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warnings and cautions
5 WARNINGS AND PRECAUTIONS Suicidality: Monitor for suicidality or unusual changes in behavior ( 5.1 ) Serotonin Syndrome: BRISDELLE can cause serotonin syndrome with increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue BRISDELLE and serotonergic agents and initiate supportive measures ( 5.2 , 7.3 ). Tamoxifen: Efficacy of tamoxifen may be reduced when administered concomitantly with BRISDELLE ( 5.3 , 7.1 ) Abnormal Bleeding: Caution patients about the risk of bleeding associated with the concomitant use of BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation ( 5.4 , 7.1 ) Angle-Closure Glaucoma: Angle closure glaucoma has occurred in patients who have untreated anatomically narrow angles and who are treated with antidepressants. ( 5.5 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH) ( 5.6 ) Bone Fracture: Epidemiological studies have reported an association between SSRI treatment and fractures ( 5.7 ) Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/ hypomania ( 5.8 ) Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold ( 5.9 ) Sexual Dysfunction: BRISDELLE use may cause symptoms of sexual dysfunction. ( 5.12 ) 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults SSRIs increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term trials for the treatment of major depressive disorder (MDD) and other psychiatric disorders - BRISDELLE is not approved for use in any psychiatric condition or in pediatric and young adult patients [see Indications and Usage ( 1 ) and Use in Specific Populations ( 8.4 )] . There is limited information regarding suicidal thoughts and behaviors in females who use BRISDELLE for treatment of moderate to severe VMS associated with menopause. The BRISDELLE trials excluded females with a presence or history of previous psychiatric disorders. Monitor all BRISDELLE-treated patients for any emergence of suicidal thoughts and behaviors, especially during the initial few months of BRISDELLE therapy. Counsel family members to monitor for changes in behavior and to alert the health care provider if such changes occur. Consider discontinuing BRISDELLE in patients who experience emergent suicidal thoughts or behaviors or symptoms that might be precursors to suicidal thoughts or behaviors, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. 5.2 Serotonin Syndrome 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 BRISDELLE is used alone. Serotonin syndrome 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), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The concomitant use of BRISDELLE with MAOIs is contraindicated. Do not start BRISDELLE in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dosage range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral or local tissue injection) or at lower dosages. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking BRISDELLE, The patient should be taken off BRISDELLE before initiating treatment with the MAOI [see Contraindications ( 4.1 )] . If concomitant use of BRISDELLE with other serotonergic drugs (besides MAOIs) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during BRISDELLE initiation [see Contraindications ( 4.1 ) Drug Interactions ( 7.3 )] . Monitor all patients taking BRISDELLE for the emergence of serotonin syndrome. Discontinue BRISDELLE and any concomitant serotonergic agents immediately if the above events occur and initiate supportive symptomatic treatment. 5.3 Potential Impact on Tamoxifen Efficacy Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when concomitantly administered with paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6 and lower tamoxifen blood levels [see Drug Interactions ( 7.1 )] . However, other studies have failed to demonstrate such a risk. When tamoxifen is used for the treatment or prevention of breast cancer, weigh the likely benefit of BRISDELLE for treating moderate to severe VMS associated with menopause vs. the risk of possible decreased tamoxifen effectiveness, and consider avoiding the concomitant use of BRISDELLE. 5.4 Increased Risk of Bleeding SSRIs, including BRISDELLE, increased the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk [see Drug Interactions ( 7.3 )] . 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 SSRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Inform patients about the risk of bleeding associated with the concomitant use of BRISDELLE and antiplatelet agents or anticoagulants [see Drug Interactions ( 7.1 )] . For patients taking warfarin, carefully monitor the international normalized ratio. 5.5 Angle-Closure Glaucoma The pupillary dilation that occurs following use of SSRIs, including BRISDELLE, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Cases of angle-closure glaucoma associated with use of paroxetine have been reported. Avoid use of SSRIs, including BRISDELLE, in patients with untreated anatomically narrow angles. 5.6 Hyponatremia Hyponatremia may occur as a result of treatment with SSRIs, including BRISDELLE. Cases with serum sodium lower than 110 mmol/L have been reported in patients using SSRIs. Geriatric patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs [see Use in Specific Populations ( 8.5 )] . Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, the hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In patients with symptomatic hyponatremia, discontinue BRISDELLE and institute appropriate medical intervention. 5.7 Bone Fracture Epidemiological studies on bone fracture risk following exposure to SSRIs have reported an association between SSRI treatment and fractures. It is unknown to what extent fracture risk is directly attributable to SSRI treatment. If a BRISDELLE-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising, consider the possibility of a fragility fracture. 5.8 Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania BRISDELLE is only indicated for the treatment of moderate to severe VMS and is not approved for use in treating either depression or bipolar depression. However, prior to initiating treatment with BRISDELLE, all patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It is generally believed (though not established in controlled trials) that use of an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. 5.9 Seizures In clinical studies of another paroxetine product, seizures occurred in 0.1% of paroxetine-treated patients. Use BRISDELLE cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Discontinue BRISDELLE in any patient who develops seizures. 5.10 Sexual Dysfunction Use of SSRIs, including BRISDELLE, may cause symptoms of sexual 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 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. Discuss potential management strategies to support patients in making informed decisions about treatment.