Suicide Risk in Young Adults. Widely used antidepressants double the risk of suicidal behavior in young adults, from around three cases per thousand to seven cases per thousand, according to a federal analysis of hundreds of clinical trials.
It marks the first time regulators have acknowledged that the drugs can trigger suicidal behavior among patients older than 18.
Officials at the Food and Drug Administration said Wednesday that the higher risk was found in patients between 18 and 25 and that the risk faded among older patients. The finding comes two years after the agency ordered a ”black box” warning on the drug labels after the discovery of a heightened risk of suicidal behavior among children taking the pills.
After reviewing the latest data, an expert federal panel on Wednesday recommended that agency officials tell doctors and the public of the risk but also find a way to note that the risk declines with age, and that leaving depression untreated also is risky.
While the studies on the relationship between the drugs and suicide appear contradictory, the experts said one possibility is that the drugs may pose a risk early in treatment but have a protective effect in the long term.
The agency is leaning toward expanding its black box warning
The agency is leaning toward expanding its black box warning, said Thomas Laughren, director of FDA’s division of psychiatric drug products. Officials said they will try to craft language that would urge clinicians to use the drugs carefully, not abandon them.
The new finding created a dilemma for the regulators. Even as it vindicated some of what critics of drugs such as Prozac, Paxil and Zoloft have said for years, the earlier official warnings about the drugs appear to have led to a drop in their use and there are troubling signs that this can lead to an increase in suicides.
After concerns were raised in the Netherlands about the suicide risk, there was a 22 percent drop from 2003 to 2005 in antidepressant prescriptions for patients younger than 18 and a 50 percent increase in suicides, said Robert Gibbons, a professor of psychiatry at the University of Illinois in Chicago. The number of suicides went from 34 to 51.
”What we are seeing is the early signs of an epidemic of suicide in children who are no longer being treated for their depression,” Gibbons said in an interview. U.S. suicide data for 2005 is not yet available, but Gibbons said the FDA’s black box warning had caused a similar decline in prescriptions among children here.
He predicted dozens of additional suicides as a result and warned that any expansion of the black box would have a similar impact on adults.
Robert Temple, director of FDA’s Office of Medical Policy, said regulators were in a bind. On the one hand, they need to tell physicians about the new results in order to warn them to monitor patients closely for suicidal behavior, but if that means doctors stop prescribing the drugs altogether, ”I don’t know what you are supposed to do.”