Navigation Links
FDA May Ease Up on Electroshock Devices
Date:1/27/2011

THURSDAY, Jan. 27 (HealthDay News) -- Electroshock devices, currently classified by the U.S. Food and Drug Administration as high risk for the treatment of severe depression, could be downgraded to medium risk this year.

An FDA advisory panel is scheduled to meet Thursday to discuss reclassifying the devices, which would pave the way for wider use among people with depression and other mental illnesses.

A medium-risk classification would put the devices in the same category as syringes and allow them to be sold without new testing, The New York Times reported.

If the current classification continues, the FDA could require manufacturers to demonstrate that the devices are safe and effective, which it has not previously done. Some say the tests that such proof would require would be prohibitively expensive for the device makers.

The American Psychiatric Association supports the classification change, while opponents argue that electroshock therapy can cause long-term brain damage, including memory loss, the newspaper said.

"It's a treatment for the most severe form of depression," Dr. Charles Kellner, chief of geriatric psychiatry at Mount Sinai School of Medicine in New York City, told the Times. "It can really be lifesaving."

Dr. Edmi Y. Cortes, director of psychiatric services at the University of Miami Hospital, said that today's electroconvulsive therapy (ECT) devices are both safe and effective. "It's beneficial that some of the leading experts in psychiatry and ECT are getting together with the FDA to finalize a consensus," she said.

"The devices are effective when used appropriately," Cortes said. "For the most part, they are used to treat severe cases of depression, depression that has not been responsive to medication or depression that presents with symptoms like severe agitation or suicidal thoughts."

This type of depression is fairly uncommon, Cortes said. "For the most part, ETC is used as a second or last resort treatment," she said.

Cortes noted that the treatment can result in some memory loss. "Some people experience spotty memory, some may be transient, some may be longer- lasting. Another common side effect is confusion right after coming out of the anesthetic, which usually resolves before the patient goes home," she said.

The treatment can be given in both in-hospital and as an outpatient therapy, Cortes said. On average, most patients undergo six to 12 sessions, she added.

Some patient's symptoms are completely resolved after treatment. These patients are encouraged to take antidepressants and also to participate in psychotherapy, Cortes added.

"Some don't require ECT again during their life and some require what we call maintenance ECT, which can be done every so often to avoid any recurrence of symptoms," she explained.

How ECT works isn't known. "The most widely accepted theory is that ECT releases large amounts of serotonin in the brain and that's what improves the depressive symptoms," Cortes said. Increasing the amount of serotonin in the brain is how most antidepressant drugs work, she noted.

Electroshock therapy is usually performed under general anesthesia. The procedure lasts about 40 seconds and involves the delivery of a small amount of electric current to the head, which causes seizure activity in the brain. The amount of electricity used has decreased since electroshock therapy was introduced in the 1930s, which has helped reduced the side effects, according to the U.S. National Institutes of Health (NIH).

According to the NIH, electroshock can be helpful for severely depressed patients who don't respond to depression medication or whose depression is accompanied by delusions or other psychotic symptoms. Severely depressed patients who are suicidal or pregnant also may be candidates for electroshock therapy.

Treatments cost $1,000 to $2,500 a session, which includes anesthesiology, Kellner told the Times. Usually six to 12 treatments are needed, the NIH said.

Critics of electroshock therapy, including the New York-based advocacy group Alliance for Human Research Protection, argue that it's unsafe. "It's all trial and error -- it's all experimental," Vera Hassner Sharav, alliance president, told the Times. Sharav questioned why, after years of controversy, there have not been clinical trials.

Prior to Thursday's meeting, the FDA requested information on safety and effectiveness from the two U.S. manufacturers of electroshock devices, Somatics LLC of Lake Bluff, Ill., and the Mecta Corp. of Lake Oswego, Ore.

The FDA doesn't have to follow its advisory committee's recommendation but usually does.

A final decision could come later this year, the Times said.

More information

The American Academy of Family Physicians has more about depression and electroshock therapy.

-- HealthDay staff

SOURCES: Edmi Y. Cortes, M.D., assistant professor, clinical psychiatry, and director, psychiatric services, University of Miami Hospital; U.S. National Institutes of Health; The New York Times


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. SDI Reports: Nearly a Third Of Physicians Use Handheld and Smartphone Devices to Access Medical Information - Physicians Most Likely to be Using Apple iPhone
2. damaka Launches Live Video Streaming on Android and Blackberry Devices
3. Eisner USA, LLC Collaborates with Surgical Review Corp to Provide Innovative Bariatric Devices to Bariatric Surgery Center of Excellence (BSCOE) Participants
4. Rhausler Announces Record Growth of Nearly 700% for its Spinal Implant Devices
5. Damaka Delivers Advanced Sweeping™ Capability of Live Sessions Across Multiple Devices Over WiFi, 3G and 4G Networks
6. FDA Tightens Oversight of Home Medical Devices
7. Data Devices International Secures Exclusive Worldwide Distribution of the Erase-O-Matic Digital Video and Computer Tape Eraser
8. Vital functions monitored with wearable and implantable devices
9. Medical Devices Driving Up Heart Care Costs
10. Intrauterine devices reduce repeat abortions
11. Molecular Devices Relaunches with HiveMind Marketing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... ... 2017 , ... Only two months after the official release of The Private ... (France), XO Private has initiated a second print-run of its lavish luxury travel coffee ... across when open, weighs in at more than six kilos, retails at EUR 1,000 ...
(Date:2/24/2017)... ... ... Dr. Ronald E. Hawkins, vice president for academic affairs ... Bell, DO, MBA, HPF, FACOEP-dist., FACEP, as the new dean of Liberty ... to Liberty from the Ohio University Heritage College of Osteopathic Medicine (OU-HCOM), where ...
(Date:2/24/2017)... ... ... With millions of Americans and people worldwide struggling with ... aware of our options and are empowered with strength and information throughout the ... newest edition of "Vision and Hearing" in USA Today, that will educate readers ...
(Date:2/24/2017)... ... February 24, 2017 , ... With ProGlass Prism users ... X . Users have total control over position, rotation, distortion, edge softness, edge blur, ... Final Cut Pro X. , With ProGlass Prism users are given the tools ...
(Date:2/24/2017)... IL (PRWEB) , ... February 24, 2017 , ... The ... the 7th annual “Imagine Me Beyond What You See” body image mannequin art competition. ... Choice will be showcased and the winner revealed at the 31st annual iaedp Symposium, ...
Breaking Medicine News(10 mins):
(Date:2/27/2017)... Period October – December 2016 Revenues amounted ... -16.4 (-6.4) million Result after tax amounted to SEK -16.3 ... Cash flow from operating activities amounted to SEK -8.3 (-7.3) ... Period full year 2016 ... Operating result amounted to SEK -39.5 (-29.5) million Result ...
(Date:2/24/2017)... YORK , February 24, 2017 Following ... Israel , s AMAR ... $ 250 M w ound care market ... s BST for inclusion in the ... healthcare reimbursement system   E-QURE Corp. (OTCQB: ...
(Date:2/24/2017)... -- Research and Markets has announced the addition of the ... 2025" report to their offering. ... The Global Empty Capsules Market is poised to grow at ... $2.9 billion by 2025. This industry report analyzes the ... well as regional levels presented in the research scope. The study provides ...
Breaking Medicine Technology: