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FDA Tries to Bridge Data Divide With New Antidepressant Warnings

FDA Tries to Bridge Data Divide With New Antidepressant Warnings

The FDA finds itself straddling a data divide as it decides how to rewrite the black box warnings on the labels of SSRI antidepressants. The agency will almost certainly mandate that the existing black box warning, which addresses suicidality in children and adolescents, be expanded to include young adults up to age 25 or 30. But in what might be a pioneering move for the FDA, the agency will probably also include new verbiage in the warning related to the benefits of antidepressants to people over the age of 30 years, according to Thomas P. Laughren, MD, director, division of psychiatry products at the agency.

Laughren talked with Psychiatric Times a week after the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) recommended changes to the black box warning that was added to antidepressants in January 2005. The PDAC meeting on December 13, 2006, featured 2 internal FDA studies on antidepressants and potential suicidality in the adult population. The studies showed that there was an increased risk among young adults aged 18 to 24 years and a decreased risk for an older group. There were also references to recent publications of data showing suicides in children trending upward and lower suicide rates in areas that had higher
SSRI use.

In the interview, Laughren said, “What we heard from [the] advisory committee concerned the current language in the black box warning having an inhibiting effect on prescriptions of antidepressants, which was never our intent. We will take a careful look at how we can redo the language to give it more balance.”

The American Psychiatric Association (APA) continues to have doubts about the overall benefits of a black box warning for any population group. “While we remain concerned about the impact of any addition to the black box, we applaud the advisory committee's suggestion that, for the first time, the FDA place statements about both risks and benefits within the current black box label,” said Carolyn Robinowitz, MD, president-elect of the APA.

Jason Young, a spokesperson for the APA, added that the group believes that black box warnings should be “scientific,” a standard they currently fail to meet because they neglect to mention data on suicidal thinking in untreated patients. Young suggested that the APA would like to see any expanded black box warning display 2 numeric values next to one another: the chances of suicidal thoughts while taking antidepressants versus the chances among untreated
patients. “That would be very different from the current pediatric label,” he said.

At the end of the December 13 PDAC meeting, the 8 members of the advisory committee who attended the sometimes emotional all-day meeting voted twice. The first time, they agreed unanimously that the FDA should extend application of the current black box warning to a slightly older population, perhaps to age 25 or 30. That was based on the results of the two FDA studies presented and debated during the meeting, which showed the risk of suicidality—not actual suicides—to be 4 to 6 per 1000 patients in the 18 to 24 age group. That compares with a risk of 14 in 1000 patients under the age of 18 who are being treated with antidepressant drugs.

Wayne K. Goodman, MD, professor and chairman of the department of psychiatry, McKnight Brain Institute of the University of Florida, a member of the PDAC and its former chairman, said that “the magnitude of the incremental risk for patients in the 18 to 24 age group is modest.”


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