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FDA regulators are deciding whether to downgrade the risk classification of ECT from high to medium risk. In 1990, FDA regulators proposed declaring ECT devices safe for major depression but because of an uproar by ECT opponents, a final decision was never made.
In the health section of today’s New York Times, Duff Wilson reports that FDA regulators are deciding whether to downgrade the risk classification of ECT from high to medium risk. In 1990, FDA regulators proposed declaring ECT devices safe for major depression but because of an uproar by ECT opponents, a final decision was never made.
The American Psychiatric Association and many leading psychiatrists are recommending that ECT devices be downgraded to the medium risk category. If ECT is to be included in the medium-risk category, ECT devices could be promoted and sold without new testing; if ECT devices retain their high-risk status, costly new studies will be required. Currently, there are only 2 manufacturers of the devices in the United States and neither may be able to afford the new tests and consequently could stop manufacturing the devices.
Depression can be devastating to patients and it is often life threatening. However, controversy about safety and effectiveness remains. Although ECT is well accepted as a treatment for major depression-especially recalcitrant depression-by most psychiatrists, its opponents claim that the adverse effects (eg, memory loss, cognitive deficits) of ECT far outweigh its benefits. Proponents of ECT claim that the adverse effects are temporary and are reversed once treatment has ended, and when ECT works it can be dramatically effective. On the other hand, opponents of ECT claim that the benefits of therapy are only temporary but the memory loss and brain damage is permanent.
According to a February 2, 2011, Medscape report, the FDA has been consulting with its Neurological Devices Panel on the question of whether the regulations on ECT devices should be relaxed. Although they have not been asked for a formal vote on the matter, the panel wants the FDA to keep the Class III classification of ECT devices as high-risk devices.
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