Navigation Links
FDA Panel Snubs Seroquel as 1st Choice Depression Treatment
Date:4/8/2009

Safety concerns mean the drug should only be used when other medications don't work, advisers say

WEDNESDAY, April 8 (HealthDay News) -- In a unanimous vote, a U.S. Food and Drug Administration advisory panel determined Wednesday that AstraZeneca's antipsychotic drug Seroquel has too many safety concerns to make it a first-line treatment against depression or anxiety disorders.

However, in a separate 6-to-3 vote, the panelists recommended that the medication could be used as supplemental treatment for patients with depression who do not get symptom relief from other drugs, the Associated Press reported. The expert panel did not hold a similar vote for anxiety disorders.

Overall, "I saw no clear advantage demonstrated in efficacy," said Dr. Wayne Goodman, the panel's chairman and a psychiatric researcher at the U.S. National Institutes of Health. "There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug."

The FDA is not mandated to follow its advisory panels' advice, although it usually does. Federal health officials have already approved the use of Seroquel (quetiapine) and drugs like it to treat schizophrenia and bipolar disorder.

Wednesday's decision, by a panel of psychiatric experts, follows a study released earlier this year that suggested that newer, second-generation antipsychotics such as Seroquel might pose heart risks -- specifically, a higher risk of sudden death due to cardiac arrest. The study was published in the Jan. 15 issue of the New England Journal of Medicine.

At the time, experts said that the overall odds of a heart problem for patients taking this class of medications -- which also includes clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperdal) -- were probably low, and the drugs remained appropriate for certain patients. Still, doctors, families and patients should be cautious, according to the study's lead author, Wayne Ray, director of the Vanderbilt University School of Medicine's Division of Pharmacoepidemiology.

"If they're being used for schizophrenia, consider a cardiology evaluation. If you're considering using them for bipolar disorder, think about using another alternative drug first," Ray told HealthDay in January.

And patients should rarely, if ever, take the drugs to treat other conditions, he said. However, doctors have also prescribed them for so-called "off-label" uses to treat conditions such as anxiety, attention deficit disorder in children and dementia in the elderly.

"For schizophrenics, they work pretty well. They're pretty much the only alternative," Ray said. But other drugs offer alternatives for bipolar patients, he noted.

In their study, Ray and his colleagues expanded on earlier research that suggested the newer drugs disrupt the heart's rhythm. The team found that users of the newer drugs were 2.26 times more likely to suffer from sudden cardiac death than those not on the medications. Those who used the older drugs were 1.99 times more likely to die versus those not taking the medications.

The drugs appear to cause problems by disrupting potassium in the heart, causing its electrical rhythm to fail, Ray said.

In a statement released Wednesday, Dr. Howard Hutchinson, chief medical officer of AstraZeneca, which makes Seroquel, said the company was "pleased" that the panel found Seroquel appropriate as adjunctive therapy for depression.

Acknowledging that the panel "had concerns around the long-term safety profile in these new populations," Hutchinson said that he and his colleagues "look forward to having further discussions with the FDA" regarding the new drug applications.

In the meantime, AstraZeneca is fending off claims from thousands of former Seroquel users that the U.K.-based drug maker held back data on the drug's risks, according to the Associated Press. Seroquel's labeling now alerts users to heightened risks for high blood pressure, diabetes and death.

More information

There's more on the newer class of antipsychotic medications at the U.S. Food and Drug Administration.



SOURCES: April 8, 2009, statement, U.S. Food and Drug Administration; April 8, 2009, news release, AstraZeneca; Associated Press; Wayne Ray, Ph.D., director, Division of Pharmacoepidemiology, Vanderbilt University School of Medicine, Nashville; Jan. 15, 2009, New England Journal of Medicine


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Snubs Seroquel as 1st Choice Depression Treatment
(Date:12/2/2016)... ... December 02, 2016 , ... For over twenty-four years, Doctors on Liens ... personal injury victims find high quality medical care. When the company started in 1997, ... Fast forward to present day and the now ten-page directory features a vast array of ...
(Date:12/2/2016)... ... ... Center for Autism and Related Disorders (CARD) Portland today announced plans to host ... other developmental disabilities. The group, which is being launched with the help of Robbie ... share stories and advice, seek help, and continue their education on how to best ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet’s ... ostomy patients, standing as living proof that attitude and determination can combine into ... issues that spike around the holidays. This campaign will offer patients a new-found ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... of its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite helps biobanks, clinical, research and ... storing, shipping and disposal. The new version is a faster and a more ...
(Date:12/2/2016)... ... ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), a unique wearable technology that measures ... on the market can deliver all that rejiva can. , “Rejiva promotes relaxation and ... than the usual heart rate and steps taken”, adds Evens Augustin, CEO of Rijuven. ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... Dec. 2, 2016  Maxor National Pharmacy Services, LLC ("Maxor"), ... Specialties, Inc. ("PSI").  The combination of Texas ... -based PSI bring together both company,s clinical expertise and ... payers an industry-leading specialty pharmacy. About Maxor ... , , ...
(Date:12/2/2016)... MARLBOROUGH, Mass. , Dec. 2, 2016 ... announced a definitive agreement to acquire certain manufacturing assets ... NVCN ) (TSX: NVC) advanced biological tissue business, as ... a total of $75 million in cash. The Neovasc ... heart valves, including the Boston Scientific Lotus™ Valve System. ...
(Date:12/2/2016)... MONMOUTH JUNCTION, N.J. , Dec. 2, 2016 /PRNewswire/ ... critical care immunotherapy leader commercializing its European Union approved ... in critically-ill and cardiac surgery patients worldwide, announced that ... present at the 9th Annual LD Micro Main ... 8 th , 2016 at the Luxe Sunset Boulevard ...
Breaking Medicine Technology: