FDA Approval of Paroxetine for Menopausal Hot Flushes

Orleans, Ronald J.; Li, Li; Kim, Myong‐Jin; Guo, Jia; Sobhan, Mahboob; Soule, Lisa; Joffe, Hylton V.

doi:10.1097/ogx.0000000000000109

Cited by 10 publications

(12 citation statements)

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“…In 2013, the Food and Drug Administration (FDA) approved low‐dose paroxetine (Brisdelle, Noven) for controlling VMS symptoms on the basis of results from two phase three, randomized, placebo‐controlled trials . Nevertheless, the approval was against the recommendation of the FDA's own Reproductive Health Drugs Advisory Committee, which had concluded that the overall benefit–risk profile of paroxetine did not support approval . The FDA's motivation for approval was that there was no other non‐hormonal treatment for VMS and that paroxetine was a useful and relatively safe option for menopausal women.…”

Section: Introductionmentioning

confidence: 99%

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Wei

Chen

et al. 2016

BJOG

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Background Paroxetine is the first non-hormone therapy for vasomotor symptoms (VMS) approved based on the results of two phase 3, randomised, placebo-controlled trials by the Food and Drug Administration (FDA) in 2013.Objective To confirm the effect and safety of paroxetine for vasomotor symptoms (VMS).Search strategy MEDLINE, EMBASE, PsycINFO, CENTRAL, WHO International Clinical Trials Registry Platform (ICTRP) and four Chinese databases was searched from the date of their inception to 7 June 2014.Selection criteria We included RCTs on the effect of paroxetine compared with placebo or no treatment for perimenopausal and postmenopausal women who experienced moderate-to-severe vasomotor symptoms.Data collection and analysis Two reviewers screened records and extracted the information independently. The included studies were appraised by two independent reviewers using the Cochrane risk of bias tool. We synthesised the data in random-effects models and rated the quality of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach.Main results Five articles with six RCTs (1571 participants) were included. Paroxetine significantly reduced the frequency of hot flushes by 8.86 per week (95% confidence interval (CI) 5.69-12.04, P < 0.00001, I 2 = 83%) at week 4 and 7.36 per week (95% CI, 4.25-10.46, P < 0.00001, I 2 = 62%) at week 12. The quality of the evidence on the effect of paroxetine for VMS was moderate.Conclusions There was moderate quality of evidence supporting the effectiveness of paroxetine for vasomotor symptoms; however, it causes nausea and dizziness.Keywords GRADE, low dose paroxetine salt, meta-analysis, paroxetine, vasomotor symptoms.

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Section: Introductionmentioning

confidence: 99%

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Wei

Chen

et al. 2016

BJOG

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“…Paroxetine 7.5 mg is approved for vasomotor symptoms of menopause As many as 75% of menopausal women in the United States experience vasomotor symptoms related to menopause, or hot fl ashes and night sweats. 12 These symptoms can disrupt sleep and negatively affect quality of life. Though previously thought to occur during a short and self-limited time period, a recently published large observational study reported the median duration of vasomotor symptoms was 7.4 years, and in African American women in the cohort the median duration of vasomotor symptoms was 10.1 years-an entire decade of life.…”

Section: ■ Nonhormonal Treatment Formentioning

confidence: 99%

Women’s health 2015: An update for the internist

Kransdorf

McNeil

Files

et al. 2015

CCJM

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“…Although evidence supports SSRIs and SNRIs efficacy in reducing HFs (Carroll & Kelley ; Handley & Williams ), only paroxetine has been recently approved by the Food and Drug Administration (FDA) for the treatment of moderate‐to‐severe vasomotor symptoms associated with menopause (Orleans et al . ).…”

Section: Introductionmentioning

confidence: 97%

Duloxetine and escitalopram for hot flushes: efficacy and compliance in breast cancer survivors

et al. 2016

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Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) might be an effective treatment for hot flushes (HFs) in breast cancer survivors (BCSs). This study aims to compare the efficacy and tolerability of duloxetine (SNRI) versus escitalopram (SSRI) in reducing frequency and severity of HFs in BCSs and to assess the effect on depression. Thirty-four symptomatic BCSs with emotional impairment received randomly duloxetine 60 mg daily or escitalopram 20 mg daily for 12 weeks. Patients were asked to record in a diary HF frequency and severity at baseline and after 4 and 12 weeks of treatment. Depression was evaluated through validated questionnaires (Beck Depression Inventory and Montgomery Asberg Depression Rating Scale) at baseline and after 4 and 12 weeks of treatment. Both drugs showed a significant reduction of HF frequency and severity after 12 weeks of treatment with no significant difference between the two groups. A significant improvement in depression symptoms was observed at the end of the study period within both the groups, without difference between the two drugs. In conclusion, escitalopram and duloxetine are both effective treatment for the relief of HFs in BCSs, with similar beneficial effect. A significant improvement of depression was obtained with no major side effects.

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FDA Approval of Paroxetine for Menopausal Hot Flushes

Cited by 10 publications

References 0 publications

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Women’s health 2015: An update for the internist

Duloxetine and escitalopram for hot flushes: efficacy and compliance in breast cancer survivors

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