December 31, 2005

Astra Zeneca Asks the FDA to Approve Seroquel for Bipolar Depression

So AstraZeneca, Seroquel's maker, filed papers with the FDA today (er the 30th) to have Seroquel licensed and approved for use in what's called bipolar depression. That's a subtype of the disorder and would be yet another big market for AZ. The two studies they cite as evidence of the drug's efficacy wound up with about 50 percent of patients seeing results over 8-12 weeks while the other half saw no improvement, went off the med, etc. AZ happily notes in its press release that if approved Seroquel would be the only drug approved for both manic and depressive sides of bipolar. That's a sly way of them announcing that if this new licensing is granted then they will market the drug as the new mood stabilizer, a la lithium, Lamictal, etc.

The trouble is that, as many of us know, Seroquel can be a very debilitating drug to live with. I have no trouble with it being used judiciously in short term situations where it is justified, but I am against its long term use. Although the FDA would only technically be approving it here based on shot term studies, it would allow AZ to market the drug with the wink and nod that patients should take it all the time for a lengthy periods as a maintenance drug. The doses they are pointing to as efficacious are 300 mgs and 600 mgs.

Anyone feel like getting juiced on that much Seroquel? Anyone feel like standing by quietly and letting AZ snow the FDA and thousands of doctors who will prescribe anything they see favorably mentioned in a journal article while patients with long-term experience with the drug remain silent? Let's tell the FDA what we think of Seroquel. We need to have our voices heard and our experiences as patients count for something with the very safety officials who are supposed to be looking out for the public.

Let's at least ask them to add cautionary language to the license about its long term use. As far as i know, psych patients have never gotten involved this way before...so this would be a first. (They of course got invovled after the fact with Prozac, Paxil etc.) We need to think of other, future patients and figure out how to help address this situation.

If anyone is down to write the FDA, then reply in comments and i'll do some digging next week and figure out to whom at the agency we can address our concerns--and praise for those of you who want--and i'll let you know what's next. Or reply at the myspace.com bipolar groups.

Sound OK?

For background reading, please read this and this as well as this and this cranky post on Seroquel's lack of efficacy in the very studies AZ cites as proof of its positive qualities. Also, there is this on the ignorance of researchers about the long-term effects of Seroquel and other atypicals on patients' cognition and this post on how the company hype's the drug's balancing abilities.

Posted by Philip Dawdy at December 31, 2005 09:22 AM
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Comments

I'm in. I'm 100% against long term use of this med. There is not enough research and what they do have, quite frankly sucks.

Posted by: kim at December 31, 2005 02:28 PM

cool. that's two of you from here and about five from myspace so far. i want to get this to 15 ppl and then we all work together on what to say...and most importantly how to say it. evidence will count

Posted by: Dawdy at December 31, 2005 02:51 PM

I am a 60 yo bipolar 1 with stage 4 cancer and history of 5 heart attacks and two CABG surgeries.
Needless to say I have concerns about a drug that has been shown to create DVT in elderly patients.

Cardiologist and psychiatrist both give the go ahead on the drug---and 25 mg at night does make me sleep. But I still worry. Sometimes I think worrying is like rearranging the deck chairs---I need to sleep and this drug does knock me out---but since i have sleep apnea and can not use the sleep machine I wonder if the drug will kill me.

I will use 25mg but i will not use it as a maintenance drug---nor will I retrurn to depakote-tegretol or lithium.

Posted by: charles roemer at January 6, 2006 05:17 AM

I hope you don't mind me bringing this old entry back up to the top.

I was reading, and looking at the date and the time.

December 31, 2005 09:22 AM--

This exact moment, due to my daughter turning 18 was being loaded into an AMR for transfer from Children's Hospital to an adult facility, only to return, due to my 13 day aggressive advocacy, to Children's Hospital, where they shot her up straight to 800 mg of Seroquel a day, and she did not sleep for 10 days straight on this drug. (after 6 weeks of increasing dosage)

The doctor was over-conservative, and under aggressive, and wanted to see how the max dose would go, the doctor wanted to allow the drug enough time. Though it was obvious it needed removing.

As the weeks went by, and I begged them to remove the medication per her mania and paradoxical history on medications, they would not hear me.

The doctor told me the last night she was there, that he would write a discharge to the next hospital advising them to change the Seroquel to something else.

He also said this:

"I Do not believe she is suffering."

You tell me, if being locked down hard, manic and no sleep for basically weeks, is not suffering.

Once that drug was removed, it was a rocky road , but the rev up on Seroquel was unfounded, and cruel and inhumane treatment.

These medications are nothing to treat lightly.

Posted by: Stephany at September 9, 2006 07:04 PM

I would love to know more about the downside of this drug as I am currently about to start a clinical study of it for use in Major Depressive Episodes. I exhibit all but one of the symptoms for Major Depression...basically I am not suicidal. Is there something more I should know BEFORE I begin taking this?

Posted by: Cheri at September 13, 2006 09:31 PM

I WAS DIAGNOSED WITH BI-POLAR IN MY EARLY 20'S AFTER TRYING MUCH COCAINE FOR THE 1ST TIME. I WAS PLACED ON HALDOL, TYED DOWN, LOCKED IN A ROOM WHERE ECT'S ARE GIVEN & FELT LIKE BUGS WERE CRAWLING ALL OVER ME. I SCREAMED & SCREAMED IN SHEER TERROR ~ A FEW WEEKS B4 AN 'A' STUDENT IN UNIVERSITY RESUCED TO THIS.
A GUARD CAME IN & TOLD ME THAT IF I DID NOT STOP SCREAMING THAT HE WOULD ZAP ME WITH THE PADDLES IN HIS HANDS. I DID NOT KNOW WHAT THEY WERE AT THE TIME, BUT HE WAS 6 FOOT TALL & THE PADDLES LOOKED LIKED THEY COULD DO SOME DAMAGE, SO I SWALLOWED MY SCREAMS & MY TERROR. I WENT THRU 22 ADMISSIONS & 22 OVERDOSES & NOTHING WOULD KILL ME. MY 1ST ATTEMPT WAS LITHIUM, WHICH PUT ME IN A COMMA 4 3 WEEKS ~ THE DOCTORS TOLD MY PARENTS THAT IF, & THAT WAS A BIG 'IF' AT THE TIME SHOULD COME OUT OF THE COMMA - I WOULD BE IN A VEGATATIVE STATE ~ I AWOKE AS IF NOTHING AT ALL HAD HAPPENED TO ME!
IT WAS NOT MY TIME - AS IT WAS NOT MY TIME ~ THE OTHER 21 TIMES I TRYED ~ BY 24 I WAS IN AA ~ NOT DOING DRUGS OR DRINGING ~ MET A MAN ~ I WAS ON 400MG OF TEGRETOL A DAY ~ HIS FATHER WAS A DOCTOR & HE SAID I DID NOT NEED TO BE ON THIS DRUG ~ SOUGHT A 2ND OPINION ~ THE 2ND DOCTOR TOOK ME OFF OF ALL DRUGS ~ SAID THAT I WAS AN ALCOHOLIC ~ HAD A DIFFICULT CHILDHOOD ETC. ~ THE DOCTOR SAID THAT I HAD BEEN MISDIAGNOSED ~ THAT I WAS NOT BI-POLAR ~ FOR 10 YEARS I ENJOYED LIFE WITHOUT THE STIGMA OF MANIC DEPRESSIVE ILLINESS CLOUDING MY LIFE ~ I CHANGED CITES DUE TO AN ABUSIVE BOYFRIED ~ BECAME MANIC ~ PUT BACK ON MEDS ~ HOSPITALIZED~
I HAD THE BEST DOCTOR IN THE WORLD WITH DR. R. STEINER @ THE MONTREAL GENERAL IN MTL. HE KEPT ME ON A MINIMUM OF MEDS ~ ONLY RAISING THEM WHEN NESCESSARY ~ USUALLY SEEING ME THE SAME DAY ON WHICH I FELT MANIC ~ SO THERE WAS NO DOWN TIME ~ I DID NOT THINK OF MY DISEASE MUCH.
I MOVED TO TORONTO~ BIGGEST MISTAKE OF MY LIFE ~
I COULD NOT FIND A DOCTOR WHEN I 1ST CAME HERE & BECAME MANIC DUE TO THE CHANGE. I HAD TO FLY BACK TO MONTREAL TO BE TREATED. IN THE PAST 8 YRS THAT I HAVE BEEN IN TORONTO I HAVE BEEN ILL VERY OFTEN & FOR VERY LONG PERIODS. I WAS JUST IN THE MIDDLE OF A MEDICAL COURSE OF STUDY & HAVE HAD TO DROP OUT UNTIL I AM WELL. ALL THE WHILE TERRIFIED THAT SOMEONE WILL FIND OUT THAT I SUFFER FROM BIPOLAR. THIS WORRY IN ITSELF IS ENUOGH TO MAKE ANYONE SICK.
MY DOCTOR ALTHOUGH A VERY PLEASANT LADY DOES NOT KNOW THE MEANING OF THE WORDS " LETS REDUCE SOME OF THESE DRUGS THAT YOU HAVE ME ON, I AM WELL NOW. SHE NEVER DOES & THEN I FALL ILL & I AM ON A WHOLE LOT OF DRUGS & I AM NOT GETTING BETTER & HAVE GAINED 20 POUNDS IN LESS THAN A MONTH, SUFFER FROM BLACKOUTS, I AM VERU SUICIDAL RIGHT NOW, COMES & GOES,.... PRESENTLY ~ I SUFFER FROM BROCHOTIS ( SINCE THE LAST MONTH - 3 ROUNDS OF ANTIBIOTICS - STILL SICK) BROKEN OR SPAINED ANKLE, 30 LBS OVER WEIGHT, THYROID NODULES UNDER INVESTIGATION, & I SLICE MY THUMB ON THE WEEKEND & DIDN'T GET STITCHES WHEN i SHOULDA.
I PRESENTLY TAKE:
600MG LITHIUM
200MG SEROQUOL
3 MG RIVITROL
500MG TEGRETOL
7.5 IMOVANE
5MG ZYPREXA
30MG TEMAZEPAM
50MG TOPIRAMATE

I HOPE THIS DOCTOR HAS STOCK IN THESE DRUGS, BECAUSE THEY CERTAINELY ARE NOT DOING ME ANY GOOD, IF ANYTHING THEY HAVE MADE ME THE WORST THAT I HAVE EVER FELT BOTH PHYSICALLY & MENTALLY.

Posted by: Colleen at May 10, 2007 10:14 AM

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