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”

A final update on my Effexor withdrawal

I failed to update on my Effexor withdrawal because, well, you know why.

After three to four weeks, my Effexor symptoms – well, most of them anyway – have dissipated. The brain shocks were gone by early February. The vertigo as of now has completely resolved. (Although I’ll probably still have occasional instances where it may linger.) The dizziness also has lightened up. I can confidently say that I’m pretty much back-to-normal. All cases will differ, but for me, it took about five weeks total to have a complete recovery.

But don’t do headstands after Effexor – whoo, boy, can that throw you for a loop.

Also – it took about four weeks to get the drowsy effect of fluoxetine (Prozac) out of my system. January was an extremely rough month for meds, let me tell you.

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.

UPDATE: Venlafaxine withdrawal symptoms

I previously wrote about how fluoxetine helped smooth out my withdrawal from venlafaxine. I’m doing much better and am able to function.

What’s the update then?

I’ve got lingering side effects from either the fluoxetine or the venlafaxine – I’m not sure which.

somnolenceThe lingering somnolence/grogginess for about a week or so can definitely be attributed to fluoxetine. I’d never struggled with somnolence on any med except when I first started Effexor in the hospital. Grogginess has never been a problem except for my antihistamine medication hydroxyzine.

The brain shocks still linger. They’re not as bad nor are they frequent. I can walk around, turn, spin – no problem. But if I’m in the middle of walking  down the street and turn my neck slightly to see if a car is coming before I cross – *zap!* – brain shock. That’s all I get for the rest of my 15-minute walk. I’d say that’s pretty good (considering what I’d previously endured).

Dizziness, vertigo, and light-headedness: those are much more frequent. As I sit here and type, my entire field of vision can swirl clockwise and return to normal via counter-clockwise. It happens for about 3 seconds or less, but it’s long enough for me to notice and go, “Whoa.” (Who needs recreational drugs when you’ve got withdrawals from psych meds?) These side effects are not as frequent as they used to be with the direct venlafaxine withdrawal, but they can occur about 30 times or less throughout a 17-hour day (7 a.m.-12 a.m.) for me.

I’ve read that people can use fluoxetine to offset venlafaxine withdrawal symptoms with relatively uneventful side effects. Somnolence was not a fun side effect. Just a warning.

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.

Seroquel abuse and medication weight gain

SeroquelFurious Seasons has blogged about Seroquel (quetiapine) in the past and he recently posted on Seroquel abuse in an Ohio prison. Apparently, inmates have been snorting the atypical antipsychotic, also known in slang terms as “quell” or “Susie-Q.” Excerpt from Furious Seasons:

“Second, we all know that Seroquel is regularly handed out to bipolars and depressives and people with anxiety in order to address insomnia, as opposed to the kind of underlying psychosis/mania issues you’d expect it to be used for. PCPs hand it out this way and so do psychiatrists. What I have noticed among friends who’ve been given Seroquel for sleep issues is that they end up, over a few months time, needing more and more of the drug in order to get an effect. Or, put another way, people keep complaining of problems with sleep despite taking, say, 300 mgs. of Seroquel and their doctor will keep upping the dose to get the desired effect. As a result, I have seen people with very mild bipolar disorder wind up taking 800 mgs. of Seroquel a day–that’s roughly the same that a schizophrenic in a state hospital would get–and still they get no results, aside from putting on tons of weight. I have heard this from other readers of this blog as well.”

My aunt, who works in the psych wing of a hospital, warned me that she’s seen patients on Seroquel gain weight. A man I met at my Bipolar and Depression Alliance Group last night gained 60 lbs since taking Seroquel. I can’t image that everyone who takes Seroquel overeats to a point of obesity and leads a sedentary lifestyle. I have a random theory that Seroquel signficantly slows a person’s metabolism down to the point where it is difficult for a person to lose weight.

Continue reading “Seroquel abuse and medication weight gain”

Venlafaxine withdrawal symptoms

Work has got me busy, folks, so posts may drop significantly in the next coming days/months. Possibly through April or May. (I’ll probably have one of those work days when I end up doing more blogging than working. It happens every now and then.) But don’t be surprised if Saturday quotes, Wednesday puppies, and Sunday stats are what pops up each week. I’ve got many of those backlogged through April. I’ll try to backlog some other posts on bipolar disorder and depression for the coming weeks and quickly blog on anything that’s timely.

electric shockIn the meantime, I had to take a sick day today. It’s my third day off of the Effexor and I’m having some weird side effects (see Case 1: Standard Dose under the link). Whenever I turn or move too quickly (consider your “natural” body turn), I “kind of” see stars and the whole world slightly spins beyond my field of vision for about 3 seconds before coming back into focus. After doing some light research on the side effects of venlafaxine (Effexor’s generic name), I’ve found out that side effects can incude vertigo, dizziness, light-headedness (associated with dizziness), and something called “brain shivers,” which are a form of electric shock sensations. You know that feeling when you get an electric shock from somebody? Yeah, imagine feeling that throughout your whole body. Precisely; not a good feeling. Nancy Schimelpfening, blogger for depression.about.com, found a newsgroup posting on the brain shiver effect, mainly associated with venlafaxine:

It happens to me if I turn my head quickly, or if I stop suddenly, or in general with sudden motion. They’re worse if I’m nervous.

i’ve seen them described as feeling as though your brain keeps going when you turn your head. that doesn’t seem quite adequate to me. it’s more like this:

you turn your head (or your whole body — this happens to me if i whirl around too quickly as i’m taking the stairs. what. doesn’t everyone whirl on the stairs…?), but your brain *stays put* for a micro second, then tries to catch up but only in a stuttering, stopstart motion, accompanied by a staccato ‘zzt zzt zzt’ with each stop. the ‘zzt’ you can feel in your head, an electric sort of vertigo, and it often reverberates in your hands and fingers. some folks feel it in their toes; i haven’t yet.

sometimes your brain overshoots and comes strobing back, then overshoots again.. this all unfolds in just a second or two.

these days i endeavor to go around corners all smooth slow and steadylike. helps to reduce the number of brain shivers per day

Yeah, that’s me. It’s hard to explain to someone who’s never felt it. I got this feeling after not taking Paxil for three days too. The effects eventually wore off, but it was such a weird feeling.

Continue reading “Venlafaxine withdrawal symptoms”

Loose Screws Mental Health News

Surprise, surprise — the likelihood of suicide attempts increases with antidepressants.

     “Suicidal patients taking antidepressants have a ‘markedly increased’ risk of additional suicide attempts but a "markedly decreased" risk of dying from suicide, a large Finnish study has found.
     “The research into nearly 15,400 patients hospitalized for suicide attempts between 1997 and 2003 showed that ‘current antidepressant use was associated with a 39 percent increase in risk of attempted suicide, but a 32 percent decrease in risk of completed suicide and a 49 percent reduced risk of death from any cause,’ the authors wrote in a report published in the Dec. 4 issue of Archives of General Psychiatry.
      “The Finnish study analyzed 15,390 suicidal patients of all ages for an average of 3.4 years. The authors said they did this ‘because previous suicide attempts are the most important risk factor for predicting suicide.’”

I think 15,390 patients is a sizeable, significant study that could probably yield semi-accurate statistics.

      “Among the 7,466 males and 7,924 females examined, there were 602 suicides, 7,136 suicide attempts requiring hospitalization and 1,583 deaths recorded during follow-up. The risk of completed suicide was 9 percent lower among those taking any antidepressants than among those not taking antidepressants.
     “But the picture was not so bright for all those who took SSRIs. It was for those taking fluoxetine (Prozac), who had a 48 percent lower risk of suicide than those not taking medication. But the study found that those taking another SSRI, venlafaxine hydrochloride (Effexor XR), had a 61 percent increased risk.”

So Prozac is better than Effexor XR in terms of suicidal risk. Nice, considering that I've had a 10-year history of suicidal attempts and this study seems to show that venlafaxine increases the risk of suicide attempts. Perhaps Effexor should be prescribed to those who aren't/have never been suicidal?

Continue reading “Loose Screws Mental Health News”

Well-intentioned but not completely right

medicating the brainI read this commentary from the Philly Inquirer on mental illness and the author insists that mental illnesses are all “chemical imbalances.” While I do think many mental illnesses are the result of chemical imbalances, some mental illnesses are not physical. Some mental illnesses come from a spiritual and/or psychological battle. There are many people who recover from mental illness without medication. If a chemical imbalance was the case for these people, they would never get better. Pharma companies have sold the American public and countless mental health organizations on the idea that millions of people suffer from a “chemical imbalance.” I don’t buy that – well, come to think of it, actually, I do – my dollars contribute to Wyeth and GlaxoSmithKline‘s profits.

After suffering from bipolar disorder (or depression, depending on which psychiatrist I listen to) for 10 years, my husband and I are leaning toward the “chemical imbalance” theory that many doctors and pharmaceutical companies push. But a person who is depressed over a temporary situation does NOT have a chemical imbalance and simply may need psychological counseling.

America is overmedicated, drugged-up, and the victims of the smartest ad campaigns from pharma companies. What concerns me even more is that the FDA and mental health organizations like NIMH buy into many of the pharmaceutical companies’ lies and tactics. What further concerns me are the doctors involved in clinical trials who fail to disclose their affiliations with many of these pharmaceutical companies.

So yes, chemical imbalances do exist for many people. Millions? It’s possible. But unlikely. And I could go off on another rant about how PCPs shouldn’t be prescribing psych meds, but I’ll leave that argument for another day.

PCPs Don't Know Jack From Zyprexa

Eli Lilly’s actions continue to be appalling.

LillyApart from trying to hide the fact that Zyprexa induces weight gain, diabetes, and hyperglycemia, they also had sales reps encourage primary care physicians to prescribe Zyprexa for patients who did not have schizophrenia or bipolar disorder (basically off-label usage).

It seems that Lilly told marketing reps to suggest Zyprexa for dementia in the elderly. Lilly denies this, of course, since olanzapine (Zyprexa’s generic name) is not approved for that kind of use since it increases the risk of death in seniors with psychosis associated with dementia. Lilly also attempted to market olanzapine to patients with mild bipolar disorder who suffer mainly from depression. (In actuality, Zyprexa is approved to treat those who suffer from mania.)

This issue with Eli Lilly delves into precisely why I am against PCPs prescribing psychiatric medicines. Primary care physicians don’t know enough about the various psychiatric conditions to prescribe the appropriate kind of medication. This type of prescription should be left to specialists like psychiatrists. PCPs should focus on the things they deal with on a daily basis that no one else can take care of: the common cold, the flu, annual physical, etc. It should be the job of the PCP to refer a patient to a psychiatrist should they present symptoms of mental illness (depression, schizophrenia, etc.). I have been burned by having a PCP prescribe antidepressants for me and as a result, attributed my horrible experience with drugs to that.

Continue reading “PCPs Don't Know Jack From Zyprexa”