Jan. 28, 2011 -- The recommendations of an FDA advisory panel could mean new restrictions on electroconvulsive therapy -- a controversial treatment used by tens of thousands of U.S. patients with severe depression and other mental disorders.
The experts urged the FDA not to ease restrictions on electroconvulsive therapy (ECT) for many patients. The agency is reviewing the safety of the treatment and could now require companies to prove to the government that their products are safe.
Electroconvulsive therapy involves the delivery of a series of electric shocks through the scalp to the brain. As many as 100,000 patients receive ECT each year in the U.S., mostly for severe depression or other disorders that do not respond to medications.
ECT machines have escaped strict scrutiny by the FDA largely because they were already on the market when the agency tightened rules three decades ago. The treatment is widely viewed as effective for patients who have few other options. But concerns over long-term safety have prompted new attention from regulators.
Of most concern to the FDA is the risk of cognitive side effects, like memory loss, especially after prolonged use of ECT. While most experts agree that the benefits of short-term ECT treatments outweigh the risks for severely depressed patients, few studies look at the effects past six months, experts said.
Members of the advisory panel on Friday urged the FDA not to reclassify ECT machines as generally safe for patients with several disorders, including schizophrenia and schizophrenia-like disorders, bipolar mania, and catatonia -- a mental state in which patients sometimes are in a stupor.
The panel split on whether the agency should ease restrictions on ECT for patients with severe depression. While ECT was viewed as largely effective, experts said they had little information on how to make it safer.
“I think the data is lacking on how we can better mitigate the risks,” said Jane Paulsen, PhD, a neuropsychology researcher at the University of Iowa.
If the FDA keeps its most restrictive “Class III” designation for ECT, companies would have to submit applications showing their machines are safe and effective. Those may be outdated or may not exist at all for many devices, prompting worries that some machines could be forced off the market.
Some experts worried that the need for new data could hinder access to ECT for severely ill patients who get no relief from other treatments.
“There is no alternative to ECT” for many patients with treatment-resistant depression, warned Wayne K. Goodman, MD, a professor of psychiatry at Mt. Sinai School of Medicine in New York. “I think it would be a mistake to even take the risk of leaving it as a Class III [device] and letting it be removed from market."
Advisory panel members also urged the agency to come up with new, plainer warnings for patients and to improve consent forms spelling out the benefits and the risks. That can be a complicated prospect, since mentally ill patients who are candidates for ECT may not be able to fully understand the risks.
Hundreds of patients have complained to the FDA that they were not informed of the potential for memory loss, cognitive impairments, and other problems before they underwent ECT.
“They did not feel that they were adequately informed,” said Malvina Eydelman, director of the FDA’s Division of Ophthalmic, Neurological, and Ear Nose and Throat Devices. “That certainly was an issue.”