On June 28, 2013 the FDA announced its approval of Brisdelle (paroxetine) “to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause.”

In its news release about Brisdelle, the FDA has emphasized that this is “the only non-hormonal treatment for hot flashes approved by the FDA.” The agency hinted that estrogen alone or estrogen plus progestin may have a downside and that “a significant number of women who suffer from hot flashes associated with menopause…cannot or do not want to use hormone treatments.”

We’re not surprised that this message about a non-hormonal approach to hot flashes would be very appealing. Baby boomers are entering menopause in huge numbers and many have read scary stories about the risk of breast cancer associated with hormone replacement therapy (HRT), not to mention blood clots that could cause heart attacks or strokes. But what are the pros and cons of paroxetine?

The Straight & Skinny on SSRIs for Hot Flashes

So what’s the story behind the headlines regarding paroxetine for hot flashes? In case you are unfamiliar with paroxetine, it was originally approved by the FDA for treating depression under the brand name Paxil in 1992. This medication is in the same category as fluoxetine (Prozac) and sertraline (Zoloft). They are all selective serotonin reuptake inhibitors (SSRIs). In other words, they affect the neurochemical serotonin in the brain.

All three of these antidepressants have been widely prescribed for a variety of psychological conditions including depression, panic, social anxiety and obsessive-compulsive disorder. Doctors also prescribe these medications for PTSD (posttraumatic stress disorder) and bad PMS symptoms called premenstrual dysphoric disorder.

The effectiveness of SSRIs for easing depressive symptoms has been controversial. A meta-analysis published in 2010 found that the medications can be helpful for people with very severe depression of long standing. But for those with mild to moderate depression (which represent the majority of prescriptions), the drugs are hardly better than placebo (Journal of the American Medical Association, Jan. 6, 2010).

How Good is Brisdelle at relieving hot flashes?

The FDA is rather cagey about the benefits of this new drug. Here’s their official statemement:

 “The safety and effectiveness of Brisdelle were established in two randomized, double-blind, placebo-controlled studies in a total of 1,175 postmenopausal women with moderate to severe hot flashes (a minimum of seven to eight per day or 50-60 per week). The treatment period lasted 12 weeks in one study and 24 weeks in the other study. The results showed that Brisdelle reduced hot flashes compared to placebo. The mechanism by which Brisdelle reduces hot flashes is unknown.”

Sounds pretty good, right? Well, as the saying goes, the devil is in the details. The FDA has not told you HOW much better Brisdelle is compared to placebo. All the feds says is “reduced hot flashes compared to placebo.” Would you like a peek behind the official FDA statement?

Mary Carol Jennings, MD, testified at the FDA’s Advisory Committee hearings on the benefits and risks of paroxetine for hot flashes. She was speaking on behalf of The National Research Center for Women & Families, a nonprofit research center that does not accept money from drug companies. We encourage you to read her full statement at this link. Here is the bottom line from her testimony:

“As the FDA has clearly stated in their memo to you, the company reported a significant reduction of the frequency of hot flashes at week 4 but only in one study at week 12.  And, one of the studies did NOT show a significant reduction in severity of hot flashes through week 12.

“What are the risks?  FDA notes that the greatest risk is depression and suicide.  Although women with a history of depression or suicidal thoughts were excluded from this study, the data clearly show that the women taking paroxetine were more likely to have suicidal thoughts and behaviors than the women taking placebo. This was true even on the small dose of 7.5 mg.”

The FDA’s own Advisory Committee of outside experts voted against approval of this drug for hot flashes. That is a rare event. In answer to one of the questions posed to the committee: “Is the overall risk benefit profile of paroxetine acceptable to support approval of the product for VMS  [vasomotor symptoms or hot flashes]?” the vote was 4 to approve and 10 not to approve. Despite the vote, the FDA execs chose to overrule the outside experts and move forward with approval.

Then there are the side effects. The FDA mentions in its official news release on Brisdelle that the most common side effects are headache, fatigue, and nausea/vomiting. There is also a boxed warning about suicidality. The official prescribing information includes warnings about abnormal bleeding, low sodium levels (hyponatremia), bone fracture, seizures, an “inner sense of restlessness and agitation” (akathisia), glaucoma and impaired judgment, thinking or motor skills.

Admittedly, the dose of Brisdelle is lower than the usual antidepressant dose of Paxil and therefore other side effects may be uncommon for this drug. Nevertheless, we thought you might want to know about side effects reported for this class of medications in general.

SSRI Side Effects

  • Nausea, stomach pain, constipation, diarrhea, decreased appetite, vomiting
, loss of appetite
  • Sexual dysfunction, lowered libido, [erection difficulties, abnormal ejaculation], lack of orgasm

  • Weakness, fatigue, lack of energy, sleepiness
  • Dizziness
  • Dry mouth
  • Sweating
  • Blurred vision, visual disturbances
  • Headache
  • Tremor, anxiety, insomnia
  • Liver damage
  • 
Serious skin reactions, rash, hives (requires immediate MD assistance!)

  • Glaucoma

  • Irregular heart rhythms

  • Bleeding problems

  • Blood pressure problems
, low blood sugar, low blood sodium
  • Interaction with other drugs (leading to serotonin syndrome, among other reactions)

  • Pneumonia
, pulmonary fibrosis
  • Seizures

  • Depressed mood, suicidal thoughts and behavior, suicide

Such a long list of side effects makes your eyes glaze over after the top 3 or 4. Drug companies count on this space-out effect, which is why they often create long paragraphs of side effects that people give up on after one or two lines. But even in lower doses (Brisdelle is dosed at 7.5 mg at bedtime compared to a starting dose of 12.5 mg for Paxil to treat depression), there could well be side effects for some women.

Then there is “sudden discontinuation syndrome,” or stopping such medications. One visitor to our website said that antidepressant withdrawal feels like circles of hell.”  The maker of Brisdelle admits that: “Certain symptoms were seen more frequently in women at the time of discontinuation of BRISDELLE compared to women discontinuing placebo, and have also been reported upon discontinuation of other formulations of paroxetine, particularly when abrupt.”

SSRI Withdrawal Symptoms:

  •  Brain “zaps” (electric shock-like senstations in the brain)


  • Dizziness, light-headedness, vertigo, feeling faint


  • Headaches


  • Anxiety, irritability, hostility


  • Nausea, diarrhea, digestive upset


  • Tremor, hands shaking, nerve tingles, strange sensations


  • Fatigue, tiredness, lack of energy


  • Visual disturbances



Again, a list of symptoms does not do this problem justice. To read stories from people who have gone through this experience you may find these two links worthwhile:

• Link 1

• Link 2

Should you wish to learn more about dealing with hot flashes or menopausal symptoms through some other strategies, we offer our Guide to Menopause. We would love to get your thoughts about Brisdelle. Do you think it is worthwhile? Would you take it? What more would you like to know about menopausal symtpoms and non-drug approches to hot flashes? What has worked for you?

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  1. Ella
    Illinois
    Reply

    Hey ladies please talk to your doctor about your thyroid. I had a hysterectomy and I probably am going through menopause, I got my thyroid tested and it came up normal but just like you ladies I started experiencing horrible anxiety and hot flashes and I was getting fat and old looking. I started taking iodine and I swear I look and feel younger. Try a small doses of iodine but ask your doctor first. I didn’t consult my doctor because I’m afraid she might discourage me, but it worked for me. Look up thyroid disease or iodine deficiencies. I take very small drops in my coffee and it changed my world.

  2. ann
    KY
    Reply

    My Dr. put me on Brisdelle for severe hot flashes. It helped so much but with the cost I decided to go off of it. I had no clue it had Effexor in it. I was told it’s for hot flashes! The withdrawls were awful, cried constantly, moody, just a mess so I went back on it and now have no idea how to wean off of it.

  3. Lynne
    Northern California
    Reply

    I am a 61 year old post menopausal woman who has taken Paxil to treat depression for about 25 years. I have tried to discontinue this drug several times due to its sexual side effects. I never experienced hot flashes or night sweats as I passed through menopause until I stopped taking the Paxil. Then, oh boy, did they come on with a vengance! I anandoned each attempt to discontinue the Paxil because I never could sick it up enough to make it through the “Paxil flu”. Sure enough, the hot flashes and night sweats disappeared once I went back on the Paxil. So, YES, in my case paroxetine did indeed mask the symptoms of menopause.

  4. Dee
    Atlantic City NJ
    Reply

    Brisdelle was a godsend for me. I suffered 5 years with horrendous hot flashes and sleepless nights with the night sweats. I was irritable and wanted to eat my pets (j/k but practically ).

    I dont have insurance and was given Brisdelle by a friend . She stopped taking it because it caused her to gain weight. I DID NOT CARE IF IT CAUSED ME TO GROW ANOTHER ARM, I needed relieve before i seriously hurt someone.

    It took 3 weeks to take effect, I’ve been on Brisdelle now for 4 months and I love it. I have experienced no side effects, no weight gain. I’m back to my happy, fun , peaceful self I loved and missed pre-menopausal.

    • Terry Graedon
      Reply

      We’d be remiss if we failed to note that taking somebody else’s prescription could cause problems!

  5. Annie
    Virginia
    Reply

    I’ve been taking Brisdelle 7.5 mg every night for a year now, for my severe hot flashes (10 per day). At first, this drug worked very well. It didn’t eliminate the hot flashes completely but it definitely decreased the number and severity of them, especially at night. Well, now it seems to have stopped working. The past several months my hot flashes have returned and so I’m going off this medication because I hate taking pills anyway. Why take them if they don’t work?? I’m weaning off instead of stopping abruptly to hopefully minimize the terrible withdrawal symptoms I’ve read about. Wish me luck.

  6. Pat
    California
    Reply

    I am an 85 year old woman and breast cancer survivor of 12 years. I have Hot flashes and chills all day and evening plus internal shakes and unsteadiness, which my GYN prescribed Brisdelle, 7.5 mg. I purchased a month supply a high price, and then read the side effects. I’m on numerous meds and am afraid to try the new prescription. Anyone else in my age group with the same back ground, with any comments?

    • Michele
      Reply

      Did weaning off Brisdelle 7.5mg slowly help you with side effects of going off?

  7. Val
    AR
    Reply

    My only complaint with Brisdelle is weight gain. I am a very active person, teach workout classes and eat right. It has been disheartening for me to be an exercise coach who is gaining weight!! I can’t wear any of my cute clothes anymore. I have resorted to wearing yoga pants and stretchy jeans with long tops over them to cover my butt. On the upside, my hot flashes are GONE, I am now sleeping ALL NIGHT, and I can POOP without a laxative, something I have been unable to do since 2011. It is indeed a trade off….. I am getting ready for vacation however and am already depressed knowing that none of my cute dresses fit. I have not had to go up to “double digits” in clothing size since I was pregnant with twins and I do not want to have to do that now. :(

  8. Melanie
    Dallas
    Reply

    I was just given Brisdelle by my doctor, not for hot flashes per se (although I’ve dealt with them for ten years) but just for something to calm me down so I could focus better and get stuff done. I figured if it helped with hot flashes, all the better.
    Early on, I noticed I woke up not feeling exhausted and irritable, like I usually do. Yah! But by week two, I’m having trouble falling alseep and staying asleep. I toss and turn all night. And this medicine has done absolutely nothing for my hot flashes!
    I’ve never had problems sleeping and not being able to now is worse than dealing with hot flashes.
    And as others here have mentioned, the 7.5mg ($35) does not come in generic but the 10 and above does & it’s only $5. Gotta love big pharma! I’m SO done with this stuff!

  9. Lori
    Arizona
    Reply

    I specifically asked my doctor about weight gain with this drug. She said no, however have gained 5 pounds in the two months of taking Brisdelle. That was enough for me! I am stepping myself down to go off this medication. Know that it did work, my night sweats reduced significantly. Personally, the weight and my self image is more important that the night sweats. I will seek out other therapies.

  10. Epp
    California
    Reply

    What!!!?
    Check these Walmart prices for paroxetine…
    20 mg 30 pills (Paxil) $4.00 with coupon
    7.5 mg 30 pills (Brisdelle) $174.38 with coupon
    How can this be justified?

  11. Shelley
    The Mighty Midwest
    Reply

    Let me just add – that I’m a migraine sufferer – Haven’t had a headache since June – first time ever!!! And then – I started the estrogen that my doctor wanted me on. 3 days of hell. And to think I only have 3 weeks max left of the Brisdelle. I don’t have the energy to call everyone to make this right. It’s infuriating. For real.

  12. Shelley
    Morrison, IL
    Reply

    Welp – I am 52…and was having horrific hot flashes only at night. OMG..the sweats were terrible and I woke up every hour. Then I found Brisdelle. What a freakin’ godsend – until I went to go pick up a prescription of it yesterday. SS rejected it. My doc had been giving me samples. HOLY CRAP – It’s 300 bucks here and if you are on SS – you can’t take advantage of the 25.00 coupon. How much sense does it make that you can clearly not be well and the script is one price – but if you are privately insured – it’s 25 bucks. This is so wrong on so many levels. I just want to die now. I cannot imagine going backwards. This just sucks. Big Time.

    • Lynne
      Northern California
      Reply

      Ask for Paxil instead of Brisdell and use a pill cutter to make smaller doses. Paxil Is DIRT CHEAP, and it is the same thing. It just comes in higher doses than Brisdell

  13. Tina
    South Carolina
    Reply

    This drug is Paxil. You DO NOT want to take this medication. It causes significant weight gain and HORRIBLE withdrawal symptoms that will probably be much worse than the symptoms you are taking it for. Do your research.

  14. Deborah
    Springfield, Missouri
    Reply

    Ladies, I, too had moderate to severe hot flashes and tried HRT which worked well but had to stop because of the risks. I went back to my misery of hot flashes of 8 to 10 a day and all through the night. Wasn’t sleeping, wasn’t happy, moody, tired. I finally broke down and went to my doc and he put me on low dose of Effexor and I feel sooo much better! I sleep through the night now, flashes are lessened to 1 or 2 a day, I’m happier and moods leveled out. So happy I decided to try it. Small side effects in the beginning but benefits outweigh them! Plus, it’s not expensive if you get the generic.

    • Tina
      Reply

      Be careful when you go to stop taking the Effexor. You may have to wean off of it or the symptoms could return with a vengeance.

  15. Sherry
    North Carolina
    Reply

    I have been on Brisdelle for 6 days and I am beginning to wonder if I should stay on it. I see only a small difference in my night sweats and hot flashes. My question is, does is get better the longer on stay on Brisdelle or should I already be seeing a huge difference?

  16. Freddie
    Tennessee
    Reply

    I am 54 years old and I have experienced the extreme form of hot flashes for 3 years. That is, I experience what I fondly refer to as projectile sweating hot flashes about 7 to 10 times a day, every day, for 3 years – no break. I am normal body weight and run about 2 to 3 miles a day, 5 days a week. I eat well, drink lots of water, blah, blah, blah. I tried Estroven for a few days and did not notice any changes (I actually thought it got a little worse). Last November my doctor gave me 6 weeks of Brisdelle. The very night I took Brisdelle I stopped sweating and that next day I definitely sweat less profusely (think light rain) and less often. For the next 6 weeks I noticed a gradual lessening of sweating and almost forgot I was going through menopause. When the 6 week samples were out at the end of December, I chose NOT to get a refill. I seemed fine but have noticed that very, very gradually, the flashes are increasing in number and intensity. I went back on Brisdelle yesterday and I can’t tell a difference yet. I have not noticed any negative side effects while on the drug or off it. Knock on wood. :)

    • Shari
      California
      Reply

      I am 54 (breast cancer survivor) and had the same kind of soaking sweats as you. Brisdelle has worked wonders! I have been on it a couple of months and I love it! However, I have noticed that I’ve had a lot of diarrhea. (Maybe that’s why no weight gain.) Personally, I’d rather have diarrhea than gushing sweats every hour. I have missed a day or two here and there and have not noticed any adverse reaction. I have the $25 coupon so it’s been very affordable. I will probably continue for a while.

  17. Denise
    Florida
    Reply

    I had been on Venlafaxine 37.5 mg for about 10 months. It worked great, absolutely no flashes or sweats, then out of nowhere it stopped working. The flashes and sweats were back with a vengeance! I am on bio identical progesterone, but can’t do the bio identical estrogen because I am still producing estrogen (I’m peri menapuasal). Before the Venlafaxine I tried Celexa for 6 months, which killed my appetite and I had a constant inner restless/anxious feeling, but absolutely no flashes or sweats. At 50, I am still fighting to gain and maintain weight (quite the opposite of most people), so Celexa had to go, at 107 lbs I looked like a skeleton. I was excited to hear about Brisdelle, but knowing it’s a SSRI I didn’t want to take the chance of going through the same thing as the Celexa. The sweats and flashes are so bad I finally broke down. Yes the Brisdelle is ridiculously expensive even with insurance, it is the EXACT same thing as Paroxitine, just a different salt which may or may not affect the way it is released into the body (Paroxitine HCL = Paxil, Paroxitine Mesalayte= Brisdelle). I had my doctor write a script for Paroxitine HCL 10mg and break them in half to get started. Been on it for 3 days now, first 2 days had severe headache and nausea, un relievable even with 800mg of Motrin, very tired, and annoying to no end ‘brain zaps’ Had to have doctor call in Zofran for the nausea which worked. 3rd morning, headache less severe, no nausea, decreased brain zaps (but still present). I am going to stick this out at 5mg and hope for the best. If side effects go away and it works for the flashes and sweats (which I continue to have), I will increase it to the whole pill (10mg). The difference between Brisdelle at 7.5 mg and Paroxitine HCL at 10mg is practically nothing, might even help with the mood swings. Otherwise it’s back to the Venlafaxin, maybe just needed a “medication holiday”.

  18. Lorene
    United States
    Reply

    I am in my 11th year of severe hot flashes, usually hourly 24 hrs a day. I tried cohash, acupuncture with two different practitioners, herbs and finally effexor with ambian to sleep. Last month I went off effexor to the horrors of detox and the return full force of hot flashes. I am back on it. It is hard to think I may be on it for the rest of my life but having to change clothes several times a day and interrupted sleep is worse

  19. Nancy
    Tucson
    Reply

    I was having 10 to 12 hot flashes (I call mine slow-burns) a day. This was in Tucson in the summer with temperatures in the 90’s or higher. Breast cancer runs in my family so no hormones for me. It took me a little over 2 months to completely end the slow-burns. I’ve had a couple in the following months but nowhere near what they were before. Placebo or the real thing it’s working for me so I’m sticking with it for now. Also go the Brisdelle web site. You’ll get a card to give to your Pharmacist and pay $25 for each prescription after that.

  20. Debbie M.
    PA
    Reply

    Brisdelle has been a Godsend to me. I was having 6 -8 severe hot flashes per day and now I have none. The surprising positive effect on my Raynauds was incredible. I had no idea that it would help my hands. This was an added benefit of the drug that I didn’t know about. As a school teacher, the combination of the hot flashes and Raynauds made teaching such a challenge. I feel better than I have in 2 years. My only problem is that my insurance company doesn’t want to cover it. Is there a drug close to Brisdelle, such as Paxil? Is the dosage of paroxetine the same? Thank you.

    • The People's Pharmacy
      Reply

      Ask your doctor to prescribe 7.5 mg of paroxetine. That is the dose of Brisdelle.

  21. Christine
    LIncoln NE
    Reply

    I tried Brisdelle after having to disontinue HRT due to a Transient Ischemic attack… or a stroke. I am fine, very lucky, but the hot flashes and night sweats are preventing good sleep now. My gynocologist gave me a month of Brisdelle samples. I seemed to tolerate it well with a few side effects. I had the best night sweats control after a few weeks. But now I seem to be gaining weight, and that isn’t going to help anything. Now that my samples are gone, I’m going to try to tough it out and see if they will level off after my body is done freaking out without hormones. Terrible choices, misery or stroke?

  22. MissyS
    Reply

    Sounds like the only reason they created a “new” drug was because the old one has a generic version.

    If you can’t afford Brisdelle, which is paroxetine, why not just take paroxetine and cut the tablets into 7.5 mg pieces? The generic paroxetine is about $10 a prescription.

    I’ve take Paxil/paroxetine for depression the past 20 years and haven’t had significant side effects. It is hard to get off of, but so is depression. I’d rather not be depressed.

    • Claudia
      EL Paso, TX
      Reply

      The voice of reason. Thank you for sound advice.
      I don’t believe they make paroxentine 7.5, but they make 10mg. You have to split it, and yes it is less than $10 for 30 days.

  23. Amy
    Santee, SC
    Reply

    I saw a commercial for Brisdelle and was interested in knowing more since I have struggled with hot flashes and night sweats for way too long. That is until I learned it was same as Paxil. I took Paxil some years ago and the withdrawal symptoms were horrific. I suffered the “brain zaps” others report and it was one of the worst things I ever went through. My family doctor refused to write prescriptions for Paxil as he had patients who were women who worked in his office and they had a heck of a time weaning off the drug. I know there are people who have been helped by Paxil, and that’s their business. But for me, you couldn’t get me anywhere near Brisdelle, knowing it is the same drug.

  24. nikki
    boston
    Reply

    I am 46 and it seemed like overnight I developed hot flashes, I counted one day and it was close to 2 and hour. Even when I work out I don’t “sweat” I perspire, but with theses flashes I am dripping. Actual sweat dripping down my face. My clothes get sweat marks on them. I work with the public, so having sweat stains appear on your clothing is not a good thing. I think I have wasted a small fortune trying every herbal remedy out there! I am not one to run to the Doctor, in fact, it had been over 5 years since I went for my last physical before this event. I exercise 4-5 times a week, if anything I am a few pounds under weight, I drink a ridiculous amount of water , don’t smoke, don’t drink and eat fairly healthy.

    Finally broke down and went to Doctor. She first tried me on Estovera. I was so excited, thinking that I would finally get some relief. I got nothing. Yesterday she prescribed Brisdelle. When I tried to pick it up at the pharmacy I was told they wanted a pre-auth and that there was no generic. The Pharmacist went on to say that they probably wouldn’t approve it and it would be $178! Seriously!?? So, what are my options? Try HRT? I cant do anything else physically to help. I spend most nights awake either sweating or absolutely freezing. I don’t do well without 8 hours of sleep. I also have a short fuse to begin with so this is NOT helping. Some days I really want to take a bat to someone lol! Crossing my fingers that I can at least try this RX without shelling out $200!

    • Dee
      Plano TX
      Reply

      Nikki – go to Brizdelle’s website. They offer a coupon type deal for $25 a prescription. It sure helped me. No more hot flashes and I’m on month 3. Bad side effects initially, but they have wained. Gained 5 lbs.

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