Risky old drug given a new gig — treating hot flashes

Is your doctor accidentally sneaking you this dangerous antidepressant?

If you’ve heard about the dangers of HRT and have been looking for an alternative, I hate to tell you this but…keep looking.

Because no matter what Noven Therapeutics wants you to believe, your wish, in fact, has NOT been granted.

But theirs certainly has.

NOT pretty in pink

Noven is putting its best marketing brains behind its newest brainchild for menopause symptoms.

But as soon as you look past the happy ladies on their website, you’ll easily see through all the hype.

First, what’s being sold to us as “new,” is nothing more than a watered down version of Paxil, that dangerous, old antidepressant. Noven gave it a makeover, a new website and a new name, Brisdelle.

But they can’t get rid of all the evidence of Paxil (known as paroxetine). It is a powerful antidepressant that carries the FDA’s strongest black box warning about suicidal behavior. And so will Brisdelle.

Noven must think women are pretty naive to fall for its marketing ploys — a magic lantern with a big pink Brisdelle pill in it. Smoke comes out of it leading us up to the message “your wish is granted.”

Really? I don’t know anyone who is wishing for suicidal thoughts, bone fractures, manic episodes and abnormal bleeding — all known side effects of Brisdelle.

But as usual with the FDA and Big Pharma, there’s more…

The FDA admits Brisdelle doesn’t even work for hot flashes. That makes a lot of sense if you read the Paxil label. Night sweats are actually one of the listed side effects for that drug!

You read that right. A risky drug approved to treat hot flashes actually causes night sweats.

Rubbing the magic FDA lamp

So how did Brisdelle get on the market in the first place? Especially when the drug got a loud NO vote from its advisory committee saying it was a lot less effective than a placebo.

In a “highly unusual” move last year, the FDA went ahead and approved Brisdelle anyway.

But the worst news for women is where Brisdelle really is “effective.” And that’s in the side effects department.

Originally approved in 1992, Paxil has become a magnet for lawsuits.

The company that makes it has spent billions over the years to settle these cases. And that includes $3 billion alone to the Department of Justice just to settle an investigation into how Paxil was marketed.

But none of those risks seemed to bother the FDA. And they certainly didn’t stop this “new” version of Paxil from being approved.

I know that hot flashes can be awful for some women, but they aren’t dangerous. So why would the FDA expect us to take such a high-risk drug to make them go away. Especially when they really don’t?

But those side effects aren’t the only problem. Look what could happen when you stop taking Brisdelle.

We know stopping Paxil can cause irritability, nausea, dizziness, vomiting, headaches, “sensations” on the skin, and mood swings. All things you are told that may come from menopause.

Hmmm…do we still have two more wishes?

Sources:
“Noven enters co-promotion agreement with Shionogi for Brisdelle (Paroxetine) capsules” January 13, 2014, prnewswire.com

“F.D.A. panel advises against two medicines to treat hot flashes” Andrew Pollack, The New York Times, March 4, 2014, nytimes.com