 1-844-732-3521…

Distributed by: Sebela Pharmaceuticals Inc., 645 Hembree Parkway, Suite I, Roswell, Georgia 30076. www.sebelapharma.com

Toll Free 1-844-732-3521