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.

PARNATE (NDA-012342)

(TRANYLCYPROMINE SULFATE)

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

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01/04/2018 (SUPPL-64)

Approved Drug Label (PDF)

Boxed Warning

Physician Labeling Rule (PLR conversion); additions and/or revisions underlined:

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. PARNATE is not approved for use in pediatric patients.

Hypertensive Crisis with Significant Tyramine Use

Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

4 Contraindications

PLR Conversion; Revised as below into subsections.

Table 1: Products Contraindicated with the Use of Parnate added – please refer to label for complete information.

4.1 Combination with Certain Drugs

Concomitant use of PARNATE or use in rapid succession with the products in Table 1 is

contraindicated. Such use may cause severe or life-threatening reactions such as hypertensive crises or serotonin syndrome. Medication-free periods between administration of PARNATE and contraindicated agents are recommended.

Table 1: Products Contraindicated with the Use of PARNATE

4.2 Pheochromocytoma and Catecholamine-Releasing Paragangliomas

PARNATE is contraindicated in the presence of pheochromocytoma or other catecholamine- releasing paragangliomas because such tumors secrete pressor substances and can lead to hypertensive crisis.

5 Warnings and Precautions

PLR conversion: The following subsections and tables were created; please refer to label for complete information.

5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults

Table 2: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients

5.2 Hypertensive Crisis and Hypertension

5.3 Serotonin Syndrome

5.4 Activation of Mania or Hypomania

5.5 Hypotension

5.6 Hypotension and Hypertension during Anesthesia and Perioperative Care

5.7 Need for Emergency Treatment with Contraindicated Drugs

5.8 Discontinuation Syndrome

5.9 Risk of Clinically Significant Adverse Reactions due to Persistence of MAO Inhibition after Discontinuation

5.10 Hepatotoxicity

5.11 Seizures

5.12 Hypoglycemia in Diabetic Patients

5.13 Aggravation of Coexisting Symptoms of Depression

5.14 Adverse Effects on the Ability to Drive and Operate Machinery

6 Adverse Reactions

PLR conversion; entire section has been revised; please refer to label for complete information.

7 Drug Interactions

PLR Conversion; newly added information, along with tables; please refer to label for complete information.

7.1 Clinically-Significant Drug Interactions

Table 3: Clinically Significant Drug Interactions with Drug Classes

Table 4: Clinically Significant Drug Interactions with Individual Products

7.2 Tyramine-Containing Foods and Beverages

Table 5: Food and Beverages with and Without Significant Amounts of Tyramine

8 Use in Specific Populations

PLR conversion: Please refer to label for complete information on newly created subsections:

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

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

MEDICATION GUIDE

PLR conversion; medication guide has been completely revised; please refer to label for complete information.

PATIENT COUNSELING INFORMATION

PLR conversion; newly added section, as below:

Advise the patient to read FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behaviors

Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and when the dosage is adjusted up or down.

Hypertensive Crisis

Advise the patient on possible symptoms and instruct the patient to seek immediate medical attention if related signs or symptoms are present.

Serotonin Syndrome

Advise the patient on possible symptoms, and explain the potentially fatal nature of serotonin syndrome and that it may result from an interaction with other serotonergic drugs. Instruct the patient to seek immediate medical attention if related signs or symptoms are present.

Interaction with Other Drugs and Dietary Supplements

Warn the patient not to take concomitant medications, whether prescription or over-the-counter drugs, or dietary supplements without prior consultation with a health care provider able to provide advice on the potential for interactions.

Explain to the patient that some other drugs may require a medication-free interval even after discontinuation of PARNATE.

Advise the patient to inform other physicians, pharmacists, and dentists about the treatment with PARNATE.

Interaction with Foods and Beverages

Warn the patient to avoid tyramine-rich foods and beverages.

Advise the patient to avoid eating foods if storage conditions or freshness is unknown and to be cautious of foods of unknown age or composition even if refrigerated.

Hypotension

Advise the patient to report any symptoms of hypotension in the initial phase of treatment to the healthcare provider, because occurrence of such symptoms may require discontinuation.

Withdrawal Symptoms

Warn the patient not to stop PARNATE treatment abruptly, as withdrawal symptoms may occur and that the effect of PARNATE may continue even after discontinuation.

Aggravation of Coexisting Symptoms of Depression

Inform the patient that PARNATE may aggravate coexisting symptoms in depression, such as anxiety and agitation and instruct them to contact their healthcare provider if they experience such symptoms.

Effects on Ability to Drive or Use Machinery

Warn the patient about the possible adverse reactions that can impair the performance of potentially hazardous tasks such as driving a car or operating machinery.
Tell the patient not to operate hazardous machinery and automobiles until they are reasonably certain that their ability to engage in such activities is not impaired.