Paroxetine, formerly known as low-dose mesylate salt of paroxetine (LDMP), is a nonhormonal agent, which makes it an alternative hot flash therapy for menopausal women who cannot or do not want to use hormones. Low dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. The US Food and Drug Administration (FDA) recently approved paroxetine mesylate 7.5 mg (Brisdelle) for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). Poster presented at: 2014 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG); April 26–30, 2014; Chicago, IL. Presented at: 2012 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists; May 7, 2012; San Diego, CA. Safety profile of paroxetine 7.5 mg in women with moderate to severe vasomotor symptoms. Low-dose mesylate salt of paroxetine (LDMP) in treatment of vasomotor symptoms (VMS) in menopause. Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Paroxetine mesylate (Pexeva, Brisdelle) and paroxetine hydrochloride (Paxil, and generics) are two salts of the same active compound (paroxetine). The efficacy and safety of paroxetine mesylate, a selective serotonin-reuptake inhibitor (SSRI), were evaluated individually in three Phase 2 or 3 multicenter, double-blind, randomized, placebo-controlled trials, published by James Simon, MD, from George Washington University School of Medicine, and colleagues, presented April 29, at the 2014 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG) in Chicago, Illinois, Simon and colleagues further reported on the overall tolerability and safety profile of paroxetine mesylate 7.5 mg using pooled data from the three randomized trials. In their post-hoc analyses, they specifically examined the emergence of adverse events linked to the use of SSRIs when prescribed for psychiatric disorders at therapeutically higher doses than 7.5 mg. fluoxetine Prozac paroxetine Paxil venlafaxine Effexor escitalopram Lexapro For the fist time in its history the FDA recently approved an SSRI antidepressant, Brisdelle, also named Paxil (paroxetine), for the treatment of menopausal hot flashes.(1) The clinical trial which generated the data for FDA approval was funded by Noven Pharmaceuticals. Instead of using hormone replacement as a treatment for menopausal hot flashes, mainstream medicine docs will sometimes prescribe SSRI antidepressants off-label.(22-26) Off-label use means that the SSRI drug has not been FDA approved for treatment of menopausal symptoms of hot flashes. The lead author of the study was James A Simon, an MD who disclosed financial relationships with Noven and thirty other pharmaceutical companies. (2-4) The FDA approved the paroxetine drug against the vote of an FDA advisory committee. They voted 10-4 against approval in a meeting held March 2013. (5-17) Click here for a transcript of the FDA meeting.: Transcript_FDA_Advisory _MArch_2013. Mary Carol Jennings made a statement against approval to the FDA Advisory Committee because the drug carries adverse effects which outweigh any potential benefit. Simon’s Brisdelle (paroxetine) clinical trial started with about 10 hot flashes per day. After 12 weeks, those on paroxetine had 4 hot flashes per day compared to 5-6 for the placebo group.
There are a number of different treatment options to consider if menopause is disrupting your life. The most common symptoms include hot flashes, night sweats, mood problems, trouble sleeping, and vaginal dryness. Treatment with estrogen and progesterone, called combination hormone replacement therapy (HRT), can be prescribed for women who still have their uterus, if they have moderate to severe symptoms of menopause. Estrogen alone is the prescribed regimen for women who have had a hysterectomy (no longer have their uterus). These are the most effective treatments for hot flashes, and can also help with vaginal dryness and mood problems. Hormonal patches, creams, gels, and vaginal rings are alternatives to the traditional pills, depending on the symptoms. Treatment is usually started before age 60 and taken up to 5 years. These women include those with breast or uterine (endometrial) cancer, blood clots, liver disease, heart disease stroke, women who may be pregnant, or who have undiagnosed vaginal bleeding. If you are unable or do not want to take hormones, there are treatments that your doctor can prescribe to alleviate some of the symptoms of menopause. If you have vaginal dryness without hot flashes, you can try vaginal estrogen. Your doctor can usually diagnose hot flashes based on a description of your symptoms. Your doctor might suggest blood tests to check whether you're in menopausal transition. The most effective way to relieve the discomfort of hot flashes is to take estrogen, but taking this hormone carries risks. If estrogen is appropriate for you and you start it within 10 years of your last menstrual period or before age 60, the benefits can be greater than the risks. Medications such as antidepressants and anti-seizure drugs also might help reduce hot flashes, although they're less effective than hormones. Discuss the pros and cons of various treatments with your doctor. If hot flashes don't interfere with your life, you probably don't need treatment.
What is paroxetine Brisdelle, and how does it work mechanism of action?; What brand. Quick GuideMenopause & Perimenopause Symptoms, Signs. Aug 12, 2015. Women taking Paroxetine had a mean weekly reduction of 28.9 fewer hot flashes compared with reduction of 19.0 fewer hot flashes for women.