March 03, 2009FDA Panel To Review Seroquel Approval Due To Weight Gain, Blood Sugar IssuesAs 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. 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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Don't forget Seroquel also causes diabetes! Posted by: grat at March 3, 2009 11:47 AMDoes 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 AMPhilip, 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
Monoamine oxidase inhibitors (MAOIs) 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
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 -------------------------------------------------------------------------------------------------------------------------------------------------------------
Joel Lamoure, RPh, BSP, FASCP
For maintenance? I wonder why I get sad sometimes. Taking Effexor and 200 mg Seroquel... Dear Ana, 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? What is serotonin syndrome? I feel I should know. But I don't. What is Serotonin Syndrome? Here's info on poison control from a center in Utah. 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:
Contact information:
FDA Advisory Committee Information Line
The regulations on public hearings before a public advisory committee are posted here:
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 PMThanks 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 PMPost a comment
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