Brisdelle (a Paxil imitator) for Menopausal Hot Flushes

 

Majid Ali, M.D.

Paxil for Menopausal Hot Flashes. Really!

Majid Ali, M.D.

To my great surprise, in early 2014, the Food and Drug Administration (FDA) approved Paxil by another name (Brisdelle, a brand of paroxetine) for treating hot flushes associated with menopause. What did not surprise me about this was that this approval was strongly opposed by FDA’ own advisory committee ( Reproductive Health Drugs Advisory Committee), Specifically, Committee, the Committee had concluded, by a vote of 10 to 4, that the overall benefit–risk profile of the drug did not justify its approval.

The Drugs Advisory Committee duly pointed out that the drug had taken teenagers life by inducing suicides.

Over the decades of my clinical work, I have had my share of patients whose lives were made miserable by menopausal hot flushes. Never once did I find it necessary to consider any antidepressant drugs for controlling this problem.

Causes of Severe Menopausal Hot Flushes

Severe menopausal hot flushes are heightened vascular (vaso-motor) responses to hormonal disruptions rooted in disturbances in the bowel-blood-liver axis. How do I know this? Severe hot flushes of my patients were controlled only after I addressed these problems along with a program of hormonal normalization with naturally-derived hormones, guided by blood hormone tests.

My Seven for Menopausal Hot Flushes

Following are the seven main components of my program (presented in detail in the companion article entitled “Integrrative Program for Menopausal Syndrome.”

* Insulin-reduction diet

* Optimal Hydration

* Progesterone

* Estrogen

* Folic acid

* DHEA

* Elimination or reduction of caffeine intake

How Effective is Brisdelle (a Paxil imitator) for Menopausal Hot Flushes

Minimal, even if the company data is believed. Below is text from The New England Journal of Medicine (May 8, 2014) on this subject: Doubtful. The efficacy of Brisdelle was established in two randomized, double-blind, placebo-controlled, multicenter clinical trials. Among a total of 1184 menopausal women who had a median of 10 moderate-to-severe hot flushes per day, Brisdelle was shown to provide modest relief in comparison to placebo. For example, at week 12 in one study, there was a median reduction from baseline of 5.9 moderate-to-severe hot flushes per day with Brisdelle as compared with a median reduction of 5.0 per day with placebo (median treatment difference, 0.9; P<0.01). At week 12 in the second study, there was a median reduction from baseline of 5.6 moderate-to-severe hot flushes per day with Brisdelle as compared with a median reduction of 3.9 per day with placebo (median treatment difference, 1.7; P<0.001).”

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