Navigation Links
Doctors raise questions, concerns about FDA suicide warning
Date:12/9/2008

SEATTLE, December 8, 2008Medical specialists at the nation's largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency's analyses on clinical practice and the way AED drug trials are to be conducted in the future.

It is well known that non-adherence to antiepileptic drug therapy can lead to a dramatic increase in accidents and deaths. For these reasons, epileptic experts believe it is imperative that patients continue their antiepileptic therapy to prevent the occurrence of serious accidents and death.

During the American Epilepsy Society's annual meeting, epidemiologists, epileptologists and psychiatrists offered a critical review of the FDA's methodology and analyses, describe the suicide alert's potential impact on patient compliance and seizure management, and its likely effect on the selection of patients for AED regulatory studies.

Among the doctors' concerns is that news reports of the FDA's analyses have confused patients and, perhaps, some physicians on the risks associated with epilepsy drugs. They cite data showing that the risk of suicide possibly associated with AEDs is extremely small compared to the potential danger of leaving patients untreated. Also of concern is that epilepsy patients prone to suicidal ideation or behavior will be excluded from clinical trials of new AEDs.

The panel is seriously concerned about methodological flaws in the FDA's data collection and analysis, including biased measurement of suicidality and exclusion of a large proportion of the data. The FDA performed similarly flawed analysis of the SSRIs. After the black box warning appeared, there was a decrease in use of the SSRIs with a corresponding increase in suicide, contrary to what the FDA's conclusions would predict.


'/>"/>

Contact: Peter VanHaverbeke
pvanhaverbeke@aesnet.org
703-927-9639
American Epilepsy Society
Source:Eurekalert

Page: 1

Related medicine news :

1. Mega Pediatric Group Allows Doctors to Focus on Patient Care as the Business Side of Private Practice Becomes More Difficult to Sustain
2. Doctors Issue New Neuropathy Test Guidelines
3. LA BioMed researchers among Southern California Super Doctors
4. Doctors Go Viral: vSling Video Testimonial Tool Offers Doctors Access to New Channels for Acquiring Patients
5. Blue Cross/Blue Shield Christmas Gift to Federal Employees: Surprise, Were Cutting Your Benefits!; Patients, Doctors and Health Care Providers Outraged
6. Doctors Receive Bonuses for Providing Optimal Care to Patients Through Bridges to Excellence
7. Medical Mystery, 8-Year-Old Hussein Balhas From Lebanon Survives Rare Disease Against All Odds, and Looks for Hope and Solutions From American Doctors
8. Politicians May Not Listen ... But Doctors Do, Says DrScore
9. Annual List of Super Doctors Features 33 Texas Institute for Surgery Physicians
10. More Than Half of Consumers Going to Doctors Less Due to Rising Healthcare Costs, According to checkMD Survey : 38 Percent Lack Adequate Employer Healthcare Coverage
11. Money motivates doctors to reduce ethnic differences in heart disease treatments
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... MD (PRWEB) , ... October 12, 2017 , ... The ... of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual ... – 8. , In honor of Morris F. Collen, a pioneer in the field ...
(Date:10/12/2017)... Maryland (PRWEB) , ... October 12, 2017 , ... ... magnetic drug delivery system that we intend to develop to enable prevention of ... can lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing ...
(Date:10/12/2017)... , ... October 12, 2017 , ... HMP , ... recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ ... on October 11, 2017. , The annual award competition recognizes editorial and design excellence ...
(Date:10/12/2017)... Wesley Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... Chapel is holding a treadmill relay – Miles by Moonlight to raise money for ... by donating $300 or more. , Teams will work together to keep their ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... first interactive health literacy software tool, and the Cancer Patient Education Network (CPEN), ... patient education, today announce a new strategic alliance. , As CPEN’s strategic ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, Inc. ... Day Software and Consulting, LLC , and named its ... Software, based in Tennessee , will ... Day expands EnvoyHealth,s service offerings for health care partners ... "In an interoperable world, ...
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... http://www.rebound-solution.com/ ...
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017  DarioHealth ... and big data solutions, today announced that its MyDario product is expected ... local TV listings for when The Dr. Oz Show airs in your ... The nine-time Emmy ... ...
Breaking Medicine Technology: