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Drug Safety-related Labeling Changes (SrLC)

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PAXIL (NDA-020031)

(PAROXETINE HYDROCHLORIDE)

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

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11/26/2024 (SUPPL-83)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Embryofetal Toxicity

Additions and revisions underlined:

Based on meta-analyses of epidemiological studies, exposure to paroxetine in the first trimester of pregnancy is associated with a less than 2-fold increase in the rate of cardiovascular malformations among infants. For women who intend to become pregnant or who are in their first trimester of pregnancy, PAXIL, should be initiated only after consideration of the other available treatment options [see Use in Specific Populations (8.1)].


8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion; please refer to label


8.2 Lactation

Newly added subsection:

Risk Summary

Data from the published literature report the presence of paroxetine in human milk (see Data). There are reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to paroxetine through breast milk (see Clinical Considerations). There are no data on the effect of paroxetine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Paxil and any potential adverse effects on the breastfed child from Paxil or from underlying maternal condition.

Clinical Considerations

Infants exposed to PAXIL should be monitored for agitation, irritability, poor feeding and poor weight gain.

Data

Published literature suggests the presence of paroxetine in human milk with relative infant doses ranging between 0.4% to 2.2%, and a milk/plasma ratio of <1. No significant amounts were detected in the plasma of infants after breastfeeding.


8.3 Females and Males of Reproductive Potential

Newly added subsection:

Infertility

Male

Based on findings from clinical studies, paroxetine may affect sperm quality which may impair fertility; it is not known if this effect is reversible [see Nonclinical Toxicology (13.1)].


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

Medication Guide

Newly added information:

o Taking PAXIL during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth.

o Taking PAXIL during your third trimester of pregnancy may cause your baby to have breathing, temperature, and feeding problems, low muscle tone, and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth.

o There is a pregnancy registry for females who are exposed to PAXIL during pregnancy. The purpose of the registry is to collect information about the health of females exposed to PAXIL and their baby. If you become pregnant during treatment with PAXIL talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/


08/18/2023 (SUPPL-82)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Serotonin Syndrome

Additions and revisions underlined:

SSRIs, including PAXIL, 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, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7.1)].

5.5 Increased Risk of Bleeding

Newly added information:

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)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and revisions underlined:

The following reactions have been identified during post approval use of PAXIL. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), syndrome of inappropriate ADH secretion, prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, oculogyric crisis which has been associated with concomitant use of pimozide; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anosmia, hyposmia, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women.

7 Drug Interactions

Drug Interactions

Addition of opioids and amphetamines to table 9

8 Use in Specific Populations

8.1 Pregnancy

Newly added information:

Risk Summary

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 (5.5) and Clinical Considerations].

Maternal Adverse Reactions

Use of PAXIL in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.5)].

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

Medication Guide

Additions and revisions underlined:

Especially tell your healthcare provider if you take:

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

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of PAXIL with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, 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).

09/20/2021 (SUPPL-79)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.13 Sexual Dysfunction

(Newly added subsection)

Use of SSRIs, including PAXIL, 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 PAXIL 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.

6 Adverse Reactions

(Addition of the following to the bulleted line listing)

  • Sexual Dysfunction [see Warnings and Precautions (5.13)]

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 PAXIL, 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 PAXIL. There may be treatments your healthcare provider can suggest.

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Sexual Dysfunction

Advise patients that use of PAXIL 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 (5.13)].

02/06/2021 (SUPPL-77)

Approved Drug Label (PDF)

Boxed Warning

(Extensive changes; please refer to label)

Other

(PLR conversion. Please refer to label for complete information.)

01/04/2017 (SUPPL-74)

Approved Drug Label (PDF)

5 Warnings and Precautions

Serotonin Syndrome:

Additions and/or revisions underlined:

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including PAXIL 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 PAXIL with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines and St. John’s Wort is clinically warranted …

7 Drug Interactions

Additions and/or revisions underlined:

Serotonergic Drugs: Based on the mechanism of action of paroxetine and the potential for serotonin syndrome, caution is advised when paroxetine is coadministered with other drugs or agents that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, fentanyl, tramadol, amphetamines, or St. John’s Wort.