First Non-Hormonal Remedy Approved for Menopausal Hot Flashes07/01/13
MONDAY, July 1 (HealthDay News) -- Brisdelle (paroxetine) has
been approved by the U.S. Food and Drug Administration as the first
non-hormonal treatment to treat hot flashes associated with
All prior FDA-approved drugs for hot flashes contain either the
hormone estrogen alone or the hormonal combination of estrogen and
progestin, the agency said in a news release.
Brisdelle's active ingredient is paroxetine, in a smaller amount
than the same active ingredient in the antidepressant Paxil. It's
not understood how paroxetine treats hot flashes, the FDA said.
Hot flashes affect up to 75 percent of all women, and can linger
for as long as five years. Briselle's safety and effectiveness in
treating the condition were evaluated in clinical studies involving
1,175 post-menopausal women with moderate-to-severe hot flashes.
The most common side effects of the once-daily drug were headache,
fatigue and nausea/vomiting.
Paroxetine, a selective serotonin reuptake inhibitor (SSRI), has
the same boxed label warning as other antidepressant drugs in its
class. The label warns of possible increased risk of suicide among
children and young adults.
Brisdelle's label also warns of a possible reduction in the
effectiveness of tamoxifen -- a drug prescribed to treat breast
cancer -- if both medications are taken together. Other potential
serious side effects include increased risk of bleeding and
developing a condition called serotonin syndrome, the FDA said.
Brisdelle is marketed by Noven Therapeutics, based in Miami,
To learn more about this
approval, visit the FDA.
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