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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.
LEXAPRO (NDA-021323)
(ESCITALOPRAM OXALATE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
04/19/2024 (SUPPL-58)
8 Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
Before taking Lexapro, tell your healthcare provider about all your medical conditions, including if you or your child:
…
There is a pregnancy registry for females who are exposed to Lexapro during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Lexapro and their baby. If you or your child become pregnant during treatment with Lexapro, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.
08/18/2023 (SUPPL-57)
5 Warnings and Precautions
5.2 Serotonin Syndrome
(Additions and/or revisions underlined)
SSRIs, including Lexapro, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4) and Drug Interactions (7)].
5.7 Increased Risk of Bleeding
(Additions and/or revisions underlined)
Drugs that interfere with serotonin reuptake inhibition, including Lexapro, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the
published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations (8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Inform patients about the increased risk of bleeding associated with the concomitant use of Lexapro and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Drug Interactions (7)].
6 Adverse Reactions
6.2 Post-Marketing Experience
(Additions and/or revisions underlined)
Adverse Reactions Reported Subsequent to the Marketing of Escitalopram
The following adverse reactions have been identified during post-approval use of Lexapro. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: anemia, agranulocytis, aplastic anemia, hemolytic anemia, idiopathic thrombocytopenia purpura, leukopenia, thrombocytopenia.
Cardiac Disorders: atrial fibrillation, bradycardia, cardiac failure, myocardial infarction, tachycardia, torsade de pointes, ventricular arrhythmia, ventricular tachycardia.
Ear and labyrinth disorders: vertigo
Endocrine Disorders: diabetes mellitus, hyperprolactinemia, SIADH.
Eye Disorders: angle closure glaucoma, diplopia, mydriasis, visual disturbance.
Gastrointestinal Disorder: dysphagia, gastrointestinal hemorrhage, gastroesophageal reflux, pancreatitis, rectal hemorrhage.
General Disorders and Administration Site Conditions: abnormal gait, asthenia, edema, fall, feeling abnormal, malaise.
Hepatobiliary Disorders: fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis.
Immune System Disorders: allergic reaction, anaphylaxis.
Investigations: bilirubin increased, decreased weight, electrocardiogram QT prolongation, hepatic enzymes increased, hypercholesterolemia, INR increased, prothrombin decreased.
Metabolism and Nutrition Disorders: hyperglycemia, hypoglycemia, hypokalemia, hyponatremia.
Musculoskeletal and Connective Tissue Disorders: muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis.
Nervous System Disorders: akathisia, amnesia, ataxia, choreoathetosis, cerebrovascular accident, dysarthria, dyskinesia, dystonia, extrapyramidal disorders, grand mal seizures (or convulsions), hypoaesthesia, myoclonus, nystagmus, Parkinsonism, restless legs, seizures, syncope, tardive dyskinesia, tremor.
Pregnancy, Puerperium and Perinatal Conditions: spontaneous abortion.
Psychiatric Disorders: acute psychosis, aggression, agitation, anger, anxiety, apathy, completed suicide, confusion, depersonalization, depression aggravated, delirium, delusion, disorientation, feeling unreal, hallucinations (visual and auditory), mood swings, nervousness, nightmare, panic reaction, paranoia, restlessness, self-harm or thoughts of self-harm, suicide attempt, suicidal ideation, suicidal tendency.
Renal and Urinary Disorders: acute renal failure, dysuria, urinary retention.
Reproductive System and Breast Disorders: menorrhagia, priapism.
Respiratory, Thoracic and Mediastinal Disorders: anosmia, dyspnea, epistaxis, pulmonary embolism, hyposmia, pulmonary hypertension of the newborn.
Skin and Subcutaneous Tissue Disorders: alopecia, angioedema, dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS), ecchymosis, erythema multiforme, photosensitivity reaction, Stevens Johnson Syndrome, toxic epidermal necrolysis, urticaria.
8 Use in Specific Populations
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844- 405-6185 or visiting online at https://womensmentalhealth.org/clnical-and-research-programs/pregnancyregistry/antidepressants/.
Risk Summary
(Additions and/or revisions underlined)
Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7) and Clinical Considerations].
…
Maternal Adverse Reactions
Use of Lexapro in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7)].
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions underlined)
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors
Advise patients, their families and caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the with the concomitant use of Lexapro with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both 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 if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].
05/12/2023 (SUPPL-55)
5 Warnings and Precautions
5.7 Increased Risk of BleedingAdditions and/or revisions underlined:
Drugs that interfere with serotonin reuptake inhibition, including Lexapro, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Inform patients about the increased risk of bleeding associated with the concomitant use of Lexapro and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Drug Interactions (7)].
6 Adverse Reactions
Addition of the following bulleted line listing:
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.1)]
Serotonin syndrome [see Warnings and Precautions (5.2)]
Discontinuation syndrome [see Warnings and Precautions (5.3)]
Seizures [see Warnings and Precautions (5.4)]
Activation of mania or hypomania [see Warnings and Precautions (5.5)]
Hyponatremia [see Warnings and Precautions (5.6)]
Increased Risk of Bleeding [see Warnings and Precautions (5.7)]
Interference with Cognitive and Motor Performance [see Warnings and Precautions (5.8)]
Angle-closure glaucoma [see Warnings and Precautions (5.9)]
Use in Patients with Concomitant Illness [see Warnings and Precautions (5.10)]
Sexual Dysfunction [see Warnings and Precautions (5.11)]
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
Clinical Trial Data Sources
…
Pediatric Patients
Adverse reaction information for pediatric patients was collected in double-blind placebo-controlled studies in 576 pediatric patients 6 to 17 years of age, (286 Lexapro, 290 placebo) with major depressive disorder and in 273 pediatric patients 7 to 17 years of age (137 Lexapro, 136 placebo) with generalized anxiety disorder.
The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD or less than 7 years of age with GAD.
Adverse Reactions Associated with Discontinuation of Treatment Major
Depressive Disorder
…
Pediatric Patients
Adverse reactions in pediatric patients 6 to 17 years of age were associated with discontinuation of 3.5% of 286 patients receiving Lexapro and 1% of 290 patients receiving placebo. The most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was insomnia (1% Lexapro, 0% placebo).
The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD.
Generalized Anxiety Disorder
…
Pediatric Patients
Adverse reactions in pediatric patients 7 to 17 years were associated with discontinuation of 2.9% of 137 patients receiving Lexapro and 1.5% of 136 patients receiving placebo. The most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was activation syndrome (1% Lexapro, 0% placebo), intentional self injury (1% Lexapro, 0% placebo), epistaxis (1% Lexapro, 0% placebo), and nausea (1% Lexapro, 0% placebo).
Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials
Major Depressive Disorder
…
Pediatric Patients
The overall profile of adverse reactions in pediatric patients 6 to 17 years in major depressive disorder was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions (excluding those which appear in Table 2 and those for which the coded terms were uninformative or misleading) were reported at an incidence of at least 2% for Lexapro and greater than placebo: back pain, urinary tract infection, vomiting, and nasal congestion.
The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD.
Generalized Anxiety Disorder
…
Pediatric Patients
Adverse reactions in pediatric patients 7 to 17 years were associated with discontinuation of 2.9% of 137 patients receiving Lexapro and 1.5% of 136 patients receiving placebo. The most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was activation syndrome (1% Lexapro, 0% placebo), intentional self injury (1% Lexapro, 0% placebo), epistaxis (1% Lexapro, 0% placebo), and nausea (1% Lexapro, 0% placebo).
Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials
Major Depressive Disorder
…
Pediatric Patients
The overall profile of adverse reactions in pediatric patients 6 to 17 years in major depressive disorder was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions (excluding those which appear in Table 2 and those for which the coded terms were uninformative or misleading) were reported at an incidence of at least 2% for Lexapro and greater than placebo: back pain, urinary tract infection, vomiting, and nasal congestion.
The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD.
Generalized Anxiety Disorder
…
Pediatric Patients
The overall profile of adverse reactions in pediatric patients 7 to 17 years in generalized anxiety disorder was generally similar to that seen in adult studies, as shown in Table 3. However, the following adverse reactions (excluding those which appear in Table 3) were reported at an incidence of at least 2% for Lexapro and greater than placebo: dizziness (3% Lexapro and 2% placebo), nasopharyngitis (3% Lexapro and 1% placebo), abdominal discomfort (3% Lexapro and 1% placebo), anxiety (3% Lexapro and 1% placebo), irritability (2% Lexapro and 1% placebo), and anger (2% Lexapro and 0% placebo).
…
8 Use in Specific Populations
8.4 Pediatric UseAdditions and/or revisions underlined
Major Depressive Disorder
The safety and effectiveness of Lexapro for the treatment of major depressive disorder have been established in pediatric patients 12 years of age and older. Use of Lexapro for this indication is supported by evidence from adequate and well-controlled studies in adults with additional evidence from an 8-week, flexible-dose, placebo-controlled study that compared Lexapro 10 mg to 20 mg once daily to placebo in pediatric patients 12 to 17 years of age with major depressive disorder [see Clinical Studies (14.1)]. The safety of Lexapro was similar to adult patients with MDD [see Adverse Reactions (6.1)].
The safety and effectiveness of Lexapro for the treatment of major depressive disorder have not been established in pediatric patients younger than 12 years of age. In a 24-week, open- label safety study in 118 pediatric patients aged 7 to 11 years who had major depressive disorder, the safety findings were consistent with the known safety and tolerability profile for Lexapro.
Generalized Anxiety Disorder
The safety and effectiveness of Lexapro for the treatment of generalized anxiety disorder have been established in pediatric patients 7 years of age and older. Use of Lexapro for this indication is supported by evidence from adequate and well-controlled studies in adults with additional evidence from an 8-week, flexible-dose, placebo-controlled study that compared Lexapro 10 mg to 20 mg once daily to placebo in pediatric patients 7 to 17 years of age with GAD [see Clinical Studies (14.2)]. The safety of Lexapro was similar to adult patients with GAD [see Adverse Reactions (6.1)].
The safety and effectiveness of Lexapro for the treatment of generalized anxiety disorder have not been established in pediatric patients younger than 7 years of age.
Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings and Precautions (5.1)]. Decreased appetite and weight loss have been observed in association with the use of SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as Lexapro.
Juvenile Animal Toxicity Data
In a juvenile animal study, male and female rats were administered escitalopram at 5, 40, or 80 mg/kg/day by oral gavage from postnatal day (PND) 21 to PND 69. A delay in sexual maturation was observed in both males and females at ? 40 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 5 mg/kg/day. This NOAEL was associated with plasma AUC levels less than those measured at the maximum recommended dose (MRHD) in pediatrics (20 mg). However, there was no effect on reproductive function. Increased motor activity (both ambulatory and fine movements) was observed in females prior to daily dosing at ? 40 mg/kg/day (3.5 times the MRHD based on AUC levels). A reversible disruption of learning and memory function was observed in males at 80 mg/kg/day with a NOAEL of 40 mg/kg/day, which was associated with an AUC level 3.5 times those measured at the MRHD in pediatrics. There was no effect on learning and memory function in treated female rats.
8.6 Hepatic Impairment
New subsection added:
Increased citalopram exposure occurs in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. The recommended dosage of LEXAPRO in patients with hepatic impairment is 10 mg daily [see Dosage and Administration (2.5)].
8.7 Renal Impairment
New subsection added:
Pharmacokinetics of Lexapro in patients with a creatinine clearance less than 20 mL/minute has not been evaluated. No dosage adjustment is necessary for patients with mild or moderate renal impairment [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
…
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the with the concomitant use of Lexapro with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines and St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both 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 if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)].
Discontinuation Syndrome
Advise patients not to abruptly discontinue Lexapro and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Lexapro is discontinued [see Warnings and Precautions (5.3)].
…
Increased Risk of Bleeding
Inform patients about the concomitant use of Lexapro with NSAIDs, aspirin, warfarin, other antiplatelet drugs, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their healthcare providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.7)].
…
MEDICATION GUIDE
Section was reformatted and revised to align with the expanded patient population, please refer to label for complete information.
09/20/2021 (SUPPL-53)
5 Warnings and Precautions
5.11 Sexual Dysfunction(Newly added subsection)
Use of SSRIs, including Lexapro, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI 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 Lexapro 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)
…
10. Sexual Dysfunction. Taking selective serotonin reuptake inhibitors (SSRIs), including Lexapro, may cause sexual problems.
Symptoms in males may include:
Delayed ejaculation or inability to have an ejaculation
Decreased sex drive
Problems getting or keeping an erection
Symptoms in females may include:
Decreased sex drive
Delayed orgasm 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 Lexapro. There may be treatments your healthcare provider can suggest.
…
(Additions and/or revisions underlined)
…
Sexual Dysfunction
Advise patients that use of Lexapro may cause symptoms of sexual dysfunction in both male and 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 (5.11
...
08/28/2020 (SUPPL-52)
5 Warnings and Precautions
5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults(Additions and/or revisions underlined)
In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. . .
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.
(Additions and/or revisions underlined)
In patients with bipolar disorder, treating a depressive episode with Lexapro or another antidepressant may precipitate a mixed/manic episode. In placebo-controlled trials of Lexapro in major depressive disorder, activation of mania/hypomania was reported in one (0.1%) of 715 patients treated with Lexapro and in none of the 592 patients treated with placebo. One additional case of hypomania has been reported in association with Lexapro treatment. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with racemic citalopram and other marketed drugs effective in the treatment of major depressive disorder. Prior to initiating treatment with Lexapro, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration (2.3)].
Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Lexapro, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors
8 Use in Specific Populations
Lactation(PLLR conversion. Please refer to label for complete information.)
(PLLR conversion. Please refer to label for complete information.)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide(Newly added information)
Taking LEXAPRO late in pregnancy may lead to an increased risk of certain problems in your newborn.
If you become pregnant while taking Lexapro, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or go to https://womensmentalhealth.org/clinical-and- research- programs/pregnancyregistry/antidepressants/.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors
Advise patients, their families and caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].
(Newly added information)
Activation of Mania or Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.5)].
Pregnancy
(Newly added information)
Advise pregnant women to notify their healthcare providers if they become pregnant or intend to become pregnant during treatment with LEXAPRO.
Advise patients that LEXAPRO use later in pregnancy may lead to increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension (PPHN) of the newborn [see Use in Specific Populations (8.1)].
Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LEXAPRO during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise breastfeeding women using LEXAPRO to monitor infants for excess sedation, restlessness, agitation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].
01/11/2019 (SUPPL-51)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE(additions underlined)
Who should not take Lexapro?
…
Do not take Lexapro with Orap® (pimozide) because taking these two drugs together can cause serious heart problems.
…
01/04/2017 (SUPPL-47)
5 Warnings and Precautions
5.2 Serotonin SyndromeAdditions and/or revisions underlined:
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Lexapro, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) …
If concomitant use of Lexapro with other serotonergic drugs including, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamine and St. John’s Wort …
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDEAdditions and/or revisions underlined:
What should I tell my healthcare provider before taking Lexapro? Ask if you are not sure.
Before starting Lexapro, tell your healthcare provider if you:
Are taking certain drugs such as:
Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, amphetamines, or antipsychotics …
Serotonin Syndrome
Additions and/or revisions underlined:
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Lexapro with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines and St. John’s Wort …