Showing posts with label FDA advisory committee. Show all posts
Showing posts with label FDA advisory committee. Show all posts

Tuesday, June 2, 2009

Depression Treatment Wanes Following FDA Warnings

Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.

Researchers at the University of Colorado say the U.S. Food and Drug Administration's advisories about the use of selective serotonin reuptake inhibitors (SSRIs) appear to be associated with "unintended" and "persistent" changes in the diagnosis and treatment of depression, especially in children and teens. They also observed a "spillover effect" on adult depression care.

"We don't know why; we just do know after the warnings these things did change, so it had an effect on treatment patterns for depression," said study co-author Robert J. Valuck, a professor of clinical pharmacy at the University of Colorado Denver's School of Pharmacy.

The report appears in the June issue of the Archives of General Psychiatry.

From the time the FDA issued its warning in 2003 through June 2007, primary-care physicians wrote 44 percent fewer SSRI prescriptions for pediatric patients than historical trends predicted, and 37 percent fewer for young adults. Yet there was no change in alternative medications or psychotherapy to compensate for the decline in SSRI prescriptions for these patients.

"It does look concerning, that the patients are not getting treated," said John F. Curry, director of clinical psychology training at Duke University Medical Center in Durham, N.C.

In October 2003, the FDA warned about the increased risk to children and teens of taking SSRIs, citing an increased risk of attempted suicide and suicidal behavior. A little over a year later, the agency directed pharmaceutical manufacturers to add a "black box" warning to medication labels, urging close monitoring of patients taking these drugs.

RERAD MORE @ ATLANTA JOURNAL CONSTITUTION

Sunday, November 23, 2008

FDA Panel Slams Rising Antipsychotic Use In Kids

After a steady stream of reports that antipsychotics are increasingly prescribed to children, often for unapproved uses, such as treating attention deficit disorders (back story), an FDA advisory committee yesterday chastised the FDA for not doing more to discourage such prescribing.

For instance, more than 389,000 youngsters last year were given Johnson & Johnson’s Risperdal, and 240,000 were 12 or younger, The New York Times writes. Often, the drug was prescribed to treat attention deficit disorders, but Risperdal is not approved for that use and its risks - weight gain, metabolic disorders and possibly permanent muscular tics - aren’t justified, panel members said.

“This committee is frustrated,” Leon Dure, a pediatric neurologist from the University of Alabama School of Medicine and panel member, told the meeting. “And we need to find a way to accommodate this concern of ours.”

However, Tom Laughren, director of the FDA’s division of psychiatry products, told the panel that the agency could do little to fix the problem and, instead, pointed the finger at medical specialty societies, which he insisted must do a better job educating doctors about side effects.

READ MORE @ PHARMALOT