According to the FDA Web site, the extended release formula for quetiapine fumarate, Seroquel XR, was approved on May 17, 2007. The statement "Label is not available on this site" appears where the new drug label should have been posted. The new label was elusive on the company's Web site as well. Why weren't the approval documents posted?

Subsequent updated drug labels stated that Seroquel XR consisted of quetiapine fumarate, however the committee hearing documents stated that Seroquel XR consisted of quetiapine maleate. It appears that studies of Seroquel SR (quetiapine fumarate, sustained release) were used to support the approval of Seroquel XR (quetiapine maleate, extended release). This does not make sense to me.

A document on the FDA Web site indicates that Seroquel SR (quetiapine fumarate) was changed to Seroquel XR during the approval process. This action created a discrepancy between the drug information posted on ClinicalTrials.gov and the drug information published in scientific journals. When the discrepancy was pointed out to the company in December 2008, the following statement was added to study descriptions in the ClinicalTrials.gov database: "PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA."

So which drug formula was tested in the clinical trials, quetiapine fumarate or quetiapine maleate? Interestingly, the FDA committee meeting brief described the drug as quetiapine maleate. On the other hand, the company’s brief described the drug as quetiapine fumarate. What’s the story on this discrepancy? Maybe this is the reason the approval documents were never posted on the FDA Web site. The company may not want the public to know that the formula was changed. But why?

Aside from the mysterious changes in the name and the formula of the drug, if quetiapine is the only drug that works for an individual, why not use the immediate release form, which is easier to titrate? Consider the clinical trials data (consider the source as well), drug price, potential for generics in the future, and the underutilization of nonpharmacological therapies. There is NO compelling reason to justify adding Seroquel XR to the armamentarium of treatments for depression and anxiety.

Good point, Anonymous. The 4-4-1 split on the Advisory Committee re using Seroquel Whichever for MDD monotherapy was NOT left unchallenged by Dr. Temple, who tried his darndest to get at least one person to change over to "yes" to give him a majority. Every member held up against his badgering questions. For that, especially for that, I thank the committee for holding the line, because MDD monotherapy is the one Astra Zeneca wanted the most.

Now let's see whether Temple/FDA change the rules anyway despite the hours upon hours of hearings that took place.

RECALL info from the FDA:
PRODUCT
Seroquel XR (quetiapine fumarate) extended-release tablets, 50 mg, Once Daily, Professional Sample, supplied in four tablet blister card, NDC 0310-0280-94. Recall #D-233-2009 CODE
Lot number: TA5014
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca Pharmaceuticals, by letter dated *MARCH 6, 2009*. Firm initiated recall is ongoing.
REASON
The incorrect Product Insert (Prescribing Information) was included with shipments of Seroquel XR 50mg samples.
VOLUME OF PRODUCT IN COMMERCE
255,953 blister packs
DISTRIBUTION
Nationwide

THe FDA should look into direct to consumer advertising like this:

http://i42.tinypic.com/o7mw03.jpg

As much as I liked your PT interview, there are Seroquel ads all over their site, as well. You can't tell me it doesn't cloud their judgment.

Actually, the Hearing was such a depressing event that I thought for a moment I might need a Seroquel pill to get me through it. Fortunately, I was flanked by my friends Kim W. and Allen J., and the vet families sat right behind us, so I was surrounded by support. I was even thinking of screaming and being ejected (there are now formal Rules of Conduct for these Hearings).

In reflecting on the experience, I realize this is the very first time I can recall an atypical coming into the full limelight of the Psychopharm. These horrible killer drugs have been on the market since '96, '97 - Clozaril even earlier as it went first. It meant alot that SSRI fighters were also in the room with me. I have always tried to be in the room with them when the chips were down, particularly the hearing in 2006.

I was put on Seroquel as a teenager for anxiety. I was also put on Risperdal and Abilify as a teenager for anxiety. Now the FDA doesn't approve it. Doctors will prescribe off label anyway, to kids and teenagers so the FDA doesn't make a difference I was on Seroquel for two years for anxiety as a teenager. However, it was not as bad as Risperdal and Abilify, which I was on as a young teenager for anxiety. I wish I could show this to my old doctors and ask them why they put me on that stuff. This makes me really upset.

I was extremely saddened in the fact that the veterans who have died while taking this drug were overlooked in the news. A list of over 80 Iraq veterans was presented with names being read and yet the AP or any other news medica did not take latch to this information. More amazing was three of the public speaking familes where these deaths occured are all from the same area. Peanut butter deaths shut down factories and are pulled from shelves, but not when our own veterans die...shame!

The only article I've found that actually mentions the speaking of the vets' families at the Hearing yesterday was written by Miriam Hill of the Phila. Daily Inquirer. Try philly.com

Though it was on the business pages, Ms. Hill at least talked to the families and wrote something about them. Every other article I have seen...incl. Forbes, wsj, Reuters, etc. has only the bottom line news, and ALL the articles were in the business sections. SHAME

Another reminder that Seroquel is risky for elderly patients:

http://www.cantonrep.com/lifestyle/advice/x549599289/Family-Doctor-Patient-given-inappropriate-medication

Psychiatrists speak out about atypical antipsychotics in "Atypical antipsychotics: too hard a sell?" Los Angeles Times:

"The story's pretty clear, and pretty embarrassing for the profession of psychiatry, which has allowed itself to be led by marketing," says Robert Rosenheck, a psychiatrist at Yale University who has studied the effectiveness and expanded use of the atypical antipsychotics. "We know now what these companies' strategies are: The number of people with schizophrenia is limited, so the road to profitability goes through soccer moms. They need to market these drugs to ordinary people who have dissatisfactions in life."

http://www.latimes.com/features/health/la-he-antipsychotics13-2009apr13,0,2324987.story

A brand-new effort by Astra Zeneca is coming up in June, when it asks the Psychopharm. Advisory Committee for permission to recommend the FDA to LEGALLY GIVE SEROQUEL TO ADOLESCENTS AND CHILDREN. AGES AND CATEGORIES NOT KNOWN BY ME AT THIS MOMENT.

I JUST HOPE AND PRAY that the new heads of the FDA, DRS. Hamburg and Sharfstein, are at the helm by then and that a new broom has swept clean the years of abuse and death and harm done to the American public by atypical antipsychotic and other psychotropic drugs for the sake of greed alone.