Sunday, June 30, 2013

Another "Wonder Drug" is on its way.


I've written before about how much I hate "me-too" drugs.

I think I've just found the worst offender of them all...and it hasn't even been released yet.

Two days ago, the FDA approved the "first" non-hormonal drug to treat hot flashes in menopausal women.  First- a bit of background.  Hot flashes are an extremely common symptom of menopause- it's estimated that up to 80% of women will experience them.  Hot flashes are caused by fluctuations in hormone levels causing blood vessels to dilate.  At best, hot flashes are a minor annoyance.  At worst, they are truly debilitating, happening several times an hour and interfering with work and sleep.

For decades, the mainstay of therapy for symptoms of menopause was hormone replacement therapy.  This consists of giving women small dosages of estrogen and progesterone, the two main "female" hormones that decrease during menopause.  Then, in 2002, the preliminary results of the Women's Health Initiative Study were released.  This showed a significant increase in the incidence of breast cancer in women who were on hormone replacement therapy versus women who were not.  Mass panic ensued.  Over the next few years, doctors wrote 70% fewer prescriptions for HRT.  As the years have passed, more information has be released and more data obtained, suggesting that the increased risk of breast cancer is not all that clear-cut.

However, the damage was done, and women have been suffering from hot flashes, afraid to try HRT.  This of course sparked an interest in finding non-hormonal treatments for menopausal symptoms.  Doctors have been using types of anti-depressants, SSRIs and SNRIs for years.  They work, a bit.  None of the studies have honestly been that impressive.  Some show a slight benefit, others are barely better than placebo.

I guess that a certain pharmaceutical company has decided that the combination of hot flashes and fear of HRT is a cash cow.  As I said above, on Friday the FDA approved the "first" non-hormonal medication to treat hot flashes.    The new drug is called Brisdelle.  Its generic name is paroxetine.  That's right.  Paroxetine.  Otherwise known as Paxil.  Paxil was FDA approved for treatment of depression in 1992 and has been generic since 2003.  It is available in 10 mg, 20 mg, and 40 mg tablets.

Brisdelle is a "novel" drug because it is available in a 7.5 mg dosage.  That's right, a whopping 2.5 lower milligrams that generic Paxil.  Is there ANY difference between taking 10 mg of Paxil and 7.5 mg of Brisdelle?  I sincerely doubt it.  I'd stake my medical license on it.

Even the drug company's own research was pretty pathetic.  Per the Times article, women on Brisdelle had an average of 6 fewer hot flashes, while women on placebo had an average of 5 fewer flashes.

Noven Pharmaceuticals has not yet released how much this new wonder drug will cost.  Well, here's a news flash for them.  If it is any higher than $2 a month, they're charging too much.  You can get generic paroxetine 20 mg pills for $4 a month at Walmart.  Break them in half and you've got 10 mg of paroxetine, which is basically what Brisdelle is.

I can't think of any scenario in which I would prescribe this drug.  To me, it appears to be expensive and ineffective.

8 comments:

  1. In my opinion, the use of a psycho-active drug such as paroxetine,an SSRI anti-depressant, for treatment of symptoms caused by menopausal hormone deficiency is an abuse and mistreatment of women belonging in a medical museum as an example of medical iatrogenesis in women.

    Paroxetine, Paxil is medically ineffective for treatment of hot flashes, or any menopausal symptom for that matter, Paroxetine, Paxil is one of the most addictive of the SSRI drugs, with warnings about severe withdrawal effects, loss of libido etc.

    Menopause is a hormone deficiency state and the correct treatment is with hormones identical to those in the human body. Prescribing SSRI antidepressants for menopausal symptoms is a medical practice which should be halted immediately.

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    jeffrey dach md

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  2. Thanks for your comment, Dr. Dach. Although I agree that paroxetine is largely not effective in the treatment of hot flashes, I would take issue with your characterization of it being "addictive." It can have severe withdrawal effects due to its short half-life, but while unpleasant, these withdrawal effects are not dangerous.

    And I've never met anyone who is a paroxetine addict. As I'm sure you know, addiction is characterized by behavior. I'm yet to find anyone who has lied, cheated, or otherwise engaged in maladaptive behavior to get their "fix" of Paxil.

    ReplyDelete
    Replies
    1. Hi Marni,

      Let not quibble over semantics. Paroxetine withdrawal is a bad thing. I wouldn't give these drugs to a dog, so its hard to believe they were approved for human use.


      regards


      jeffrey dach md

      Delete
  3. You wouldn't give Paxil to your dog for treatment of hot flashes or just generally? It's an extremely effective antidepressnant.

    Also, Marni is quite right, addiction is about behaviour, not phsycial withdrawal. If withdrawal is the key, then gambling can't be addictive.

    ReplyDelete
  4. I just saw a commercial for this and I couldn't believe my eyes... "Paroxetine? Um, isn't that just Paxil?" So offensive! I didn't know it was even possible to put a new patent on a dosage. I was annoyed when they re-released Yaz as Beyaz, just adding folate, but this is even worse! I hope people have good doctors who can explain to them why this pill is pointless.

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