Give Them Hell, Brisdelle

Back in 2013 I wrote about the FDA's approval of an apparent 'new' drug to treat hot flashes during menopause.

The perfectly pink packaged Brisdelle is now being shown on US TV screens, a marketing strategy aimed, of course, at women.

The 60 second ad avoids telling the viewer that what is actually being advertised is a chemical compound called paroxetine, better known to millions of US citizens as Paxil, an antidepressant with a less than savoury history.

Brisdelle is 7.5mg of Paxil with a new brand name, by adding Paxil to the combination the patient will actually be overdosing.

Another antidepressant, Wellbutrin, is also marketed for different uses, once again under a different brand name - Zyban. For those that don't know Zyban is a smoking cessation drug cum antidepressant - exactly the same as Brisdelle is a drug to treat hot flashes cum antidepressant.

Quite why the FDA granted a licence to Brisdelle knowing what they know about Paxil astonishes me.

Let's watch the 60 second ad... pay attention to what the voice-over says, it follows the words, "Call your doctor if". Then listen to the same voice-over list the three apparent 'played down' side effects..

Tell your doctor if you are allergic to paroxetine?

Quite a spin - it probably means tell your doctor if you have taken paroxetine before and suffered its multitude of side effects, which include; suicidal ideation, completed suicide, birth defects and addiction to name but a few.

Last month Dr Evan Levine wrote a brilliant piece regarding Brisdelle. Levine wrote the column for the Ridgefield Press and made some astute comments.

For me, it’s yet another example of Big Pharma exploiting an unwary public with the phrase “Approved by the Food and Drug Administration.” Brisdelle is the trade name of a drug that has been available for years as a cheap generic, paroxetine, also known as Paxil, now rebranded and sold in a dose that is both convenient for the manufacturer and equally inconvenient for the consumer.

At 12 weeks into treatment, those patients who took this antidepressant (Brisdelle) had, on average, 5.9 fewer hot flashes and those patients who took the placebo had 5.0 fewer hot flashes; again statistically fewer hot flashes for those who took the Brisdelle, but not even less than one fewer hot flashes a day when compared to the nothing-pill. A quick review of the data and you’ll notice that the subjects taking the placebo for three months actually had fewer hot flashes than the patients who took it for a month!

Levine continues with...

And now the most disturbing part. The FDA’s independent advisory committee voted 10-4 not to approve Brisdelle, in March of 2013, on the grounds that it did not provide sufficient benefits. Yet the FDA went ahead and approved it anyway! The FDA rarely approves a drug that has more negative than affirmative votes.

Great observation from Levine.

We can't point the finger at GlaxoSmithKline for this one folks. It's Noven Therapeutics who market Brisdelle.

My advice to women suffering from hot flashes is simple. Stay away from Brisdelle, your reaction to it could cost you your life.

Further reading on the risks of paroxetine here.


Bob Fiddaman.

Shionogi to Co-Promote Paroxetine Use in Menopausal Women

Back in June last year I wrote about how the FDA had approved a rebadged version of Paxil for women who suffered hot flushes.

The unsuspecting public [women] will now be greeted with a perfect pink package with the brand name Brisdelle emblazoned on it.

So, how can a pharmaceutical company possibly promote paroxetine given it's horrendous side effect profile?

Simple...hire another pharmaceutical company to co-promote it for you.

Step forward Shionogi, a U.S.-based group company of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. Their global mission? "Shionogi strives constantly to supply the best possible medicine to protect the health and wellbeing of the patients we serve." 

Shionogi's women's health sales force will now promote Brisdelle in the US to a range of healthcare providers, including some primary care doctors.

Wouldn't you just love to be a fly on the wall for this particular promotion?

No doubt Shionogi's managers will train their sales force well. You know, questions to avoid, how to use clinical information spin, how to avoid potential lawsuits, how to play down the side effect profile of paroxetine...etc. Maybe they could ask GlaxoSmithKline how they promoted Paroxetine use in kids and pregnant mothers before they were caught out by the authorities?

I'm going to cut and paste the post I did back in June last year. It pretty much sums up how Brisdelle could be promoted... and probably will be.

Saturday, June 29, 2013

FDA Approve Re-badged Paxil for Hot Flashes - By Bob Fiddaman

Those 'wise' folk over at the FDA in the US have gave the thumbs up for a new drug that's hit the market.

Brisdelle, marketed by Noven Therapeutics, LLC, is in fact a low dose of Paxil [Known as Seroxat in the UK and Aropax in the southern hemisphere].

The drug, which apparently treats moderate to severe vasomotor symptoms [that's hot flashes and night sweats to you and me] will be available in US pharmacies by November 2013.

Ah, the good old FDA approving Paxil yet again for conditions that will no doubt increase the risk of suicide and/or homicide in this patient population.

Brisdelle is a low dose treatment of Paxil, trust me, there ain't no such thing, any dose of Paxil is too much.

Noven Therapeutics claim that "At the unique low dose of 7.5mg of paroxetine as a mesylate salt, Brisdelle was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause." They add, "Brisdelle contains a lower dose of paroxetine than is indicated for any other condition."

Indications mean nothing, we all know that. This approval basically means Brisdelle will be prescribed for a whole host of conditions. It's perfect for pediatrics out there to prescribe off-label. Only 7.5mg you see, much safer, they will have parents believe, than a single 10mg tablet [currently the lowest single tablet dose]

Hooray, finally a treatment for something that is perfectly natural. I'm not scoffing at this problem, obviously I'm just a guy and, thankfully, I'll never have to experience something like menopause.... wait a minute...

Let's go back in time, just so I can show you how pharmaceutical companies work.

The website andropause.com was launched in 1999. Here's what they were saying about male menopause. [1]

The existence of Andropause is now recognized by the medical world - including the Canadian Andropause Society - and by Canadians alike.

In fact, a recent Angus Reid survey found that 70% of the general public share the belief that men experience a mid-life stage similar to women's menopause. Andropause (also called "male menopause") is a normal part of aging; although, for some men it is accompanied by a gradual and undesired decline in their sexuality, mood and overall energy. Sometimes it can even expose men to more serious health risks.

As with women, Andropause begins at a time when life often offers some of its greatest rewards.

There was even an "Andropause Quiz" for males to take. [2]

So, what is Andropause?

Well, here's what the website told us back in 1999: [3]

By the time men are between the ages of 40 and 55, they can experience a phenomenon similar to the female menopause, called Andropause. Unlike women, men do not have a clear-cut external signpost such as the cessation of menstruation to mark this transition.

Unlike menopause, which generally occurs in women during their mid-forties to mid-fifties, men's "transition" may be much more gradual and expand over many decades.

Although with age, a decline in testosterone levels will occur in virtually all men, there is no way of predicting who will experience Andropausal symptoms of sufficient severity to seek medical help.

Medical help?

The website made claims that "Andropause was first described in medical literature in the 1940's. So it's not really new. But, our ability to diagnose it properly is."

By March 2002 the website changed in appearance and, in addition to explaining what Andropause was, they now had a treatment for it.

Andriol.

Hey, and if you wanted to know more about this treatment there was even a special website for you to read about it, andriol.com.

Here's how andropause.com looked in 2002. [Fig 1]

Fig 1

Both andropause.com and andriol.com carried the copyright symbol of NV Organon.

By 2006 that symbol was clickable. You'd never guess in a million years where it led to? [Fig 2]

Fig 2

In fact, click on both links today and see where you are redirected to. Try them

andropause.com 

andriol.com

Just cut and paste them into your browser. I won't hyperlink them because you need to do this for yourselves folks.

So, having covered the marketing of a drug to treat [ahem] andropause lets now turn our attention back to the 7.5mg Paxil pill, to be marketed as Brisdelle.

What you won't hear in the huge marketing campaign that will no doubt ensue are the side-effects to this drug.

This from the Brisdelle webpage:

Suicidal thoughts or actions:  

BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

The website then goes on to tell us, "Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions."

But wait, Brisdelle isn't for depression or other serious mental illnesses is it?

They also warn you to call your healthcare provider right away if you have any of the following symptoms:

Serotonin Syndrome: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.

Manic Episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.

The restlessness they refer to is more commonly known as akathisia.

Akathisia has been studied as the mechanism by which SSRI-induced suicidality occurs and can be reduced by withdrawing or decreasing the dose of the causative agent.

In other words, if you take Brisdelle it may induce your own suicide.

Most strikingly the makers of Brisdelle have gone out on a limb. It's a refreshing move. They write the following:

Do not take BRISDELLE if you:

Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.

Nice job Noven Therapeutics!

I've screen captured the above line for prosperity [Fig 3]

Fig 3

I'm unsure what clowns at the FDA granted license to this particular brand of Paxil. I can, however, be reasonably sure that more and more women are going to become addicted to this very powerful drug. But hey, don't worry about your addiction, that's easy enough to cure - just wrap a rope around your neck, pop a hose in a car, aim that gun at your head - Bang - addiction over.

Brisdelle [7.5mg of Paxil] is the new kid on the block.

I'm guessing that Noven Therapeutics pharmaceutical reps will have those cheque books ready to dine and dash those pediatric quacks and ask them to prescribe off-label. They may as well, every other pharmaceutical company who have manufactured SSRis have done it.

Bob Fiddaman

[1] andropause.com [1999]
[2] Andropause Quiz [1999]
[3] What is Andropause? [1999]

FDA Approve Re-badged Paxil for Hot Flashes

Paxil comes in all shapes and sizes

Those 'wise' folk over at the FDA in the US have gave the thumbs up for a new drug that's hit the market.

Brisdelle, marketed by Noven Therapeutics, LLC, is in fact a low dose of Paxil [Known as Seroxat in the UK and Aropax in the southern hemisphere].

The drug, which apparently treats moderate to severe vasomotor symptoms [that's hot flashes and night sweats to you and me] will be available in US pharmacies by November 2013.

Ah, the good old FDA approving Paxil yet again for conditions that will no doubt increase the risk of suicide and/or homicide in this patient population.


Brisdelle is a low dose treatment of Paxil, trust me, there ain't no such thing, any dose of Paxil is too much.

Noven Therapeutics claim that "At the unique low dose of 7.5mg of paroxetine as a mesylate salt, Brisdelle was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause." They add, "Brisdelle contains a lower dose of paroxetine than is indicated for any other condition."

Indications mean nothing, we all know that. This approval basically means Brisdelle will be prescribed for a whole host of conditions. It's perfect for pediatrics out there to prescribe off-label. Only 7.5mg you see, much safer, they will have parents believe, than a single 10mg tablet [currently the lowest single tablet dose]

Hooray, finally a treatment for something that is perfectly natural. I'm not scoffing at this problem, obviously I'm just a guy and, thankfully, I'll never have to experience something like menopause.... wait a minute...

Let's go back in time, just so I can show you how pharmaceutical companies work.

The website andropause.com was launched in 1999. Here's what they were saying about male menopause. [1]

The existence of Andropause is now recognized by the medical world - including the Canadian Andropause Society - and by Canadians alike.

In fact, a recent Angus Reid survey found that 70% of the general public share the belief that men experience a mid-life stage similar to women's menopause. Andropause (also called "male menopause") is a normal part of aging; although, for some men it is accompanied by a gradual and undesired decline in their sexuality, mood and overall energy. Sometimes it can even expose men to more serious health risks.

As with women, Andropause begins at a time when life often offers some of its greatest rewards.

There was even an "Andropause Quiz" for males to take. [2]

So, what is Andropause?

Well, here's what the website told us back in 1999: [3]

By the time men are between the ages of 40 and 55, they can experience a phenomenon similar to the female menopause, called Andropause. Unlike women, men do not have a clear-cut external signpost such as the cessation of menstruation to mark this transition.

Unlike menopause, which generally occurs in women during their mid-forties to mid-fifties, men's "transition" may be much more gradual and expand over many decades.

Although with age, a decline in testosterone levels will occur in virtually all men, there is no way of predicting who will experience Andropausal symptoms of sufficient severity to seek medical help.

Medical help?

The website made claims that "Andropause was first described in medical literature in the 1940's. So it's not really new. But, our ability to diagnose it properly is."

By March 2002 the website changed in appearance and, in addition to explaining what Andropause was, they now had a treatment for it.

Andriol.

Hey, and if you wanted to know more about this treatment there was even a special website for you to read about it, andriol.com.

Here's how andropause.com looked in 2002. [Fig 1]

Both andropause.com and andriol.com carried the copyright symbol of NV Organon.

By 2006 that symbol was clickable. You'd never guess in a million years where it led to? [Fig 2]

andropause.com and andriol.com

In fact, click on both links today and see where you are redirected to. Try them

andropause.com 

andriol.com

Just cut and paste them into your browser. I won't hyperlink them because you need to do this for yourselves folks.

So, having covered the marketing of a drug to treat [ahem] andropause lets now turn our attention back to the 7.5mg Paxil pill, to be marketed as Brisdelle.

What you won't hear in the huge marketing campaign that will no doubt ensue are the side-effects to this drug.

This from the Brisdelle webpage:

Suicidal thoughts or actions:  

BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

The website then goes on to tell us, "Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions."

But wait, Brisdelle isn't for depression or other serious mental illnesses is it?

They also warn you to call your healthcare provider right away if you have any of the following symptoms:

Serotonin Syndrome: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.

Manic Episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.

The restlessness they refer to is more commonly known as akathisia.

Akathisia has been studied as the mechanism by which SSRI-induced suicidality occurs and can be reduced by withdrawing or decreasing the dose of the causative agent.

In other words, if you take Brisdelle it may induce your own suicide.

Most strikingly the makers of Brisdelle have gone out on a limb. It's a refreshing move. They write the following:

Do not take BRISDELLE if you:

Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.

Nice job Noven Therapeutics!

I've screen captured the above line for prosperity [Fig 3]

No if's or but's about it. Paroxetine CAN harm your baby. [Click image to enlarge]

I'm unsure what clowns at the FDA granted license to this particular brand of Paxil. I can, however, be reasonably sure that more and more women are going to become addicted to this very powerful drug. But hey, don't worry about your addiction, that's easy enough to cure - just wrap a rope around your neck, pop a hose in a car, aim that gun at your head - Bang - addiction over.

Brisdelle [7.5mg of Paxil] is the new kid on the block.

I'm guessing that Noven Therapeutics pharmaceutical reps will have those cheque books ready to dine and dash those pediatric quacks and ask them to prescribe off-label. They may as well, every other pharmaceutical company who have manufactured SSRis have done it.

Bob Fiddaman

[1] andropause.com [1999]
[2] Andropause Quiz [1999]
[3] What is Andropause? [1999]