Hot flashes = hot market for Noven

16 million women put up with moderate to severe hot flashes because the hormone therapy drugs offered have side effects that are worse than the benefits. 8 million more women find the hot flashes so incapacitating that they take the drugs available, even though the  estrogen in the drugs has dire risks.

Noven Pharma wants that market. They estimate the number of women with moderate to severe hot flashes at 24 million. “…two-thirds of whom are not currently treating these often debilitating symptoms,” salivated, I mean stated, Joel Lippman, MD, FACOG and Noven exec vp. Hot flashes are distressing, embarrassing and distracting from what one wants to be doing (like sleeping, talking, living one’s life). However, the only options available previously were estrogen-based and come with an increased risk of gallstones, breast cancer, blood clots, stroke, heart disease, etc. (See our page on Long-Term Effects of Menopause Drugs for more articles and studies on hormone replacement therapy.)

Noven has somehow gotten their product, Brisdelle approved by the FDA despite the fact that the FDA Committee reviewing the studies recommended against approving it, citing the fact that it’s efficacy was only marginally better than a placebo. What does marginally mean? Noven studied women suffering with 10 or more hot flashes a day. Brisdelle lowered the number of hot flashes by about 6. But the placebo lowered the number of hot flashes by 4 to 5! What’s in that placebo? That’s what I want.

Side Effect Brisdelle Placebo
lowered hot flashes from 10 to 4 per day lowered hot flashes from 10 to 5.5 per day
Headache 6.30% 4.80%
Fatigue/malaise/lethargy 4.90% 2.80%
Nausea/vomitting 4.30% 2.30%

Of these commonly reported adverse reactions, nausea occurred primarily within the first four weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy. Brisdelle shares paroxetine warnings and precautions. (Source: Pharmabiz.com)

Brisdelle is paroxetine, the ingredient in Paxil that led to suicidal thoughts. Brisdelle has a lower amount of paroxetine than Paxil has, but the warning on the Brisdelle box will be the same as on Paxil. And all this for a drug the FDA Committee called minimally effective.(source: New York Times)

MedShadow Foundation does not give out medical advice. But if I had impossible-to-deal-with hot flashes, I’d get the placebo.

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Suzanne B. Robotti

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.


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