FDA Approves a Dangerous New Antidepressant—for Hot Flashes!

July 23, 2013
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antidepressantThe agency defied its own panel’s recommendation against approval because slight benefit is not worth the risk of suicide (and, we might add, addiction).

The FDA has approved the first non-hormonal treatment for hot flashes associated with menopause. The drug is paroxetine mesylate (marketed as Brisdelle). Paroxetine, an SSRI, is the active ingredient in two drugs for depression and other psychiatric disorders, Paxil and Pexeva. Both drugs contain higher doses of paroxetine than the version for hot flashes. The agency’s press release said studies of the drug showed that Brisdelle “reduced hot flashes compared to placebo,” though “the mechanism by which Brisdelle reduces hot flashes is unknown.”

What the press release fails to mention is that the FDA’s Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk-benefit profile of the drug did not support approval—that the benefits over placebo were “minimal,” and that all of the severe side effects associated with SSRIs, such as suicidal thoughts and osteoporosis, outweigh the minor benefits.

The drug’s label features a boxed warning about the increased risk for thoughts of suicide. The label also warns clinicians that it can reduce the effectiveness of the breast cancer drug tamoxifen if taken together, increase the risk for bleeding, and comes with the risk for serotonin syndrome. Fatigue, nausea, and dizziness were the most common side effects. In the 24-week study, there were three cases of suicidal ideation and one suicide attempt among those on paroxetine, all after 12 weeks of treatment. One woman died while on Brisdelle but, according to the company, the death not considered to be related to the drug. Are the risks of taking an SSRI worth it for such an uncomfortable but temporary condition as hot flashes? Especially when we know that these drugs can also be addictive?

It’s highly unusual for the FDA to go against one of its panel’s recommendations, and the agency gave no explanation as to why they did so in this case. We note, however, that 24 million women suffer from hot flashes, and two-thirds of them currently do nothing to treat the condition. This means that the potential untapped market is huge. And FDA seems eager to do the bidding of the pharmaceutical companies.

The reasoning behind taking a non-hormone treatment for hot flashes is to reduce the risk of breast cancer. But this risk has only been studied for synthetic hormone replacement therapy. Bioidentical hormones produced naturally by the body do not involve the same risks—which is why protecting our access to compounded versions of the hormones is so important (as we discussed in our article on the dangerous compounding bill before Congress). Bioidentical estriol does not have known side effects associated with it, while the synthetic versions do.

Besides bioidentical estriol, there are other natural treatments for hot flashes. Dr. Joseph A. Mercola recommends the following:

  • Losing weight (overweight women are far more likely to get hot flashes) with regular exercise and a balanced, lower-carbohydrate diet;
  • Reducing stress;
  • Consuming natural phytoestrogens, which are found in plants like licorice, fermented soybeans, alfalfa, and many others (particularly helpful if they form part of a woman’s diet before menopause);
  • Acupuncture, which is very successful at combating hot flashes and other menopausal symptoms; and
  • Supplementing with black cohosh, an herb that is nearly as effective as estrogen at treating hot flashes, and is also useful in managing the mood swings and irritability that may accompany menopause.

We have wonderful natural treatments available, including bioidentical estriol. An agency that willfully defies its own experts and approves a dangerous drug on which women have already felt like committing suicide—one that is only a minimal improvement over a placebo—is an agency that dances to Big Pharma’s tune.

20 Responses to “FDA Approves a Dangerous New Antidepressant—for Hot Flashes!”

  1. abinico warez says:

    FDA has nothing to do with health nor safety – their primary job is to make sure big pharma is profitable.

       5 likes

  2. WS says:

    I wonder how many women needing relief from hot flashes (and other severe menopausal symptoms) had female organ(s) unnecessarily removed (hysterectomy and/or oophorectomy)? Why not address the gross overuse of these surgeries instead of continually creating and marketing new drugs to try to compensate for the removal of our essential organs which have lifelong, non-reproductive functions (as shown by medical studies)?

    A 2000 study concluded that 76% of hysterectomies don’t meet ACOG criteria – http://www.ncbi.nlm.nih.gov/pubmed/10674580.. Up to 73% of women lose healthy ovaries (the equivalent of a man’s testicles) at the time of hysterectomy. A measley 2% of these surgeries are done for cancer.

    Where has the media been on this issue. The overuse of cardiac stents and open heart surgery has made mainstream headlines but the media is mum on overtreatment in gynecology.

       2 likes

  3. Katherine Potter says:

    I myself have been on an SSRI for years for chronic dunipolar epression which I inherited from a Bipolar Father. I was first on Zoloft which worked well, but had a few mild side effects, so I was tried on Paxil. Within a month I was having serious thoughts of suicide and was considering jumping off the roof of the hospital where I was a medical student. Paxil was a horrible mistake for me, and I went back to Zoloft no longer worried about the mild side effects because I had experienced how truely scary the wrong medicine can be. It has been nearly 20 years since then, and I still remember how that felt, and I have spoken with numerous friends over the years who had a similar reaction to Paxil. I would never recommend this drug to anyone.

       1 likes

  4. Shelly Comerford says:

    Why am I not surprised. Just another governmental agency with too much overreaching power. Even insurance companies are beginning to look at natural remedies as an alternative to synthetic toxic chemicals. It is very sad that the FDA is in Big Pharma’s pocket. At least some people are starting to wake up and pay attention to the harm that prescription drugs are causing.

       10 likes

  5. Alicot says:

    OMG! A shrunk put me on Paxil whenI went through a difficult menopause. She never weaned me when done with menopause and now I amso addicted Ican barely stop. I have to go ultra slow to avoid withdrawal symptoms, but the good news, it is working. The bad news, it will take 5 years to get off this stuff. Beware!!

       3 likes

    • Alkhemist says:

      Try this website to get off antidepressants easily: http://www.theroadback.org

      It worked for me for getting off Cymbalta, which was EXTREMELY difficult otherwise!

         0 likes

    • Dead M3ss3nG3r says:

      Try the natural supplement 5-HTP to help you wean off it. Just research it… it has worked for several People I know.

      I wish you the best in your recovery from this HARMaceutical beast attack in the War on Humanity being carried out by the ruling “elite”…

      Get crucial & health info at NaturalNewsDOTcom & MercolaDOTcom!
      Get world-changing sociopolitical info at InfoWarsDOTcom & GlobalResearchDOTca!
      To escape enslavement we must first be able to perceive the chains that bind us…

      “One person cannot change the world, but one person can spread the message that can change the world.” ~investigative author/speaker David Icke (also get vital news at DavidIckeDOTcom)
      Before automatically dismissing Icke & others like him b/c the data they present so wildly contradicts our conditioned worldview, please remember the words of Albert Einstein when he said, “Condemnation without investigation is the height of ignorance.”

         0 likes

      • Janet Latham, RN, BSN says:

        Watch out for combining 5 HTP with an SSRI. 5HTP is a precursor of serotonin with a molecular size small enough to cross the blood brain barrier. It is a wonderful substitute for SSRI’s which increase the supply of serotonin in your system by preventing the body from taking it up for breakdown and elimination. In short, SSRI’s greatly decrease your ability to get rid of excess serotonin. 5HTP allows your body to easily make more serotonin and can help compensate for a deficiency of serotonin in that way, but leaves the distribution of it and elimination of excess completely under the natural control of your body; hence has far fewer, if any side effects. Sleepiness is often the only side effect that people experience. But you can imagine the difficulties you can get into combining one substance that makes it very easy to create more serotonin with another substance that prevents its breakdown and elimination. It could be very bad! I wouldn’t recommend taking both at once. Find yourself a good naturopath, or possibly a Doctor of Osteopathy to assist you if you can. It might be possible to substitute 5HTP for the Paxil, but this should be done with professional approval and guidance.

           0 likes

  6. Dave Wilber says:

    There is something much bigger and more dangerous than “big pharma” its those who control them! Nobel Laureate Paul Samuelson said the Federal Reserve is an “omnipotent counterfeiter” in his Economics 4th Edition and they said their system “works (us) only with credit” that would keep its value “if there were fewer people bidding against eah other.”–Keeping Our Money (their credit) Healthy. It is common knowledge that the Federal Reserve answers to NO ONE and this was reported in Parade about 1977. What would those omnipotent counterfeiters not do or per- suade us to do to insure the permanence of their omnipotence? Did they tell their Supreme Court to legalize abortion? Did they tell their Congress to subsidize milk, sugar and tobacco, all killers? Being omnipotent, wouldn’t they dictate to the FDA, EPA, NCI, USPHS and to all other agencies? Don’t they determine when we will have wars? When they said their system “works only with credit” do you see their admission that no one pays any taxes since taxes can not be paid with credit and see their admission that our misleaders spend nothing and pay for nothing. Our mis-leaders have no use for money when all of us are risking our lives for weightless credit that God forbids, de.25:13-15. We will have continuous wars as long as soldiers and suppliers pre-tend we are all paid with paper that has not promised payment since 1963 and as long as revenue agents pretend we are all paying taxes with checks that banks won’t offer gold or silver coins to be redeemed. This IS a conquered country and the ten planks of Karl Marx’s Communist Mani-festo have superseded the Bill of Rights. Search: Marx’s ten planks. Taxes are illusions that regu-late consumption. In 1920, economist, John Maynard Keynes wrote: If governments should re-frain from regulation….the worthlessness of the money becomes apparent and the fraud upon the public shall be concealed no longer,:–The Economic Consequences of The Peace. My people perish for lack of knowledge, Hosea 4:6

       2 likes

    • Dead M3ss3nG3r says:

      Indeed, you are on the right track. People should REALLY listen to Alex Jones at InfoWarsDOTcom,

      “One person cannot change the world, but one person can spread the message that can change the world.” ~investigative author/speaker David Icke (also get vital news at DavidIckeDOTcom)
      Before automatically dismissing Icke & others like him b/c the data they present so wildly contradicts our conditioned worldview, please remember the words of Albert Einstein when he said, “Condemnation without investigation is the height of ignorance.”

         2 likes

  7. Ted Treanor says:

    Wondering when is the US Attorney General going to investigate the FDA for conflicts of interest, and their hiring practices, and decisions that don’t appear to serve the greater good of ordinary people? The credibility of the US Goverment worldwide is at stake.

       2 likes

  8. Helen M says:

    I find it is more and more a case of follow the money, something that makes me uncomfortable whenever I have to treat a condition. Is the medication safe? Do I really need this? And on and on, particularly since many of my problems stem back to medications and doctor error.

       1 likes

  9. Jana Hill says:

    Psychiatric drugs including SSRI’s are of questionable help and may cause other health problems, agreed. However, a compulsion to continue using the drug in spite of its known negative consequences ( addiction )I s not among them.

    Being made sick by a drug is not addiction. Being physically dependent on the drug because the drug impaired normal physiological function is not addiction. Yet here you say:’Are the risks of taking an SSRI worth it for such an uncomfortable but temporary condition as hot flashes? Especially when we know that these drugs can also be addictive?

    You mean physically dependent until the drug is properly tapered. You don’t mean to accuse victims of bad prescribing of being addicts. do you?

       0 likes

  10. Tracey Libby says:

    I have long been concerned about Western medicine’s tendency to automatically prescribe a pill for any given condition versus first educating a patient about making important life-style changes. Unless it’s a life-threatening situation, medication, surgery, and other procedures should be a last resort.

    As a licensed mental health counselor, I find it frustrating when prescribers have placed a client on an SSRI and/or other psychotropic drugs without encouraging counseling and life-style changes to help manage their condition. These drugs can be potentially life-saving for some with severe major depressive episodes and can also help to manage dangerous psychotic symptoms in others. At times, they can also be useful for the short term in helping someone to get to a point where they can better focus on developing coping strategies. Ultimately, changing the way one thinks and behaves and learning other coping strategies provide the best outcomes for many mental disorders. I feel it’s important to educate my clients about both the risks and any potential benefits of these medications so that they can make the best informed decision for themselves. While I may or may not completely agree with the decision, I will respect it.

    I applaud your effort to educate us about the misinformation that surrounds natural treatments, as well as that around prescription drugs. As you mentioned, there are serious risks that come with these (and most) medications. However, you were incorrect in stating that addiction is a risk of using SSRIs. It is possible to become physically dependent upon these drugs, resulting in withdrawal symptoms if not appropriately weaned. It is also possible to build a tolerance to these drugs, resulting in the need for a higher dose in order to be effective. However, tolerance and dependence alone do not constitute addiction. Addiction is a biological brain disease which results in a desire for the drug despite harmful consequences to a person’s health, relationships, and employment activities. While tolerance and dependence are part of the DSM-IV criteria for a diagnosis of substance dependence (i.e. addiction), they do not constitute addiction by themselves. To indicate otherwise does a huge disservice to people taking drugs that have no addictive properties (such as the SSRIs) as well as to those who take drugs for pain, yet who do so exactly as prescribed and have no risk factors for addiction.

    For the full criteria of addiction…

       1 likes

  11. Elizabeth says:

    I suppose that the patent on Paxil expired and GSK needed a new reason to re-introduce the drug. Lilly did this same thing in 2001 when it introduced Sarafem aka Prozac to the market for the treatment of Premenstrual Syndrome. There were actually women taking Prozac for depression and Sarafem for PMS, not realizing they were the same medication!

    My OBGYN told me that she would never prescribe Paxil for hot flashes because it was too dangerous and risky but she was willing to prescribe Effexor and Zoloft. ???? It’s obvious she majored in Medicine and not Logic.

    Big Pharma is always attempting to turn any ‘ uncomfortable’ condition into a disease that warrants medication. Who can blame them? They are legal drug pushers and dealers. I just wish they didn’t have any customers.

       2 likes

  12. Lil Robertson says:

    Homeopathy works great for hot flashes. I took two doses of a homeopathic remedy that is used for hot flashes and never had the problem again. The remedy that I took was Lachesis. I had studied homeopathy for some time and knew how to use it. A person trained in homeopathy could help with this problem.

       2 likes

  13. Searching for answers says:

    What does the FDA care about suicide risk?

    Just read the first few chapters of the book “Pharmageddon” by Dr David Healy, and you will find the FDA does not care one whit about drugs that promote thoughts of suicide, in young or older folks alike. After all, they get paid for approving drugs, not for rejecting them.

    Just wait a few years and this too will need to be yanked off the market…like so many others this century.

       2 likes

  14. Betty Rinderknecht says:

    There are non toxic ways to cool off when experiencing a hot flash. I have lived through many hot flashes. You can turn on a fan, go outside on the porch for a few minutes in winter, wash your face with a cloth wetted with cold water. Shrug and laugh and say it won’t be forever. Thoughts of suicide and actually attempting suicide while doing the preliminary tests should be enough to nix approval. But the FDA is getting as bad as the IRS and NSA in its actions. Time for some real scrutiny of this FDA bunch.

       3 likes

  15. Wendy says:

    It would be completely irresponsible to get menopausal women hooked on paroxetine. It’s miracle drug for a certain type of disorder, but a person can’t get off it, and it wrecks havoc on one’s inhibitions. If you are overly inhibited, a worrier, and socially phobic, it can save your life. If not though, it’ll make you an alcoholic risk taker and muddy your thinking. Maybe at the lower doses in this new pill it won’t be too dangerous, but I wouldn’t touch it with a 10 foot pole. How come drug makers don’t worry more about lawsuits?

       2 likes

    • Dead M3ss3nG3r says:

      B/c they are making enough money to cover the few lawsuits that make it through the beast system that the HARMaceutical-industrial complex is a tentacle of.

      Get CRUCIAL, world changing news at InfoWarsDOTcom, NaturalNewsDOTcom & GlobalResearchDOTca!

      “One person cannot change the world, but one person can spread the message that can change the world.” ~investigative author/speaker David Icke (also get vital news at DavidIckeDOTcom)
      Before automatically dismissing Icke & others like him b/c the data they present so wildly contradicts our conditioned worldview, please remember the words of Albert Einstein when he said, “Condemnation without investigation is the height of ignorance.”

         0 likes

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