Obsessive-Compulsive Disorder (OCD) Treatments
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Paroxetine
What is Brisdelle (Paroxetine)?
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- Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome
- Taking thioridazine because of risk of QT prolongation
- Taking pimozide because of risk of QT prolongation
- With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in BRISDELLE
- Who are or become pregnant because menopausal VMS does not occur during pregnancy and BRISDELLE may cause fetal harm
- Suicidality
- Serotonin syndrome
- Abnormal bleeding
- Angle-Closure Glaucoma
- Hyponatremia
- Bone Fracture
- Mania/Hypomania
- Seizure
- Seizures, which may be delayed, and altered mental status including coma.
- Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
- Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk).

- Trial 1 was a 12-week trial with a total of 606 postmenopausal females (average age 55 years; 65% White, 33% Black or African American, and 2% other races; 10.6% were Hispanic/Latina and 89.4% were not Hispanic/Latina; 18% surgically menopausal and 82% naturally menopausal).
- Trial 2 was a 24-week trial with a total of 568 postmenopausal females (average age 54 years; 76% White, 22% Black or African American, and 2% other races; 6.5% were Hispanic/Latina and 93.5% were not Hispanic/Latina; 20% surgically menopausal and 81% naturally menopausal).
- Data from Trial 1 showed a statistically significant reduction from baseline in the frequency of moderate to severe VMS at Week 4 and Week 12 and a statistically significant reduction in the severity of moderate to severe VMS at Week 4 in the BRISDELLE group compared to the placebo group (Table 4).
- Data from Trial 2 showed a statistically significant reduction from baseline in the frequency and severity of moderate to severe VMS at Week 4 and Week 12 in the BRISDELLE group compared to placebo group (Table 5).


