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.
Low-dose paroxetine (Brisdelle) treatment does not cause weight gain or sexual dysfunction when used in women with menopausal hot flashes, according to exploratory analyses of pooled data from a pair of phase 3 trials. “Many physicians and patients are aware of reports of sexual dysfunction and changes in body weight in patients taking selective serotonin reuptake inhibitors (SSRIs) and, specifically, paroxetine at the higher doses used for depression and other psychiatric disorders,” said study co-author Joel Lippman, MD, FACOG, executive vice president of product development and chief medical officer for Noven, which manufactures Brisdelle. “This may be an important factor when considering treatment for moderate to severe hot flashes, and these analyses, with their limitations, may help provide physicians with a better understanding of Brisdelle.” For their analyses published in the October 2014 issue of , researchers evaluated the impact of once-daily Brisdelle 7.5 mg capsules on body weight and sexual function in postmenopausal women aged 40 years or older who experienced moderate to severe vasomotor symptoms (VMS). After 24 weeks of treatment, the investigators found no clinically meaningful or statistically significant changes in weight or sexual function from baseline in either trial’s paroxetine group. By comparison, they observed small yet statistically significant increases in weight in the pooled placebo arm at week 4. In terms of limitations, the authors noted that the study was not specifically designed to evaluate sexual dysfunction in VMS, and it had a relatively short duration of treatment and follow-up. Although Brisdelle received FDA approval in June 2013 for the treatment of moderate to severe VMS associated with menopause, the low-dose SSRI has not been studied or approved for any psychiatric use. Your face and chest feel intensely hot, your skin reddens, and you're soaked in sweat. How much they interfere with a woman's quality of life varies greatly, and most of them will have only mild to moderate ones. Hot flashes—whether debilitating, embarrassing, or merely annoying—are inevitable for most menopausal women, with about 70 percent experiencing some symptoms. But they will be more severe for about 20 percent of women. Until recently, menopausal hot flashes were routinely and successfully treated with medicines containing various forms of the female hormones estrogen and progestin. But in 2002 a large clinical trial found that those hormones increased the risk of heart disease, stroke, blood clots, breast cancer, urinary incontinence, and dementia. The increased risks were small but noteworthy on all accounts. (Although more recent research has found that women ages 50 to 59 who have a low risk of heart disease or breast cancer and who started menopause within the past five years might be candidates for low-dose hormone therapy if their symptoms are severe.
Paroxetine, formerly known as low-dose mesylate salt of paroxetine LDMP, is a nonhormonal agent, which makes it an alternative hot flash therapy for. Dec 20, 2017. These are the most effective treatments for hot flashes, and can also help. will go a long way towards minimizing the symptoms of menopause.