Posts Tagged ‘ paxil ’

Giddy with Glee: FDA Got One Right with SSRI Drug

October 18th, 2010. By AbiK

Or so it appears.

A little bomb just dropped in the form of a report out in the British Medical Journal (BMJ) regarding the antidepressant drug reboxetine. Reboxetine—brand name Edronax—is one of the drugs classified as a Selective Serotonin Reuptake Inhibitor, or SSRI, and it’s manufactured by Pfizer. According to the report, data from industry-sponsored (biased?) trials that have been published in peer-reviewed journals are misleading when it comes to reboxetine’s safety and efficacy.

How did this happen? Well, according to an article over at medscape.com, the BMJ reports that “74% of the data on patients who took part in the trials of reboxetine were not published because the findings were negative and that the data that were published about reboxetine overestimated its benefits and underestimated its harm.”

Huh?

I feel like I’m sitting in a management meeting—not at LawyersAndSettlements.com mind you—where we’ve just received the results of an employee feedback survey—that happen to suck—and we’re all trying to figure out how to save face and mitigate any fallout. What to do? LIE! Or, simply be selective in what information gets revealed…

So re: reboxetine, little bothersome details like the trial revealed that there was no significant difference in remission between reboxetine and a placebo, and that reboxetine was found to be inferior to other SSRIs such as fluoxetine (Prozac), paroxetine (Paxil) and citalopram (Celexa), just never hit the light of day. Until now.

But here is what makes me giddy with glee: reboxetine had been approved for marketing in the UK, Germany and “other European countries” according to the medscape.com article….”but did not win approval in the United States.”

Looks like the FDA got one right! Can it be so…?

Tags: Celexa, Edronax, FDA, paxil, paxil-heart-defects-newborn, Prozac, Reboxetine, SSRI
Posted in Drugs/Medical | 2 Comments »

Mom Alert: Would you want a 68% Higher Risk of Miscarriage?

June 2nd, 2010. By LucyC

A new study out yesterday—June 1, 2010—has revealed a higher rate of miscarriages in women who were taking antidepressants during pregnancy. How much higher? Sixty-eight percent—yes —that’s 68%—higher. Frankly, that is nothing short of shocking.

Published in the Canadian Medical Association Journal, the study was done in Canada through the University of Montreal. FYI—This was no small study either—the investigators used data from 5,124 women who are part of a large, population-based study of pregnant women who had clinically verified miscarriages, and a large sample of women from the same registry who did not have a miscarriage. Among the women who miscarried, 284 or 5.5 percent, had taken antidepressants during their pregnancy.

In fact the findings are so robust that the physicians who did the study are suggesting that this is a class effect—in other words the effect could be attributed to all selective serotonin reuptake inhibitors—or SSRIs. Here’s what’s being reported in the press:

“These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied,” the study’s senior author, Dr. Anick Berard, said in a statement. (UPI.com)

The antidepressants that showed a particular association with miscarriage in the study were paroxetine (trade names: Seroxat and Paxil) and venlafaxine (trade names: Effexor, Efexor, Alventa, Argofan, Trevilor). The investigators also found that the risk of miscarriage doubled with a combination of different antidepressants.

Just for the record, the antidepressants “investigated” in the University of Montreal study are serotonin reuptake inhibitors (citalopram, fluoxetine, fluvoxa-mine, paroxetine and sertraline); tricyclic antidepressants (ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine), Read the rest of this entry »

Tags: Celexa, Cymbalta, Effexor, Lexapro, paxil, paxil-heart-defects-newborn, Prozac, SNRI, SSRI, Zoloft
Posted in Drugs/Medical | No Comments »

Antidepressant Guide: the Brands, the Generics & Who Makes Them

May 6th, 2010. By Kristine B

These days, there are many drugs to keep track of. It’s not just the brand name drug anymore; patients could be taking a generic equivalent. So, this week, Pleading Ignorance looks at the SSRIs and SNRIs to give you the brand name, manufacturer, generic version and the generic’s manufacturer. Consider it your one-stop cheat sheet on some of the more commonly prescribed antidepressants.

Brand name	Ingredient	Made By	Generic	Made By
Celexa (SSRI)	citalopram hydrobromide	Forest Laboratories	citalopram	Eon Labs, Inc., Aurobindo Pharma Limited, Purepac Pharmaceutical Co., Dr. Reddy’s Laboratories Limited, Corepharma LLC
Lexapro (SSRI)	escitalopram oxalate	Forest Laboratories	escitalopram	Alphrapharm
Paxil/Seroxat    (SSRI)	paroxetine hydrochloride	GlaxoSmithKline	paroxetine	Apotex, Alphapharm, Teva, Aurobindo Pharma, Zydus Pharms USA, Caraco
Prozac (SSRI)	fluoxetine hydrochloride	Eli Lilly and Company	fluoxetine	ESI Lederle (tentative approval)
Symbyax (SSRI)	olanzapine and fluoxetine hydrochloride	Eli Lilly and Company	olanzapine/ fluoxetine	Teva Pharms (tentative approval, July 17, 2007)
Zoloft (SSRI)	sertraline hydrochloride	Pfizer Pharmaceuticals	sertraline	Dr Reddy’s Labs Ltd, Teva, Genpharm, Aurobindo Pharma, Sandoz and many others
Zyprexa (atypical antipsychotic)	olanzapine	Eli Lilly and Company	olanzapine	All tentative approval: Dr. Reddy’s Labs Inc, Teva Pharms, Mylan PHarma, Sandoz, Barr Pharms, Roxane
Cymbalta (SNRI)	duloxetine hydrochloride	Eli Lilly and Company	duloxetine	No generic so far as I can tell
Effexor (SNRI)	venlafaxine	Wyeth	venlafaxine hydrochloride	Aurobindo, Mylan, Teva, Dr Reddy’s Labs Ltd, Caraco and others

The information in the chart above was found at either drugs@fda, or on the individual drug manufacturer’s website. As far as I can tell, this information is correct as of the date it was written—and it is not intended to replace the information you might receive from your doctor or medical practitioner (hey, have to say it, we’re a legal site). Talk to your doctor or pharmicist for medical advice.

Tags: Antidepressants, Celexa, Cymbalta, Effexor, Lexapro, paxil, paxil-heart-defects-newborn, Pleading Ignorance, Prozac, SSRI, Symbyax, Zoloft, Zyprexa
Posted in Drugs/Medical, Emerging Issues | 1 Comment »

Antidepressants: Know What They’re Winding You Up With

April 16th, 2010. By Kristine B

C’mon. You know you’ve seen that Pristiq ad once or twice—the one with that little wind-up doll (yes, the one with the circa-1970’s get-up that would drive any of us into a state of mild depression)—and you’ve thought to yourself, “Gee, I’ve had days when I kind of felt that way”. Admit it folks, you’ve been there—maybe not in mauve polyester, but you’ve been there.

Now, you may or may not have taken that thought to the next level: the “I need help” level. Most of us don’t. But if you have, you’ve most likely “talked to your doctor” as only “he can determine whether [fill in anti-depressant drug name here] is right for you”.

And if you’ve left your doctor’s office with a little slip of paper to be dropped off at the pharmacy, you may have been prescribed an SSRI, SNRI, NDRI or MAOI. Perhaps you’re feeling high as a kite on the hopes that you’ll be giddier than a glee club as soon as you get that scrip filled. But, take pause. For while you fantasize about your future mental state, do you really know what you’ve just been given?

What follows is a mini primer to the world of anti-depressants—and, as this is a legal news site, the links provided will lead you to information on safety concerns and some of the resulting litigation that’s gone on.

There are actually many different types of antidepressants. Not just the brand names, but the actual types of drugs themselves that work on different chemicals in the brain. Generally, antidepressants aim to reverse depressive symptoms and stabilize mood by increasing the amounts of certain chemicals that are found in the brain. The type of antidepressant depends on the chemicals being affected. 

Depression 

Although there is no one answer to the question, “What causes depression?” scientists believe that chemicals in the brain play a role in some forms of depression. The brain has several hundred types of chemical messengers—also called neurotransmitters—that send messages between brain cells. Of these, three neurotransmitters specifically are targeted by the various antidepressants, to different degrees. 

Serotonin is thought to play a role in controlling anxiety, mood, sleep, sexuality and appetite. 

Norepinephrine is thought to play a role in sleep and alertness and is also thought to play Read the rest of this entry »

Tags: Antidepressant, Celexa, Cymbalta, Effexor, Lexapro, MAOI, NDRI, paxil, paxil-heart-defects-newborn, Pristiq, Prozac, SNRI, SSRI, Wellbutrin, Zoloft
Posted in Drugs/Medical, Emerging Issues | 3 Comments »

Paxil Birth Defects Trial Underway in Nation’s Birthplace

September 14th, 2009. By AbiK

It’s somehow eerily fitting that the bellwhether trial case for GlaxoSmithKline’s (GSK) Paxil is taking place in Philadelphia—the nation’s birthplace. You can’t really think of such a trial going on in Philly without recalling a few excerpts from the Declaration of Independence—and not just the more famous lines about unalienable rights but also some lesser quoted phrases like “Such has been the patient sufferance of these Colonies”; substitute the word “mothers” for “colonies” and you’ve just advanced 233 years to be talking about Paxil.

At the heart of the trial that’s now underway is GSK’s allegedly knowing—and failing to warn patients—that its anti-depressant drug, Paxil, could cause birth defects.

All eyes are on this first case which centers on Lyam Kilker, now 3, who has suffered life-threatening heart defects since birth. According to bloomberg.com (9/11/09), Michelle David, Lyam’s mother, was quoted as saying that:

…she was prescribed Paxil during her first trimester to treat mild anxiety. Lyam was born with defects including two holes in his heart as a result of taking the drug, she said in court papers. The infant underwent multiple surgeries within six months of his birth, she said.

She said wouldn’t have taken Paxil if she knew of the risk and contends that Glaxo failed to warn her or her doctors.

“All of Ms. David’s physicians who prescribed Paxil just prior to and during her pregnancy with Lyam have testified that had they been warned that Paxil could increase the risk of cardiovascular heart defects, they would not have prescribed it to her,” according to court papers.

Needless to say, GSK’s position is that there’s no mea culpa; however, reports estimate at least 600 additional cases waiting in the pipeline for the outcome of this trial to say just whose culpa it is. For the sake of legacy of our forefathers, let’s hope prudence prevails.

Tags: Glaxo, GSK, paxil, paxil-heart-defects-newborn
Posted in Drugs/Medical | 2 Comments »