Pristiq (desvenlafaxine) information

Here’s a list of compiled links providing information on Pristiq. These links include info from my blog and others.

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FDA: No link between Singulair and suicidal behavior

On Tuesday, the FDA announced that an investigation into Merck’s clinical trial data did not discover a link between Singulair (montelukast) and suicidal behavior. The investigation, which began 9 months ago, was prompted by a number of reported suicides, especially that of 15-year-old Cody Miller who took the drug and appeared to have no history of mood or behavioral problems. (It is worth noting here that Singulair “is the top-selling drug for people under 17 years old” and Merck’s biggest seller with annual sales of close to $4.5 billion.)

In attempt to assess Merck’s data better, the FDA also investigated AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’s Zyflo (zileuton). Although the FDA did imply that “the data were inadequate to draw a firm conclusion” and said that the clinical trials were not set up to observe any psychiatric behavior. Here are the data the FDA discovered during their review of these trials:

SingulairSingulair: 41 placebo-controlled trials that included 9,929 patients

  • Reports of suicidal thoughts: 1 (treated with Singulair)
  • Attempted suicides: None reported
  • Completed suicides: None reported

AccolateAccolate: 45 placebo-controlled trials that included 7,540 patients

  • Reports of suicidal thoughts: 1 (placebo group)
  • Attempted suicides: 1 (placebo group)
  • Completed suicides: None reported

ZyfloZyflo: 11 placebo-controlled trials (number of patients unknown)

  • Reports of suicidal thoughts: None reported
  • Attempted suicides: None reported
  • Completed suicides: None reported

Forgive me for being cynical but the data sounds fishy. I can’t pinpoint why but it does. The suicide numbers and patient involvement data seem to deviate some from the numbers listed in Merck’s PR issued last March. (I’m seeing 11,000+ patients vs. 9,929 patients.) Regardless of the clinical trial data, it appears that the FDA as of yet have not reviewed post-marketing data.

Scott Korn, a senior safety surveillance executive for Merck said in an article for Reuters:

“‘At the time we did not believe, and we still don’t think a link has been established’ between Singulair and the suicides.”

In the same article, Sanford Berstein analyst Tim Anderson had this to say about the possibility of the FDA finding a link:

“If the… safety review leads to a stern warning about behavioral changes in the Singulair label, this could frighten users of the drug or their parents and give Merck’s competitors ammunition to attack the brand.”

The Washington Post has Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas, on record saying that he had not “seen any increase in psychiatric problems with the drug but that some patients had complained of nightmares after starting on Singulair.” (Note: It appears that the closest conflict of interest Weldon would have here is that he served as a consultant and is honoraria for AstraZeneca.)

Dr. Rauno Joks, head of the SUNY Downstate division of allergy and immunology, made an interesting point in the Washington Post article:

“The physician really needs to review whether there are symptoms that have developed since patients started taking the medication, if there’s an underlying depression that was there before medication started.

Also, seasonal allergies in and of themselves can cause fatigue and lethargy, which makes it harder to assess, because those are some of the symptoms you have with depression.”

The FDA says they’ve completed analyses of submitted clinical trial data but their “safety review will continue” for several more months before they come to a concrete conclusion. For customer testimonials, check out medications.com that has over 2,300 people reporting side effects and askapatient.com that has an average 2.3 rating from 524 reviewers. The most commonly reported mood-related side effect on both of the sites is irritability.

Christian counseling: Nouthetic vs. Biblical

Last night, I spent some time on the phone with my husband’s friend’s sister (aka my former pastor’s sister). We’ll call her Natalie.

Natalie was very sweet and kind, really encouraging and strengthening me by sharing her testimony of faith in God. She suffers from anxiety and panic attacks, which has led her to take Paxil (on and off) for the past 7 years. She says the drug has helped her tremendously and who am I to knock the drug (knowing what I know about Paxil/Seroxat) when she has seen the wonders that it has worked in her life?

I briefly explained my story of depression, history of suicide, and diagnosis of bipolar disorder. Although she couldn’t fully relate, she was very sympathetic and understanding. In fact, our conversation was so fruitful, I ended up taking notes!

Jay AdamsWe briefly touched on the issue of Nouthetic counseling (NC). She has undergone the course and simply needs to be certified. The counselor I currently see is associated with the Christian Counseling Education Foundation (CCEF), which has roots in NC and was founded by the man—Jay Adams—who developed the method. However, CCEF is now known for what is called biblical counseling. The organization has since moved away from pure Nouthetic methods and become more a bit more varied, taking bits and pieces of psychology (and perhaps psychiatry) that line up with the Bible. Adams, disagreeing with the organization’s approach, founded the Institute for Nouthetic Studies and uses the Bible as the sole counseling textbook. According to the wiki entry on Nouthetic counseling, Adams developed the word Nouthetic based on the “New Testament Greek word noutheteō (νουθετέω), which can be variously translated as ‘admonish,’ ‘warn,’ ‘correct,’ ‘exhort,’ or ‘instruct.'”

NC was developed back in the ’70s as a response to the popularity of psychology/psychiatry. Many Christians reject some of the teachings of such popular psychologists as Freud, Jung, Adler, Maslow, etc. Adams’ highly successful book, Competent to Counsel, criticizes the psychology industry and counters its teaching with a Nouthetic approach.

But NC has its Christian critics.

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Lamictal in consideration of pregnancy

My husband and I are talking about expanding our family. While that sounds all well and good, I just have one issue:

Lamictal.

For most women, they think, “Well, I want a kid” and the most they have to do is probably get off birth control. Just finish off their contraceptives, maybe feel a little nauseous, and move forward with their plans.

(sigh) Not me. If I want to do this right, it might be a good 6 months or so before I can consider trying.

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Generic Lamictal (lamotrigine)

I'm on "Day I-don't-know" of lamotrigine (generic Lamictal). It's been at least 2 weeks. I haven't had any significant side effects except for extreme fatigue. I am often tired. Some days, I can give myself a boost of energy by playing the Wii Fit (which I snagged Saturday afternoon) and other days, exercising just wears me to out to the point where I head to the shower and then to bed. I can have 3 cups of coffee, never become fully awake, and still go to sleep at a decent time.

I'm still not sleeping well. Haven't slept well since before I went into the hospital in October 2006. I can't remember the last time I had truly restful sleep.

My symptoms remain at bay. I haven't had many suicidal thoughts or impulses. In fact, some days, I can go without thinking about suicide at all. I can't say it's all the medicine — my counseling and faith play a much bigger role — but I'm sure the medicine helps.

I've recently noticed that I'm not suffering from as much social anxiety. Again, I don't know if this is due so much to the medication as it is to the resurgence of my spiritual life. I ventured out on Sunday to a meetup writers workshop group that I'd never been to before. It was extremely weird. Not the situation, but the fact that I walked into a room full of strangers, made myself comfortable on the couch at the coffeehouse and offered input quite freely without worrying about what the others thought of me. I even had the audacity to network with a woman who works at a trade magazine in the area. How strange. I don't have balls. This is not me.

What the heck has happened to me?

Loose Screws Mental Health News

The mastermind behind Stavzor is Noven Pharmaceuticals (in conjunction with Banner Pharmacaps Inc.). The new “small, easy-to-swallow soft gel capsule” is available in three strengths: 125, 250, and 500 mgs. The pills are are “up to 40% smaller than han Depakote® and Depakote ER® tablets at the 500 mg dosage strength.” From Noven’s PR:

Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches.

The drug will hit the market in mid to late August.

The hotline receives an average 250 calls each day from veterans that have fought in Iraq, Vietnam, and Afghanistan.

The issue of soldiers with mental illness has recently come to light with studies showing that 1 in 5 soldiers returning from Iraq and Afghanistan have shown symptoms of post-traumatic stress disorder. The issue of the high suicides rate has been a high priority of the VA since mental health director Ira Katz tried to hide the significant number of suicides committed by veterans.

The National Suicide Prevention Lifeline is available 24 hours a day by calling 800-273-TALK (8255); veterans should press “1” after being connected.

“We have seen a 60 per cent increase in demand for our child anxiety classes in the past six months,” said [Dr. Kimberley O’Brien, of the Quirky Kids Clinic at Woollahra in Sydney].

It sounds more like the article is speaking of children who are exposed to constant physical and emotional abuse. If that’s the case, shouldn’t there rather be an increase in parenting properly classes?

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:

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Lexapro maintains status as first-line antidepressant therapy

Lexapro vs. Pristiq According to a Decision Resources (DR) press release, Lexapro (escitalopram), a SSRI, “retains leadership among first-line therapies in the treatment of major depression” despite the fact that physicians have increasingly moved toward the use of SNRIs, eg, Effexor (venlafaxine). However, the reason why SSRIs still retain their first-line status is due to

  • cost
  • efficacy
  • familiarity

SSRIs have been out on the market for much longer than SNRIs so it’s what physicians are more comfortable with. As far as I know, there currently aren’t any generic SNRIs in the U.S.

As a result, SNRIs are likely pricier.

DR’s survey of psychiatrists found that the majority believe SNRIs work better in treating clinical depression than SSRIs and about 44 percent believe they have fewer sexual side effects. PCPs were also included in this survey and it seems that the majority of them believed the opposite despite DR’s spin that a lot of PCPs are on board with psychiatrists. From personal experience, four SSRIs were prescribed to me before I was shifted to a SNRI.

In the up-and-coming SNRI department, DR forecasts a bright future for Pristiq (desvenlafaxine).

Physicians are expected to move patients from Effexor to Pristiq-a newly approved SNRI- over the next two years. … Pristiq will begin to replace Wyeth’s Effexor XR and Lilly’s Cymbalta, especially in
psychiatrists’ practices.

This is an interesting analysis from DR considering that psychiatrists, health insurers, and even some investors seem less than impressed with the slight advantages the “me-too” drug has over Effexor.

(logos from Forest Pharmaceuticals, Inc. and Wyeth)

Poor Wyeth — New drug delayed in FDA approval

From Forbes.com:

Wyeth Pharmaceuticals just can't seem to catch a break. The company is not only increasingly worried that it will lose a large chunk of its revenues to generic competition, it also faces the ongoing threat that its pipeline is starting to go dry. A further delay in the approval of its postmenopausal osteoporosis drug has become one more nail in the pharma company's coffin.

The drug, bazedoxifene, has had a hard time getting approval from the FDA since April 2007.  The FDA is concerned about bazedoxifene's effects on causing myocardial infarctions or blood clots.

This is some pretty disheartening (to say the least) news considering that Effexor will soon be going generic and Pristiq has received some less-than-stellar reviews.

Wyeth Pushing Pristiq Hard

PristiqThe Wall Street Journal reports that Wyeth, desperate to make money off of its Effexor XR-knockoff, Pristiq, says it will slash the antidepressant at a 20% discount compared to Effexor’s price. The price slash, CNN money reports, is a result of less-than-impressive clinical trial data on Pristiq’s “safety and effectiveness.”

Wyeth SVP Joe Mahady told analysts that Pristiq will sell for a flat $3.41 per tablet for both mid- and high-dose, Dow Jones Newswires’ Peter Loftus reports.

Wyeth, apparently, has done this in the past. Back when it was known as American Home Products, the company slashed its price on Protonix, its heartburn drug, to compete with AstraZeneca’s Prilosec. The drug generated $1.9 billion in profits for Wyeth last year. CNN Money reports that Teva Pharmaceuticals and Sun Pharmaceuticals began selling the generic version of the drug and handily cut into Wyeth’s profits: the company reported a 4.6% decline in profit and a 66% drop in sales for the drug for the first-quarter. What will happen with Pristiq remains to be seen. I’m not sure that doctors in 2010 will want to dole out prescriptions for Pristiq when they can save patients—and insurance companies—money by prescribing what will then be known as venlafaxine. WSJ also notes:

A month’s supply of sertraline (Pfizer’s old hit Zoloft) or fluoxetine (Lilly’s Prozac) goes for 50 cents a day at drugstore.com.

$3.41 or $0.50 per tablet. It wouldn’t surprise me if some insurance companies choose to exclude Pristiq from its list of covered drugs. Regardless, Wyeth expects sales of the drug to exceed $1 billion in its first year.

The drug will hit the shelves in May.

Brief update on Singulair-suicide link

Merck issued a press release today responding to the FDA’s investigation. Along with the standard "we didn’t know about this problem until after it the market" disclaimer, the PR mentioned:

In a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with SINGULAIR, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received SINGULAIR.

Additionally, in a cumulative analysis recently provided to the FDA of Merck’s randomized, double-blind, clinical trials that compared SINGULAIR with other active agents to treat asthma (which included over 3,900 adults and children who were treated with SINGULAIR and over 3,400 who were treated with other asthma therapies), there was 1 patient who attempted suicide who received SINGULAIR, and there were 3 patients who attempted suicide who received other asthma therapies (including inhaled corticosteroids and long-acting beta-agonists).  These studies were not designed to compare the rate of suicide in patients taking SINGULAIR with the rate of suicide in patients taking these other asthma agents.

Did Merck report that one suicidal attempt when compared to "other active agents to treat asthma"? It doesn’t say anything in their patient safety or prescribing information when I checked. Perhaps someone can find out whether they reported this in their clinical trials?

In the meantime, the Singulair section of medications.com is ablaze with parents who are now expressing concern over their children’s well-being on the drug. Apparently, issues have cropped up with the drug even before the FDA announced their investigation.

Today's lesson: Paxil and Lexapro are not great antidepressants

Dawdy at Furious Seasons wrote a post on an editorial in the LA Times by Summer Beretsky’s experience with Paxil. After reading her editorial, I’m reminded that my own experience with one antidepressant wasn’t all that unique. Her drug was Paxil for panic attacks; mine was Lexapro for depression following a 3-month (on-and-off) stint with Paxil. I’m struck by the similarity of our experiences; not only did the same thing happened to me but I was also a communications major in college as well.

Paxil had one pretty undesirable effect on me: I started to lose interest in just about everything. I stopped initiating social activities (who needs that sort of thing?) and was no longer motivated to perform well academically.

My emotions had flat-lined: I hadn’t cried in months, nor had I proverbially jumped for joy. I felt — nothing.

I can still remember sleeping in bed at home on a weekday when I should have been at class. It was 2 in the afternoon, around the time my copy editing class was to begin. My boyfriend at the time (now my husband) lived in Kentucky while I attended college in New York. He planned to visit me that weekend but was getting fed up with my depression and listlessness. He called from work to tell me to get up and go to class. I mumbled on the phone, half-confused, and said no. He demanded, “Why not?” I said quite plainly, “Because I don’t care.” He said, “If you don’t get up and go to class, I won’t visit you this weekend.”

I replied, “I don’t care.”

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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:

More on Zyprexa

More on Zyprexa, folks. It just isn't going to go away.

NYT reporter Alex Berenson, continuing his stellar coverage of Zyprexa's risks and exposing Eli Lilly's deceitfulness, has uncovered a recent case of a man who died using Zyprexa. John Eric Kauffman has a complicated medical, which might have led to his death. However, he was a mentally ill patient on Zyprexa and as a result of his death, Eli Lilly must report his death to "federal regulators," which it is required to do under law. However, despite his heavy smoking, he gained 80 lbs. on Zyprexa – which possibly led him to develop heart disease and become sedentary after being active most of his life. His mother says that Zyprexa did help him stave off the psychosis of his bipolar disorder, but his mother wonders if the risk was worth the early death of her son. Kauffman at 41 years old weighed 259 lbs. at the time of his death. He was 5' 10".

Which leads to the question of whether mentally ill patients should choose between taking Zyprexa – which CAN help mentally ill people – and dealing with its significant side effects or risk not taking Zyprexa when other medications won't work. In light of all this, should a doctor even continue to prescribe Zyprexa after seeing its awful side effects but left with no other choice (given that a patient is treatment-resistant to most medications)?

Eli Lilly's response to this continues to be appalling:

"Zyprexa is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives."

It may be true that it helps people "regain control of their lives," but as for being a lifesaving drug – that's unlikely. Zyprexa has been shown to induce diabetes, obesity, hyperglycemia, and now, heart disease and death. I commend Australian regulators for looking into the details of Lilly downplaying the risk of Zyprexa and hope that they will make the information public – a different course than what the U.S. federal government seems to be taking. Lilly's 2006 settlement with patients who developed diabetes and other health problems is pure evidence that despite their constant denials, Lilly's hiding something in an effort to make profits.

My prediction: The FDA will eventually slap a black-box warning on Zyprexa, warning patients that it makes them more prone to diabetes and its other ill health effects.