March 03, 2009

FDA Panel To Review Seroquel Approval Due To Weight Gain, Blood Sugar Issues

As I mentioned last week, the FDA's psychopharmacology advisory panel is going to review the possible approval of Seroquel for three depression indications and anxiety in early April. My hunch was that the clinical trials must be producing loads of fat, high-blood sugar patients, especially since one of the depression indications for which approval is being sough is for "maintenance," meaning long-term use.

Reuters is out today with a brief note on the April 8 hearing:

"The issues for discussion at the April 8 meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," an FDA meeting notice said.

"Tardive dyskinesia causes involuntary, repetitive movement of the limbs and lip smacking, grimacing and other symptoms."

I'm glad the FDA is paying attention to these issues, but I don't have much confidence in the psychopharm panel as it's stacked with psychiatrists and the lone consumer rep--Gail Griffith--is a big time NAMI-ite.

But who knows? Perhaps, I'll wind up surprised.

Posted by Philip Dawdy at March 3, 2009 11:29 AM
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Comments

Don't forget Seroquel also causes diabetes!

Posted by: grat at March 3, 2009 11:47 AM

Does anyone know if this is an Open Public Hearing or not? If there are testimonies from the public it could get interesting and we should fund Philip to get there and give his two cents worth!

Posted by: Sara at March 3, 2009 11:58 AM

Philip,

I hope the panel discusses serotonin syndrome as it relates to Seroquel. The following is a list of meds that can cause serotonin syndrome, especially when added to an SSRI. Then, after this article, there are two articles [partially copied] which show stats for serotonin syndrome. These were taken from www.SSRIstories.com

In 2002 there were 93 serotonin syndrome deaths reported by the CDC. In 2004 there were 103 deaths reported and in 2005 there were 118 deaths reported from serotonin syndrome.

http://www.bestsyndication.com/?q=050507_seratonin-issue-over-prescribed-anti-depressant-medications-with-children-bad-outcomes.htm


The following are some of the products known to be associated with serotonin syndrome:

Monoamine oxidase inhibitors (MAOIs)
Tricyclic antidepressants (TCAs)
Selective serotonin reuptake inhibitors (Zoloft, Prozac, Paxil, Lexapro, Celexa)
Venlafaxine (Effexor)
Trazodone (Desyrel)
Nefazodone (Serzone)
Meperidine (Demerol)
Dextromethorphan (Cold Remedies)
Chlorpheniramine
Sumatriptan (Imitrex)
Atypical antipsychotic (Zyprexa, Risperdal, Seroquel)
L-dopa
Meridia
Lithium
Valproic acid (Depakene)
Linezolid (Zyvox)
St John's Wort
Ginkgo Biloba

Many experts blame the rise in cases of serotonin syndrome on the fact that so many different drugs are being prescribed to patients at the same time in combinations, or "drug cocktails," which have never been approved as safe and effective by the FDA for any use and without considering the over-the-counter medications that patients may be taking.

------------------------------------------------------------------------------------------------------------------------------------------------------

http://www.ssristories.com/show.php?item=1624

Paragraph 4 reads: "In their review in The New England Journal of Medicine, Dr. Boyer and Dr. Shannon cited a report based on calls to poison control centers around the country in 2002 showing 7,349 cases of serotonin toxicity and 93 deaths. (In 2005, the last year for which statistics are available, 118 deaths were reported.)"

Paragraph 3 reads: "Now, with the enormous rise in the use of serotonin-enhancing antidepressants, often taken in combination with other drugs that also raise serotonin levels, emergency medicine specialists are trying to educate doctors and patients about this not-so-rare and potentially life-threatening disorder. In March 2005, two such specialists, Dr. Edward W. Boyer and Dr. Michael Shannon of Children’s Hospital Boston, noted that more than 85 percent of doctors were 'unaware of the serotonin syndrome as a clinical diagnosis.' ”

http://www.nytimes.com/2007/02/27/health/27brody.html?em&ex=1172638800&en=9287fb6bfa45cbc6&ei=5087%0A

A Mix of Medicines That Can Be Lethal
By JANE E. BRODY
Published: February 27, 2007


http://www.ssristories.com/show.php?item=2944

First 2 sentences of paragraph 3 reads: "The Toxic Exposure Surveillance System reviewed cases from office-based practices, inpatient settings, and emergency departments and found that during 2004, selective serotonin reuptake inhibitors (SSRIs) caused significant toxic effects in 8187 persons, leading to 103 deaths.[1] The true incidence of serotonin syndrome and associated morbidity are likely to be much greater."

http://www.medscape.com/viewarticle/582862

-------------------------------------------------------------------------------------------------------------------------------------------------------------


How Common or Significant Is Serotonin Syndrome?
Posted 11/10/2008

Joel Lamoure, RPh, BSP, FASCP
Author Information



Posted by: Rosie at March 3, 2009 12:13 PM

For maintenance?

I wonder why I get sad sometimes. Taking Effexor and 200 mg Seroquel...
Shouldn't I be jumping of joy?
I wish that the neoliberalism was over a decade ago or I could fast forward some decades and take a glimpse how will pharmas will maintain their power.
I'm bored today.
It's not normal for someone who is taking all these drugs.
Should I report it to FDA?
Dear Sirs,
I currently taking X, Y and Z drugs and I'm feeling great as you've been describing and reporting repeatedly these drugs works.
However today I'm feeling a little bored.
What am I supposed to do?
Sincerely yours,
Ana

Dear Ana,
We are glad to know that you are not that crazy. We believe you should ask you physician or go to any other to increase your dose.
Sincerely yours,
Food and Drug Administration
FDA

Will they split or not?

FA and FD... sounds nice.

I hope Philip is in a good mood. I hope I'm not bothering anybody. I only do it when things are calm... Just to try to put a smile on Philip's face. Can you imagine dealing with all these the way he does?
You are a very special person Philip Dawdy.

Posted by: Ana at March 3, 2009 02:39 PM

What is serotonin syndrome? I feel I should know. But I don't.
TIA

Posted by: Sherry at March 3, 2009 05:46 PM

What is Serotonin Syndrome? Here's info on poison control from a center in Utah.
http://uuhsc.utah.edu/poison/healthpros/utox/Vol4_No4.pdf

Posted by: Lilly NC at March 3, 2009 10:36 PM

Really really bad serotonin syndrome described in Pubmed: see http://www.ncbi.nlm.nih.gov/pubmed/15027311

Posted by: Lilly NC at March 3, 2009 10:48 PM


Re: Psychopharmacologic Drugs Advisory Committee on Seroquel XR to be held on April 8, 2009




Sara asked, “Does anyone know if this is an Open Public Hearing or not?”




Yes, data may be presented in writing or in person. Additional information is posted here:
http://www.fda.gov/cder/audiences/acspage/meetings/pdac_meeting_20090408.htm




Contact information:
Yvette Waples
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093)
Rockville, MD 20857
Phone: 301-827-7001
FAX: 301-827-6778
Email: yvette.waples@fda.hhs.gov




FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512544




The regulations on public hearings before a public advisory committee are posted here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=14&showFR=1


Posted by: Nancy Fruge at March 7, 2009 08:36 AM

Thanks so much, Nancy Fruge, for relaying that information. Now are there any readers of this site prepared to step up and go? I can tell you that it does make a difference to testify at these hearings. At the very least consider submitting something in writing. It's handed out to all the committee members as far as I understand. Whether they read it or not isn't always obvious but if they have a conscience they will. Say what you have to in ways that can be heard rather than with great hostility even if that is how you feel.

Posted by: Sara at March 7, 2009 12:42 PM

Thanks for the references about seratonin syndrome. Basically, it's strictly an iatrogenic disorder, right?

So much for "do no harm".

Posted by: Sherry at March 7, 2009 04:16 PM
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