Here’s a list of compiled links providing information on Pristiq. These links include info from my blog and others.
Pristiq's side effects: Too close to Premarin and Prempro for comfort?
Back in January 2007, I’d mentioned that Wyeth was not only seeking to market Pristiq (desvenlafaxine) for depression but also for the use of vasomotor symptoms in menopausal women.
I just learned that Wyeth produces two major menopause drugs, Premarin and Prempro, that allegedly has produced hormones causing cancer in more than 5,000 women. This added up to a loss of 40 million users and $1 billion annually.
With Effexor going generic in 2 years and the introduction of Pristiq to the market, Wyeth hopes to lure some of those customers back and net an annual $2 billion. However, serious questions linger about Pristiq’s side effects in menopausal women.
Why did two women in the study group taking Pristiq have heart attacks
and three need procedures to repair clogged arteries compared with none
taking placebo? How can Wyeth assure long term safety when 604 of the
2,158 test subjects took Pristiq for only six months and 318 for a year
or more? And what about serious liver complications seen in the studies?
Martha Rosenberg, reporting on Pristiq’s use as a menopausal drug, culled comments from CafePharma’s message boards and found one thread rife with mixed comments on the new drug. From an Anonymous commenter:
Continue reading “Pristiq's side effects: Too close to Premarin and Prempro for comfort?”
I hate to brag, but…
I hate to brag, but…
February 28, 2007
Pristiq's FDA Chances: Depression – Yea; Menopause – Nay
It wouldn't surprise me if they said yea to antidepressant use and nay to vasomotor use because of lack of evidence in improved symptoms.
April 19, 2007
Wyeth looking for Pristiq's FDA approval in 2008
I'll follow Pristiq as the information continues to trickle out but don't expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.
This is one of the few times I can actually say I was right. (Teenage-like "squee!" goes here.)
More recent posts from:
Loose Screws Mental Health News
Advance apologies for sounding like I’m in a cynical mood. I’m working on something today that I’m not fond of.
An article in Newsday (by the Associated Press) says that researchers are becoming hopeful that hormonal therapy can ward off mental health decline in menopausal women, such as dementia. It seems that previous research found that hormonal therapy produced negative results, but the new research suggests that timing may be the defining factor. Older women in the later stages of menopause seem to be at more risk for heart attacks, strokes, and breast cancer. Doctors are saying hormone therapy may work in women in the earliest stages of menopause.
The Long and Short of It
- Researchers have discovered that the malfunction of a gene thought to be associated with schizophrenia or depression seems to have symptoms associated with those illnesses. They figured it out thanks to our trusty mice. The mutated gene is called DISC1 (Disrupted in schizophrenia 1).
- Breast-feeding helps new moms battle depression. Consuming foods with omega-3 fatty acids also provides benefits. According to an author named Kathleen Kendall-Tackett, breast-feeding lowers stress levels. However, if the mother is having issues feeding her child, it can have the opposite effect and bring on depression.
- Walter Cronkite’s daughter Kathy has a book, The Edge of Darkness, which details her battle with depression. Oh, and by the way, Joan Rivers and Mike Wallace deal with depression too. (That’s in the book.) EDIT: Polly of polarcoaster.net let me know that Cronkite’s book isn’t new. She was just discussing her experience with depression in Cincinnati’s The Enquirer.
- A new study shows that chronic depression may lead to diabetes in older people.
“The culprit appears to cortisol, a hormone produced in response to stress. When someone is depressed, cortisol levels rise. If depression is chronic, cortisol levels may stay consistently high.” – Debra Manzella, R.N.
Also, make sure you’re working on your 300+ crunches daily:
“Excess belly fat is a known risk factor for diabetes.”
Women & Antidepressants
Pink, a magazine for business women, has an article in its April/May 2007 issue titled, “The Magic Pill.” (The only way to read this article is to get a hard-copy of the mag.) No, this isn’t about birth control. The subhead: “Antidepressants are now used for everything from migraines to menopause. But are women getting an overdose?”
Good question. The article, well-written by Mary Anne Dunkin, does a nice job of trying to present both sides of the coin. One subject, Pam Gilchrist, takes tricyclic antidepressants to relieve her fibromyalgia symptoms. “One of the [antidepressants] that allows her to keep going” is Effexor (venlafaxine). God forbid the woman should ever have to come off of that one. (It works well when you’re on it, but withdrawal is sheer hell.)
The other subject mentioned in the article, Billie Wickstrom, suffers from bipolar disorder, but had a therapist who diagnosed her with obsessive-compulsive disorder. The psychiatrist she was referred to promptly put her on Anafranil (clomipramine). We all know what antidepressants tend to do for those with bipolar disorder. Wickstrom blanked out at an interview that she says she normally would have aced. In another incident, she veered off-course after leaving town and spent the night on the side of the road with her daughter. “Search parties in three states” were out looking for them.
“Three years and three hospitalizations later, Wickstrom is finally free of clomipramine and has a job she loves as PR director for a $300 million family of companies. She says she’s happy, she’s focused and she feels great – consistently.”
Dunkin’s article uncovers a large, problematic use – by my standards, anyway – of off-label usage by doctors.
“Gilchrist… is one of the estimated one in 10 American women taking some type of antidepressant medication. And a considerable percentage of these prescriptions, particularly those for tricyclic antidepressants, are not used to treat depression at all.
A growing number of doctors today prescribe antidepressants for a wide range of problems, including anxiety, chronic pain, insomnia, migraines, high blood pressure, irritable bowel syndrome, premenstrual syndrome, menopausal hot flashes and smoking cessation.”
I’m sure the list goes on, but magazines have but oh so much space.
Dr. Melissa McNeil at the University of Pittsburgh points out three things:
- Since depression is a prevalent (see common) condition, doctors are better detecting it.
- Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
- Clinical studies are finding that antidepressants can aid a number of medical issues apart from depression.
My take on McNeil’s points (I’ll try to keep them brief):
- Depression is way too common to be abnormal. If a woman has a rough patch in life for 2 weeks or more, she’s got depression. As for doctors being better at detecting depression? Studies consistently show that doctors are great at overlooking depression in men.
- Antidepressants haven’t proven jack squat. Placebos have proven more safety and efficacy than antidepressants. PCPs have no reservations prescribing them because they only know about the positive facts that pharma reps tell them instead of researching the potential side effects.
- Clinical studies aren’t finding all those things out. Seroquel has FDA-approval to treat psychiatric symptoms (psychosis, for one). As far as I know, Seroquel is not FDA-approved to treat insomnia or crappy sleeping patterns. There are no specific clinical studies to see if Seroquel can treat insomnia. Seroquel is prescribed to treat insomnia/restless sleep because doctors have found that a major side effect of the drug is somnolence. If this is the case, Effexor should be prescribed for weight loss. It’d be the new Fen-Phen.
Dunkin cites two widely used antidepressants for nonpsychiatric uses: Wellbutrin (bupropion) and Prozac (fluoxetine). Zyban, used for smoking cessation is, well, bupropion. Sarafem, used to treat PMS symptoms is – you guessed it – fluoxetine.
Dr. Viktor Bouquette of Progressive Medical Group thankfully takes a more cautious approach:
“The widespread use – mostly misuse – by physicians of antidepressants to treat women for far-ranging symptoms from insomnia, chronic fatigue and irritability to PMS and menopause is merely another unfortunate example of the pharmaceutical industry’s tremendous influence on the practice of modern medicine. Take enough antidepressants and you may likely still have the symptoms, but you won’t care.”
Kudos to Dunkin for landing that quote. Since Bouquette is part of an alternative medicine group, he’s got a good motive for slamming pharma companies.
McNeil goes on to sound anti-d happy in the article. Not that it matters, but she is also a section editor for the Journal of Women’s Health, which has several corporate associates representing pharmaceutical companies. (She is also the only source in the article who sings anti-d’s praises.) Dunkin tracked down Dr. Scott Haltzman, a clinical professor at the Brown University Department of Psychiatry, who advocated patient responsibility.
“Just because antidepressants work for depression does not mean they should always be used. People need to learn skills to manage their depressive symptoms instead of depending on medication. When you take medicine for every complaint, you lose the opportunity to learn how to regulate your mood on your own.”
Oh, for more doctors like Haltzman and Bouquette.
UPDATE: Uh, alleged fraud suit pending against Progressive Medical Group. Bouquette is now part of Progressive Medical Centers of America.
Pristiq's under-the-radar clinical trials
News stories on Wyeth’s Pristiq, Effexor’s “knockoff”, have focused on the drug’s uses that are pending FDA-approval: vasomotor symptoms accompanying menopause (see hot flashes) and depression. (“Knockoff” term courtesy of CLPsych.) The major media has failed to pick up on Wyeth’s Phase III clinical trials to use Pristiq for fibromyalgia and neuropathic pain (injured tissue or damaged nerve fibers) in diabetics. A search for Pristiq on Wyeth’s Web site yields no results. Desvenlafaxine yields two very meager results.
In related matters, bifeprunox is pending FDA-approval for the use of schizophrenia and is still in Phase III for use of bipolar disorder. They are also in Phase III of testing Lybrex (levonorgestrel) for use for Premenstrual Dysmorphic Disorder in addition to the drug functioning as an oral contraceptive. (I’ll be honest; I had NO clue that diagnosis existed.) In any event, I’ve been misdiagnosed because according to the symptoms, I qualify. I think I also qualify for OOPS – Overdiagnosed and Overmedicated Patient Syndrome.
I’d like expound on Wyeth’s Learn and Confirm phase that’s supposed to replace Phase I and II of clinical trials. It sounds like a speedier way to just get drugs to Phase III of clin. trials, but it’s late and I’m working on something else, so I’ll save that for another day.
Also something to tackle in the future: All these interesting clinical trial results for Effexor XR involving depression and GAD. We’ll see…
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Pristiq's FDA Chances: Depression – Yea; Menopause – Nay
As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.
While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."
"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."
Continue reading “Pristiq's FDA Chances: Depression – Yea; Menopause – Nay”
Pristiq gains ground with FDA
FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.
Some of the "quality control" problems Wyeth is experiencing:
- unclear whether Pq keeps depressive episodes at bay
- efficacy at low doses and in young kids
- severe nausea in 50 percent of patients in the clinical trials
Reuters' article notes this, though:
"But the studies do not need to be completed prior to approval of the new depression pill."
While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."
But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.
Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.
"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."
Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.
"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."
Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.
Pristiq posing as pristine
The Trouble With Spikol has linked to an article in the San Diego Union-Tribune (via Reuters) that covers Wyeth's new Effexor XR knock-off, Pristiq (desvenlafaxine succinate). Why are they launching Pristiq? Their patent on Effexor will expire in July 2010 when making generic versions of the drug will be up for grabs.
"Wyeth said in July, however, that it will not introduce Pristiq until it completes tests of a low 50-milligram dose of the drug, following trials of higher dosages in which about half the patients experienced nausea."
Too bad clinical trials don't test for withdrawal symptoms. Will Pristiq avoid the withdrawal hell issues that Effexor XR has?
“'We will wait for the results of the low-dose trials, which we've said we expect in early 2007, before making a decision' on when to launch Pristiq, company spokeswoman Gwen Fisher told Reuters on Friday.
She said nausea seen in the earlier trials was mild to moderate and generally went away within a week after treatment began.”
How long were these clinical trials and if the nausea was seen in the "earlier trials," what about the most recent trials?
Pending FDA approval, Wyeth would also like to use Pristiq for vasomotor symptoms in menopausal women. Wyeth's unannounced strategy will be to introduce Pristiq long before Effexor's patent expires so they don't lose any of their $1 billion market share to an Effexor generic.
A Wyeth PR that went under my radar:
“Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) now is being studied with a specific focus on women. It initially was developed for two indications that currently are pending approval from the U.S. Food and Drug Administration (FDA) – the treatment of major depressive disorder (MDD) and vasomotor symptoms (VMS) associated with menopause.
In the area of depression, Pristiq is expected to improve the balance of serotonin and norepinephrine as compared with serotonin reuptake inhibitors (SSRI) because of its pharmacologic profile as a dual reuptake inhibitor.”
Isn’t that what SNRIs are supposed to do?
“Clinical studies confirm that Pristiq is effective in both men and women. However, women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology.”
No kidding – 50 percent of the depression market and the implication of all women over 40 years old? Sure, I believe that. Looks like Wall Street doesn't have much hope for the new drug either.
“Pristiq also may be a treatment option for patients who are on multiple medications. The compound has a low risk of drug-drug interactions. This is important when considering that depression often is a co-morbid condition in medically ill patients and that these patients frequently are taking multiple medications. The Company expects FDA action for the MDD indication in January 2007.”
The multiple medications thing. Um, I’m not a fan of that unless it’s absolutely necessary. It isn’t necessary in a lot of cases.
“FDA action for the second application for Pristiq for vasomotor symptoms associated with menopause is anticipated in April 2007. Pristiq is expected to provide significant relief of hot flushes (decrease in number and severity) associated with menopause.
If approved, Pristiq will be the first non-hormonal treatment indicated for relief of VMS.
The Company also plans to pursue indications for Pristiq that would include fibromyalgia syndrome and diabetic neuropathic pain.”
Wyeth certainly is attempting to milk this new drug for all it’s worth. I hope Furious Seasons or CLPsych take up on investigating this one since I simply don’t have the time, resources, or ability.