December 31, 2005Astra Zeneca Asks the FDA to Approve Seroquel for Bipolar DepressionSo 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
del.icio.us
Digg it
reddit
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 PMcool. 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 PMI am a 60 yo bipolar 1 with stage 4 cancer and history of 5 heart attacks and two CABG surgeries. 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 AMI 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 PMI 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 PMI 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. 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. |
Patient Blogs. Sites.
The Trouble With Spikol
Icarus Project Blog John's Bipolar Stories Seroxat (Paxil) Sufferers Stand Up! Seroxat (Paxil) Secrets The Bipolar View Writhe Safely soulful sepulcher Electro Boy Spiritual Emergency Mental Nurse Deborah Gray Mental Mommy The Splintered Mind bipolar.and.me Nurse Ratched Psych Person Trick Cycling for Beginners depression introspection Salted Lithium Living With A Purple Dog Polar Trippin' Mercurial Scribe Bipolar Chicks Blogging Bipolar Blast Off Label Jung At Heart Graphic Truth Joysoup Apesma's Lament Soapy Water Outlaw Psychiatry Empirical Insanity Patient Anonymous Beyond Blue Psych Survivor Postpartum Progress The Happiness Project Finding Optimism The Gimp Parade Midlife and Treachery Secret Life of a Manic-Depressive Psych Tech Going Through Hell
Doctor Blogs. Sites.
Clinical Psych
World of Psychology CorePsych The Last Psychiatrist Carlat Report Blog Intueri Emotional Well-Being Scientific Misconduct Aaron Beck Cognitive Therapy Today Treatment Online Shrink Rap David Healy Dr. Dork NHS Blog Doctor Dr. X's Free Associations Dr. Sanity Anxious Mind Everyone Needs Therapy Counselling Resource
Activists. News.
Charlottesville Prejudice Watch
The Icarus Project MindFreedom AHRP Blog SSRI Stories Healthy Skepticism Psych Rights Treatment Advocacy Center Peter Breggin Schizophrenia News eDrugSearch Blog Nuts R Us News Disapedia WSJ Health Blog
Social Networking. Forums.
Mood Garden
Paxil Progress Crazy Boards Forums Psych Central Forums Icarus Project Forums DepressionTribe MySpace Bipolar Group Bipolar World Pendulum.org Bipolar Planet About.com Bipolar
Science. Big Pharma. Ethics.
PharmaLot
Pharma Gossip Science Blogs Mind Hacks GoozNews Integrity in Science Neurophilospohy bioethics.net Drug Wonks Pharma Marketing Blog Pharma's Cutting Edge On Pharma Health Care Renewal
Current Affairs
Buzz Machine
To The People Andrew Sullivan Michelle Malkin Daily Kos Reason's Hit&Run The Agitator Press Think Jim Romenesko Rough Type Gawker The Graphic Truth Tail Rank Huffington Post Instapundit Little Green Footballs Talking Points Memo MoJo Blog
Seattle Stuff
Smoking. Stuff.
|

