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!
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.
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