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Non-Hormone Treatment for Hot Flashes Has Suicide Risk

Anonymous
Posted by Anonymous
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FDA approves Brisdelle, first nonhormonal treatment for hot flashes

Three-quarters of women suffer from hot flashes in menopause, and they can go on for 5 years or more


The FDA has a news flash for women who suffer hot flashes. It has approved the first nonhormonal treatment for the condition, which affects up to 75% of women and can drag on for 5 years or more.

The FDA said on Friday it had approved Brisdelle from Noven Therapeutics, which is a unit of Hisamitsu Pharmaceutical. The decision was a bit of a surprise, Reuters reports. While the FDA staff recommended approval, a panel of experts in March voted not to recommend it, saying its risks outweighed its benefits.

The drug contains paroxetine, the same ingredient found in the popular antidepressant and antianxiety drug Paxil, and so carries a boxed warning about the risk of suicide associated with its use in children and young adults. Brisdelle contains 7.5 mg of paroxetine, less than Paxil, the agency said. A medication guide about the risk and other important information will be included with each refill.

Other treatments are approved for hot flashes, but they all contain estrogen alone or estrogen plus a progestin, and many women do not want to take those, the FDA pointed out. Hormonal treatments used to be commonplace, but their popularity fell off more than a decade ago after a large study tied them to an increased risk of breast cancer. Drugmakers, like Pfizer ($PFE), have spent years defending or settling litigation tied to that issue.   

- here's the FDA release
more from Reuters



Read more: FDA approves Brisdelle, first nonhormonal treatment for hot flashes - FiercePharma http://www.fiercepharma.com/story/fda-approves-brisdelle-first-nonhormonal-treatment-hot-flashes/2013-06-28#ixzz2XstzR5FD 
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Posted by Anonymous on Jul. 2, 2013 at 6:56 AM
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DejaVooDoo
by Silver Member on Jul. 2, 2013 at 8:21 AM

That tells me that no one can win lol. You either take the hormone replacement or you take a non hormonal replacement and something is going to harm you :/

I'm in menopause at 34 years old due to secondary ovarian failure. Without estrogen, progesterone and testosterone the life in me just 'flat lines'. No sex drive, no interest (at all) in the opposite sex, no vitality, no energy and HEAPS of hot flashes that come and go. I was told I was way too young to 'not' take sexual hormone replacement. The risk of heart disease and osteoperosis increases over double fold in younger women who don't carry enough of these three hormones. Tried HRT patches which supposedly have a higher than normal risk than the pill (even though the pill can cause blood clots) and breast cancer, but to tell you the truth I would rather go the hormonal route than try something like this. My metabolism and energy is in a pile of shit without them. Hoping to start new sex hormone replacement in the next month or so, but regular ongoing breast exams and overall health are crucial when starting anything to offset fluctuating hormones. As for this though, I would never want or have a need to try it.

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