In late June (2013) the FDA approved paroxetine (Brisdelle) to treat hotflashes associated with menopause. Brisdell is a lower dose version of the drug Paxil, a selective serotonin reuptake inhibitor (SSRI). Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety, panic attacks, and a host of other psychiatric disorders. It’s a powerful drug with a long list of warnings, side effects, and drug interactions.

The Brisdelle website—complete with a lavender 1950s-style font—cheerfully announces, “Now Approved! The first and only FDA approved, non-hormonal therapy for hot flashes associated with menopause. Estimated availability in pharmacies: November 2013.”

Yay!

The overall look is inviting. The design is feminine with a vintage, penmanship-like font. And don’t you agree that the word therapy sounds less harmful than the word drug? Plus, the capsules are girlie-pink (sweet), but they come with a black box warning (not so sweet).

In clinical trials to test Brisdelle’s effectiveness, compared to a placebo (which also reduced hot-flashes), the drug was found to reduce the number of hot flashes by less than two per day (my emphasis).

What does “less than two per day” mean? One? None? So, the placebo worked just about as good as the drug, and I’m guessing, with no side effects.

Okay, let’s break this down. First off, hot flashes are no fun, but women don’t die from hot flashes. Menopause is not a disease, it’s part of a normal transition during aging. It’s a protective part of evolution.

Seriously, who wants to be pregnant at 60?

This from the drug’s website: The side effects of Brisdelle may include suicidal thoughts or actions, serotonin syndrome, abnormal bleeding, bone fractures, restlessness, and on and on. The most common possible side effects of Brisdelle include headache, tiredness, nausea, and vomiting.

I’m not exaggerating. In fact, I’m excluding some of the possible side effects at risk of sounding overly dramatic. In March, the FDA’s Advisory Committee for Reproductive Health Drugs (physician experts) voted 10 to 4 against recommending approval of paroxetine as a treatment for hot flashes. The panel felt the drug didn’t offer significant relief to warrant exposing women to the potentially dangerous side effects (like life-threatening or fatal). The FDA ignored the panel’s warning, convinced a “non-hormonal therapeutic option to help ease hot flashes” was necessary.

Yahoo Finance posted this article online on June 28th, which included Noven Pharmaceutical’s announcement of Brisdelle’s approval by the FDA. The article also contained this quote from David Portman, MD, who is a compensated consultant for Noven Pharmaceuticals.

“The FDA approval of Brisdelle addresses the unmet need for a clinically proven nonhormonal treatment option for hot flashes and night sweats,” said David Portman, M.D., Director of the Columbus Center for Women’s Health Research and Brisdelle clinical trial investigator. “As a clinician, the comprehensive prescribing information and proven data for Brisdelle enable me to confidently offer women with moderate to severe VMS a nonhormonal option that is safe and effective.”

Safe? Following Dr. Portman’s quote was the long list of possible side effects, including the black box warning.

Here are a few I found particularly interesting. Serotonin syndrome: nervousness, hallucinations, coma, or other changes in mental status; coordination problems; racing heartbeat; SWEATING (my emphasis) or fever; high or low blood pressure; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; FLUSHING (my emphasis); tremors; seizures.

Sweating and flushing? The possible side effects of a hot flash drug may include sweating and flushing? How can you tell which hot flash is natural and which is drug induced?

After some in-depth research on integrative medical therapies, I found some interesting alternatives. Aside from acupuncture, yoga, meditation, and exercise to help ease symptoms, daidzein- and genistein-rich isoflavones may be just as effective as Brisdelle, and without the dangerous side effects.

What are these chill-out isoflavones, you ask? And where do I get some?

Isoflavones are a group of molecules that are similar in chemical structure. They’re produced by plants of the Leguminosae family (legumes, beans) and when consumed, may behave like estrogen in the body. Foods that contain high amounts of isoflavones include soy, peanuts, chick peas, alfalfa, and fava beans. According to several clinical trials, some isoflavone metabolites may reduce the number and severity of hot flashes. I’d rather take my chances with a bowl of chickpeas, than a drug with a black box warning.

Post-yoga chickpea and jicama salad

What you need
2 cups cooked and drained chickpeas
1 cup coarsely grated jicama
1/2 cup coarsely grated carrots
1/2 cup corn kernels
1/4 cup chopped almonds
1/4 cup cup extra virgin olive oil
1/4 cup chopped parsley
2 tablespoons lemon juice
1 tablespoon wheat-free tamari
1 tablespoon thinly sliced chives

What you do
Place all ingredients in a bowl and toss to combine. Refrigerate for 30-45 minutes and let marinate before serving. Thinly sliced red pepper is also good in this salad. Be creative.

You might also like this roasted chickpea recipe from Shirley at Gluten-Free Easily or this chickpea gumbo recipe from Amie at The Healthy Apple.

Onward,
Melissa