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:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in agile ... a contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise ... use of Agile methodologies in a consistent and high value manner across CMS ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the loss ... author, William Nowers. Captain Nowers and his wife, Millie, have six children, ten ... the Navy. Following his career as a naval aviator and carrier pilot, he ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)...   Divoti USA will engrave and process ... of the latest FDA requirements, which stipulates new criteria regarding medical ... need of Medical ID jewelry such as Medical ID Bracelets, can ... in terms of the new FDA requirements . ... Divoti offers this dark mark fiber laser ...
(Date:10/11/2017)...  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided ... Piedras, Puerto Rico , where the ... Following a comprehensive onsite ... structural damage, temporary loss of power and minimal water ... manufacturing operations have resumed, and the company expects to ...
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare ... CPR training aide "cprCUBE" on Kickstarter. The device will ... during cardiac arrests with better efficiency compared to the ... offers real-time feedback on efficacy of the compression for ... campaign has a goal to raise $5,000. ...
Breaking Medicine Technology: