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:2/5/2016)... ... February 05, 2016 , ... After years as an active staff surgeon and ... cosmetic surgeon Dr. Wayne Carman transitioned to chief of the Division of Plastic Surgery ... three-year term as chief and began a second three-year term in January of 2016. ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know ... having to wait longer to access the treadmills. It’s a predictable trend. After the ... lose weight and get in shape by joining gyms, starting new walking or running ...
(Date:2/5/2016)... Atlanta, Georgia (PRWEB) , ... February 05, 2016 , ... ... pleased to announce their 2nd Annual No Cost Dental Day to individuals in need. ... 4pm. The purpose of this No Cost Dental Day is to provide dental care ...
(Date:2/5/2016)... ... , ... Health and wellness is a topic that should concern all Americans; ... experiencing an illness. Migraines are a severe form of a headache and often are ... wish the pain on their worst enemy, the feeling can last for many hours ...
(Date:2/5/2016)... CA (PRWEB) , ... February 05, 2016 , ... –This ... on the benefits of having a tankless water heater. To view the report, ... water heaters: tank and tankless. While each has their pros and cons, the type ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... France , Germany , ... Israel ). It includes a 10-year epidemiology forecast for the total ... and sex in these markets. GD epidemiology report is written and developed ... transparent and market-driven, providing expert analysis of disease trends in the 7MM. ... Italy , Spain , UK, and ...
(Date:2/4/2016)... 4, 2016  Edwards Lifesciences Corporation (NYSE: EW ... heart disease and critical care monitoring, announced today that ... agreement with Morgan Stanley & Co. LLC to repurchase ... part of the Company,s previously authorized program to repurchase ... --> --> ...
(Date:2/4/2016)... , Feb. 4, 2016   Bernstein Liebhard LLP ... in the United States District Court for the District of ... (the "Class") consisting of all persons or entities who purchased ... (NASDAQ: INSY ) from March 3, 2015 through January ... certain of its officers with violations of the Securities Exchange ...
Breaking Medicine Technology: