April 08, 2009

FDA Panel Approves Seroquel As Add-On Depression Treatment

News is just out that the FDA's psychopharmacology advisory panel has recommended that the agency approve Seroquel, an atypical antipsychotic, as an add-on or adjunctive treatment for depression, meaning to be taken in addition to anti-depressants. It recommended against approval as a monotherapy for depression and as a maintenance treatment for depression and as a treatment for anxiety. The recommendations now go to the full agency, which is not bound by them, for a final determination, likely in the near future.

"Several panel members stressed that doctors should try other medicines for depression first before deciding to add Seroquel XR.

"'I think this represents a second-line therapy,' said panel member Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana.

"The FDA asked the panel to weigh wider use of the drugs versus known side effects including weight gain and tardive dyskinesia, a movement disorder that causes jerking. A recent study also raised concern about sudden deaths of patients taking atypical antipsychotic drugs including Seroquel."

I hope the agency grows a pair and declines to approve the drug for any new indications.

Posted by Philip Dawdy at April 8, 2009 01:47 PM
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Comments

That sucks. How did Griffith and Lawrence vote I wonder? As an adjunct to antidepressants, I believe it will increase the risk for the onset of serotonin syndrome which many medical professionals don't even recognize when symptoms are staring them in the face. How can it possibly be safer in conjunction with an antidepressant than by itself? To be honest, I don't get it. I guess it's that "treatment resistant" depression you get when antidepressants don't make you "better than well" and somehow getting stoned on Suzie-Q makes it all not matter.

Posted by: Sara at April 8, 2009 02:19 PM

Un-fucking-believable! The FDA is recklessly endangering lives and what a quack of an endo-doc to promote this neuroleptic!

I knew this would happen, our country is bought and paid for by pharmaceutical companies, they lobby congress, the FDA has conflict of interest (Laughren, et al), and all of this while Seroquel is the product in litigation for death and diabetes!

The FDA cannot be trusted, take drugs approved by them at your own risk!

Posted by: Stephany at April 8, 2009 02:21 PM

BREAKING NEWS FROM THE FDA PhARMA FUNDED FAST TRACK:

In this fixed one pony race; Pharma buys another victory without even breaking a sweat or mounting the jockey on their biting donkey; even after the FDA brought in the hand selected B-Team to do Pharma's bidding.

Who loses? Of course the American public loses, potential patients lose big time, yet in the end the Biggest LOSER is the FDA that has now showed itself to be as corrupt and defunct as Pharma itself.

The saddest part of this whole crazy scenario is that once the government loses the public trust, it in all reality can no longer govern those under its leaky umbrella. A silent revolution has begun, and our government is either purposely blind or just showing whole sale ignorance to the people they once represented.

RIP - FDA - April 8, 2009

They died a just death for all to see. Now the deceased FDA is just a hollow theocracy dead and buried in greedy blatant corruption.

Posted by: FDA DID WHAT at April 8, 2009 02:44 PM

We have examples of this add-on treatment where combining Seroquel with an SSRI, usually either Paxil or Prozac, caused the death of an unknown number of soldiers. They probably died from serotonin syndrome.

A FATHER whose soldier son died in his sleep on a combo of Seroquel and Paxil did investigate and found about 12 more soldier deaths in his state of North Carolina and Kentucky, Ohilo and West Virginia..

What we need instead of more drug ads and more add-on treatments are more FATHERS.

Here is the article on the 12 dead soldiers - almost all in their 20's we died in their sleep while on a combo of Seroquel and an antidepressant.

http://www.ssristories.com/show.php?item=2608

Posted by: Rosie at April 8, 2009 02:47 PM

"Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana."

Have to wonder if he's running the Lilly study for Byetta there? That touted diabetes wonder drug with soon to be new FDA label warnings of deadly pancreatitis side effects.

Posted by: Question at April 8, 2009 03:09 PM

I think Dr. Greenway is looking forward to Seroquel causing obesity and bringing him business. A quick search of him reveals;

2008
Principal Investigator Dr. Frank Greenway, MD, has received FDA approval to begin human clinical Phase I studies… "The development of novel anti-obesity therapies has been a focus of my research for 30 years and I am excited to continue that commitment in collaboration with Compellis Pharmaceuticals," said Dr. Frank Greenway.

http://www.medicalnewstoday.com/articles/93456.php

1994
Dr. Frank Greenway is getting more than his share of media attention these days, and it has little to do with his medical practice. Greenway, a Los Angeles endocrinologist, is becoming known as the virtual guardian angel of women suffering from "thunder thighs."

http://www.thefreelibrary.com/Local+inventors+bask+in+the+glow+of+media+spotlight%3b+thigh-reduction+...-a015349195

Posted by: In Tears at April 8, 2009 04:51 PM

Being there ---- met the families last night. Overwhelming. This is the FIRST real referendum on the atypicals. Laughren and Temple orchestrated the whole shebang. If I'd been on antidepressants, well...won't say what I felt like doing.

The OPEN PUBLIC SPEAKERS WERE EXCELLENT; best I've EVER HEARD. MUCH PRESS. One family lost TWO sons - one to the "magic cocktail" and the other to the Iraq War.

Saw rows of ASTRAS staring at me after my testimony so I STARED BACK AT THEM WITH UNWAVERING EYE CONTACT.

TOTALLY DISGUSTING SCENARIO. Fortunately surrounded by old and new friends as we gave each other strength and swore under our breath.

TIME FOR THE BIGGEST GUNS TO COME OUT AND SMITE THE DEVIL OF GREED and DEATH

Posted by: Anon. at April 8, 2009 04:53 PM

Barbara Geller, Child and Adolescent Bipolar Foundation advisory panel was a temporary voting member/

Posted by: Stephany at April 8, 2009 05:39 PM

Vote tallies - MDD as adjunctive tx - 9 yes, 1 no (Kelsey) question 1a. Question 2a GAD adjunct 6 yes, 3 no, - Lawrence and Harrington no Next ? - GAFD as monotx 7 yes 2 no . Question vote for BROAD USE MDD 0 yes, 9 no and for GAD monotx for BROAD use - 0 yes, 9 no. Final Question , #4 - "Acceptally safe in ..certain instances (not defined) .....MDD was 4 yes, 4 no, 1 abstention GAD 2 yes, 6 no, 1 abstention. Questions posed for voting kept being manipulated by Laughren and Temple. Temple PUSHED to change the 4-4-1 vote to tip it over into the YES column but everyone held their ground....of course now the FDA gets the final play...

Posted by: Anon. at April 8, 2009 06:44 PM

I have posted somewhere else on FS abt this faux advocacy group, "child and adolescent bipolar foundation" - where i found their annual budget (half million), and found their budget line on plain old fundraising (about 500 bucks). You be the judge and figure out where the budget for this advocacy group comes from. that just does not seem like an impartial mom to me. i feel bad for whatever problems her child has - but ppl - let's stop giving these kids iatrogenic problems on top of it all.

Posted by: MedsVsTherapy at April 8, 2009 09:34 PM

I blogged abt part of the AZ data 'supporting' this fda review. that entry has a link to one of the bits of info.

http://www.medsvstherapy.com/2009/04/spin-change-seroquel-risky-for.html

Posted by: MedsVsTherapy at April 8, 2009 09:38 PM

The parents who were there and testifying - having lost two sons; one to Iraq and the other to the Seroquel cocktail - want help. Contact Stan White, Advocate for Veterans with PTSD. Stan's email address: hswhite2346@yahoo.com

The Whites spent two days in D.C.; one at the hearing and one visiting legislators.

Posted by: Anon. at April 9, 2009 02:51 AM

CABF has significant pharma funding, and Joseph Biederman as a professional advisory panel member. The group promotes drugging children, and has long before any drug such as Abilify and Risperdal were approved for use in kids.

I was told in email by Barbara Geller, another CABF professional advisory panel member and a temporary voting member on the FDA committee that I should give my daughter antidepressants to "prove she is bipolar" and that was nearly a decade ago.

CABF has a highly influential professional advisory board, and bpkids dot org promotes parents drugging their child. I was told quite often during the years my daughter suffered a misdiagnosis and drugging for bipolar at age 11 that if she went off drugs she would kill herself by age 18. CABF also uses psych meds as a comparison to using chemo treatment for cancer.

Rebecca Riley, age 4 died from that kind of treatment. My daughter is disabled from that kind of treatment.

Posted by: Stephany at April 9, 2009 03:54 AM

Actually, it was RIP to FDA in November of 2000. Waxman, when he was in the minority, did a great study of how the warnings from FDA to pharma plummeted from the moment W "took the reigns".

Posted by: Anon. at April 9, 2009 07:26 PM

Actually, it was RIP to FDA in November of 2000. Waxman, when he was in the minority, did a great study of how the warnings from FDA to pharma plummeted from the moment W "took the reins".

Posted by: Anon. at April 9, 2009 07:26 PM

Anon. above, you are right. I saw that Waxman Study of FDA warnings plummeting - tracked, I believe from 2000 to 2005. If you check out FDA current website, voila!!!! All of a sudden there are 14 WARNINGS. I am sure this has nothing to do with new leadership at the White House.

Posted by: anon at April 13, 2009 07:17 AM
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