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.

GEODON (NDA-020825)

(ZIPRASIDONE HYDROCHLORIDE)

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

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01/22/2025 (SUPPL-65)

Approved Drug Label (PDF)

4 Contraindications

4.3 Monoamine Oxidase Inhibitors (MAOIs)

Newly added section
Ziprasidone is contraindicated in patients taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.4), Drug Interaction (7.3)].

5 Warnings and Precautions

5.4 Serotonin Syndrome

Newly added section:

Ziprasidone can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), 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 (4.3), Adverse Reactions (6.2), Drug Interactions (7.3)].

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of GEODON with MAOIs is contraindicated. In addition, do not initiate GEODON in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking GEODON, discontinue GEODON before initiating treatment with the MAOI [see Contraindications (4.3), Drug Interactions (7.3)].

Monitor all patients taking GEODON for the emergence of serotonin syndrome. Discontinue treatment with GEODON and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of GEODON with other serotonergic drugs is clinically warranted, inform patients of the increased risk of serotonin syndrome and monitor for symptoms.

…

5.15 Hyperprolactinemia

Additions and/or revisions underlined:

…

Published epidemiologic studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer.

…

6 Adverse Reactions

Addition of the following to the bulleted line listing:

The following adverse reactions are described in more detail in other sections of the prescribing information:

Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1)]
Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia- Related Psychosis [see Warnings and Precautions (5.2)]
QT Prolongation and Risk of Sudden Death [see Contraindications (4.2), Warnings and Precautions (5.3)]
Serotonin Syndrome [see Contraindications (4.3), Warnings and Precautions (5.4), Drug Interactions (7.1)]
Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.5)]
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)]
Tardive Dyskinesia [see Warnings and Precautions (5.7)]
Metabolic Changes [see Warnings and Precautions (5.8)]
Rash [see Warnings and Precautions (5.9)]
Orthostatic Hypotension [see Warnings and Precautions (5.10)]
Falls [see Warnings and Precautions (5.11)]
Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.12)]
Seizures [see Warnings and Precautions (5.13)]
Dysphagia [see Warnings and Precautions (5.14)]
Hyperprolactinemia [see Warnings and Precautions (5.15)]
Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.16)]
Priapism [see Warnings and Precautions (5.17)]
Body Temperature Regulation [see Warnings and Precautions (5.18)]

Suicide [see Warnings and Precautions (5.19)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Psychiatric Disorders: Insomnia, mania/hypomania, somnambulism

…

7 Drug Interactions

7.3 Pharmacodynamic Interactions

Newly added information:

…

Risk of serotonin syndrome with concomitant therapy with other serotonergic drugs such as SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort [see Contraindications (4.3), Warnings and Precautions (5.4), Adverse Reactions (6.2)].

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

PATIENT COUNSELING INFORMATION

Newly added information:

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of GEODON with other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair the metabolism of serotonin (in particular, MAOIs, which include those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider, or report to the emergency room, should they experience signs or symptoms of serotonin syndrome [see Contraindication (4.3), Warnings and Precautions (5.4), Drug Interactions (7.3)].

PATIENT INFORMATION

Additions and/or revisions underlined:

Do not take GEODON if you:

…

are taking a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including linezolid or intravenous methylene blue.
have stopped taking an MAOI in the last 14 days.

are allergic to ziprasidone or any of the ingredients in GEODON.

…

Other Important Safety Information

A potentially life-threatening problem called serotonin syndrome can happen when you take GEODON with certain other medicines.

See “Who should NOT take GEODON?”

Call your healthcare provider if you have any of the following signs and symptoms of serotonin syndrome: agitation, hallucinations, coma, or other changes in mental status; racing heartbeat, high or low blood pressure; coordination problems or muscle twitching; nausea, vomiting, or diarrhea; sweating or fever; muscle rigidity.

01/28/2022 (SUPPL-63)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

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

05/18/2021 (SUPPL-62)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Additions underlined

…

Administration Information for Capsules

Advise patients to take GEODON capsules whole. Do not open, crush, or chew the capsules. Instruct patients to take GEODON capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food [see Dosage and Administration (2.1), Drug Interactions (7.10), and Clinical Pharmacology (12.3)].

…

PATIENT INFORMATION

Additions underlined

…

How To Take GEODON

Take GEODON only as directed by your doctor.
Swallow GEODON capsules whole. Do not chew, crush, or open the capsules.

…

01/23/2020 (SUPPL-58)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; please refer to label)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

Limited data from a published case report indicate the presence of ziprasidone in human milk. Although there are no reports of adverse effects on a breastfed infant exposed to ziprasidone via breast milk, there are reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to other atypical antipsychotics through breast milk. There is no information on the effects of ziprasidone on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GEODON and any potential adverse effects on the breastfed child from GEODON or from the mother’s underlying condition.

Clinical Considerations

Infants exposed to GEODON should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements).

8.3 Females and Males of Reproductive Potential

(Newly added subsection)

Infertility

Females

Based on the pharmacologic action of ziprasidone (D2 antagonism), treatment with GEODON may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Severe Cutaneous Adverse Reactions

Pregnancy

Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with GEODON. Advise patients that GEODON may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to GEODON during pregnancy.

Lactation

Advise breastfeeding women using GEODON to monitor infants for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors, and abnormal muscle movements) and to seek medical care if they notice these signs.

Infertility

Advise females of reproductive potential that GEODON may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible.

Patient Information

(Additions and/or revisions underlined)

What To Tell Your Doctor Before You Start GEODON

Only your doctor can decide if GEODON is right for you. Before you start GEODON, be sure to tell your doctor if you:

have had any problem with the way your heart beats or any heart related illness or disease

any family history of heart disease, including recent heart attack
have had any problem with fainting or dizziness
are taking or have recently taken any prescription medicines
are taking any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies
have had any problems with your liver
are pregnant, might be pregnant, or plan to get pregnant

are breastfeeding or plan to breastfeed

Other Important Safety Information

Before taking GEODON, tell your doctor if you

are pregnant or plan on becoming pregnant.

If you become pregnant while receiving GEODON, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/

are breastfeeding or plan to breastfeed. GEODON can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive GEODON.

11/05/2018 (SUPPL-59)

Approved Drug Label (PDF)

Boxed Warning

Text deletions have shortened the section; please refer to label for complete information.

5 Warnings and Precautions

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Additions and/or revisions underlined:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. GEODON is not approved for the treatment of dementia-related psychosis.

5.2 Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis

Newly added subsection:

In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. GEODON is not approved for the treatment of patients with dementia-related psychosis.

02/23/2017 (SUPPL-56)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.9 Falls

(Newly added subsection)

Antipsychotic drugs (which include GEODON) may cause somnolence, postural hypotension, and motor and sensory instability, which could lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.