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New FDA Drug Approval: Blessing or Boondoggle?

New FDA Drug Approval: Blessing or Boondoggle?

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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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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