March 23, 2009

FDA Approves Prozac/Zyprexa Combo Drug For Depression

In a sign of just how bizarre things have gotten in DC, the FDA today approved Symbyax for treatment resistant depression, meaning depression that hasn't responded to two anti-depressants. Since anti-depressants don't work too well, that ought to be an easy market for Eli Lilly to market to. Symbyax is Lilly's longstanding Zyprexa/Prozac combo drug. So the FDA just approved a drug that's known to cause diabetes, epic weight gain and suicidality to treat depression. This makes so much sense!

Symbyax has never sold well, so it'll be interesting to see how this plays out.

Separately, the agency also approved Lilly's request to approve Zyprexa and Prozac in separate pills to treat bipolar depression and treatment resistant depression. Seriously.

At this point, I'm certain that you could get literally anything approved for depression.

Let the TV ads begin.

Posted by Philip Dawdy at March 23, 2009 01:43 PM
StumbleUpon Toolbar del.icio.us Digg it reddit
Comments

Unbelievable. Glad I absconded when I did.

Posted by: Lisa at March 23, 2009 04:56 PM

Wasn't the FDA going to have this huge change under the new progressive administration?

Amazing that it still appears as if the FDA is completely on the take, bought, and paid for by the huge pharmaceutical conglomerates’

So much for government looking out for the people they represent. It's also too bad for all those that wasted their time sending in those letters and testimony into the FDA sub-committee on Seroquel XR getting a free ticket to treat just about anything including stubbed toes and tooth aches; since the public hearing is nothing but a check off box in the rubber stamp process.

What wonderful times we live in for all humanity.

Obama, is it true pay back is a ______?

Posted by: Yikes at March 23, 2009 05:17 PM

This is a case study in how marketing prevails over best medical practice. This approval of the combination antidepressant-antipsychotic product Symbyax is bad for patients and may well be bad for Lilly. I told Lilly several years ago that I thought they were foolish and reckless to pursue approval of Symbyax for depression. Symbyax is Zyprexa plus Prozac.

For patients, taking the combination locks them in to a fixed ratio of the two medications, thus removing therapeutic flexibility. The side effect profile of the “atypical antipsychotic” drug Zyprexa is disturbing, and exposes patients to unnecessary risk. The worst side effect, besides the metabolic problems and diabetes, is tardive dyskinesia (TD) with long term use. Depressed patients seem to be especially susceptible to this syndrome of involuntary muscle movements in the mouth, tongue, face, and elsewhere. It can be very disfiguring. And permanent. We can put numbers on this risk of TD. In adult patients with schizophrenia the risk of TD with Zyprexa treatment is about 2.5% at 1 year. In children and adolescents treated with Zyprexa or similar “atypical antipsychotic” drugs for 6 months the risk is an alarming 6%.

So, when Symbyax is promoted early and often for depression in primary care, look for a new cohort of patients with TD and a fresh round of lawsuits against Lilly. This is a case where psychiatrist key opinion leaders have been found wanting and where patients will be damaged unnecessarily.

Here are some links.

http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html#links

http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html#links

Posted by: Bernard Carroll at March 23, 2009 07:11 PM

Lisa,
Me too! Me too!
So glad I made my escape from the psych "profession", their assurances of my everlasting damnation if I left them, their dangerous and ineffective drugs, their little machines to fry my brains...
Sherry (much improved on ten dollars worth of levothyroxin and Vitamin D, thank you)

Posted by: Sherry at March 24, 2009 04:52 AM

Thanks for the information and the links, Bernard Carroll.

I just wanted to point out that the worst side effect of Zyprexa is death.

Posted by: anonymous at March 24, 2009 06:18 AM

Lilly has balls to re-market Zyprexa and Prozac again, and drag out this old pill too. Will this ever stop?!

What the hell is the FDA? a worthless entity that pumps out drug approvals with reckless abandon! I can't wait to hear Seroquel XR gets approved despite public testimony.

Posted by: Stephany at March 25, 2009 03:51 AM

A number of us emailed in before the deadline to testify at the Seroquel XR FDA Hearing April 8. Guess how many of us have been notified of our "moments to speak"?

Smbyaxx.....2 x 2 = DEATH

Posted by: anonymous at March 26, 2009 11:11 AM

Sigh. Looks as if there is no chance for getting lithobid/Eskalith/lithium off the market even under a supposedly new FDA. I am being contacted by more and more folks with chronic kidney disease from lithium. Please folks, if you ever took it for any amount of time, like a year or more, get your kidney function checked by a blood test now. Some of these folks have been off of it for many years as I was...

Posted by: Alison Hymes at March 26, 2009 03:10 PM
Post a comment









Remember personal info?






pic1.jpg

Winter Fundraiser Underway!!!
Patient Blogs. Sites.
Doctor Blogs. Sites.
Activists. News.
Social Networking. Forums.
Science. Big Pharma. Ethics.
Current Affairs
Seattle Stuff
Smoking. Stuff.

Info
About Furious Seasons
Email
Other Articles
ZYPREXA Documents
Alt ZYPREXA Documents Source
Blakemore-Brown Transcript

 Subscribe in a reader

Recent Entries
Winter Fundraiser, An Early Start
Reasons To Be Skeptical Of "Female Viagra" Drug, Big Pharma's Spanish Fly
Medical Marijuana For Autism?
AstraZeneca Whines About Chicago Tribune's Seroquel Coverage
Big Pharma's Sneaky Trick
Researchers Ignore Problems With Meds In Early Deaths, Blame Smoking, No Exercise
Researchers' New Pediatric Bipolar Disorder Symptoms Include Bed Wetting, Nightmares
Fort Hood Shooting: Was Psychiatrist-Shooter Psychotic Or A Terrorist?
Yale Researcher Links Childhood ADHD To Adult Crime, Drug Dealing
Senator Wants Pentagon To Account For Troop Anti-Depressant Use, Suicide Link
British Government To Limit Antipsychotic Use For Dementia
Child Psychiatrists Behaving Badly With Children
Utah Settles Zyprexa Claims For $24 Million
Psychiatrist Got $490,000 Pimping For Seroquel, Engaged In Wide Off-Label Use
Why Auto Insurance And Health Insurance Aren't The Same, Mr. President
Recent Comments

Alison Hymes on FDA Approves Prozac/Zyprexa Combo Drug For Depression

anonymous on FDA Approves Prozac/Zyprexa Combo Drug For Depression

Stephany on FDA Approves Prozac/Zyprexa Combo Drug For Depression

anonymous on FDA Approves Prozac/Zyprexa Combo Drug For Depression

Sherry on FDA Approves Prozac/Zyprexa Combo Drug For Depression

Bernard Carroll on FDA Approves Prozac/Zyprexa Combo Drug For Depression

Yikes on FDA Approves Prozac/Zyprexa Combo Drug For Depression

Lisa on FDA Approves Prozac/Zyprexa Combo Drug For Depression

Archives
November 2009
October 2009
September 2009
August 2009
July 2009
June 2009
May 2009
April 2009
March 2009
February 2009
January 2009
December 2008
November 2008
October 2008
September 2008
August 2008
July 2008
June 2008
May 2008
April 2008
March 2008
February 2008
January 2008
December 2007
November 2007
October 2007
September 2007
August 2007
July 2007
June 2007
May 2007
April 2007
March 2007
February 2007
January 2007
December 2006
November 2006
October 2006
September 2006
August 2006
July 2006
June 2006
May 2006
April 2006
March 2006
February 2006
January 2006
December 2005
November 2005
October 2005
September 2005
Resources
Mental Health America
National Alliance on Mental Illness
Depression and Bipolar Support Alliance
National Institute of Mental Health
McMan Web
Search


Powered by
Movable Type 3.2