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Paroxetine For Hot Flashes

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Last Updated: 18 January 2022

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General | Latest Info

One pharmaceutical company can now brag about nonhormonal to treat Hot Flashes during Menopause. Noven Therapeutics know that's welcome news to scores of women who ve developed fear of hormone therapy following increased risk of heart disease and Breast Cancer see in Women's Health Initiative. But Brisdelle is just old dressed up in new feminine name and packaging - it's antidepressant PAROXETINE, better known by its brand name, Paxil. Some women won t even know it is antidepressant, say Diana Zuckerman, PhD, president of National Center for Women & Families, Women's Health advocacy group, explaining that few May look at generic name, and of those who do, PAROXETINE will be much less recognizable than Paxil. Using Antidepressants in is not new. Gynecologists have long been using them off - label to treat Hot Flashes, particularly in women who can t tolerate hormone therapy - including those with history of heart disease, blood clots, deep vein thrombosis, and stroke. In theory, selective serotonin reuptake inhibitors like PAROXETINE work for Hot Flashes because serotonin is thought to play role in regulating body temperature. But questions remain as to whether antidepressants are actually in this condition. There are no large studies of their - label use in Hot Flashes, and efficacy findings in Brisdelle studies were questionable - so much so that FDA's own Advisory Committee recommended against approving drug for Hot Flashes. In March, that panel voted 10 to 4 against approval because it was concerned that drug's benefits didn t appear to outweigh its risks. Members say there was difference in Hot flash frequency whether patients were on Drug or on placebo. Some panelists also expressed concerns about risk of suicidal thinking, for which antidepressant formulation carry black box warning. Overall incidence of these adverse events didn t differ much between two groups during trial, but Zuckerman note that patients with history of depression or suicidal ideation were excluded from trials. Some doctors might assume that's not BIG deal, and if woman starts feeling depressed or suicidal, she can stop taking drugs, Zuckerman say. But when person feels depressed or suicidal, they don t think clearly. They may not fully realize it is caused by because they start to feel bad about themselves or their lives. If they do realize effects, she say, stopping medication quickly can be dangerous: there's rebound effect that be very harmful. So, it's not simple matter to try it and stop if it isn t working, she say. Although it takes advice of its Advisory committees, FDA isn t bind by their decisions. So in June, it went ahead and gave Brisdelle green light anyway, potentially because it saw dearth of options for Hot flash treatment. This certainly isn t first time antidepressant drug maker has tried to seek gynecologic indication for its drug.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Results

In total, 614 participants were randomly assigned to 12 - week study, and 570 participants were randomly assigned to 24 - week study; overall, more than 80 percentage of women completed studies, and most were at least 80 percentage compliant with study drug treatment. 30 For pool analysis, modified intent - to - treat population comprise 1, 174 women, and population comprise 1, 175 women. 1. Demographic characteristics were not notably different between treatment arms at baseline, although statistical analyses were not performed on baseline demographic variables table. 1. At baseline, SD daily frequency of VMS daytime plus nighttime was 11. 3 4 in both groups. 30 Sleep - related characteristics at baseline were also similar between treatment arms: participants experienced mean SD of 3. 6 2 nighttime awakenings attributed to VMS or 25 per week and that hot flashes interfere with sleep to large extent, with overall mean HFRDIS score of 7. 6 table table1 1.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Search criteria

Results of Womens Health Initiative study 1 of Hormone therapy in postmenopausal Women, published in 2002, have prompted many women and primary care physicians to reconsider use of estrogen and progesterone Hormone therapy to alleviate hot flashes. In study, 1 16, 608 healthy, postmenopausal Women with intact uterus were randomized to receive therapy with conjugated equine estrogens plus medroxyprogesterone acetate, or placebo. Study was stopped early because researchers found increased incidences of breast cancer, coronary heart disease, stroke, and pulmonary embolism in treatment group when compared with placebo group. 1 Many women find risks associated with hormone therapy to unacceptable and are requesting non - hormonal therapies to manage their Hot flash symptoms. There have been numerous reports in medical literature and general media as to effectiveness of various over - counter and prescription agents reducing menopausal Hot flash symptoms. Following Is Review Of Published Data For Several Of These Agents. Key recommendations for different regimens are listed in strength of recommendations Table, with study duration and dosages used Study considerations and limitations are listed in Table 2. 2 - 33 potential confounder in most hot flash trials placebo response rate, which in studies evaluated for this review was reported as between 18 and 40 percent. This is similar to rates found in studies of hormonal agents, but makes it more difficult to ascertain true effects of therapy on hot flashes. Numerous reports in medical literature and popular media have discussed effectiveness of various nonhormonal agents in reducing menopausal Hot flash symptoms. Data for these therapies is limit, and most of have been conducted in women with history of breast cancer. Selective serotonin reuptake and venlafaxine have been shown to reduce hot flashes by 19 to 60 percent and were well tolerated by study participants. Soy isoflavones reduce hot by 9 to 40 percent in some trials, but most trials show no difference compared with placebo. Black cohosh and red clover also have had inconsistent results, with some trials showing benefit and some difference compared with placebo. Soy isoflavones, black cohosh, and red clover were tolerated in clinical trials. Other agents that have been used to alleviate hot flashes include belladonna / ergotamine tartrate / phenobarbital combination, dong quai, evening primrose oil, gabapentin, ginseng, mirtazapine, vitamin E, and wild yam, but little data regarding their effectiveness has been publish. Further randomized control are needed

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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