Healthy Skepticism Library item: 6998

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Carey B.
Study Finds Medication Raises Suicide Risks in Young Adults
The New York Times 2006 Dec 6
http://www.nytimes.com/2006/12/06/health/06drug.html?_r=1&oref=slogin&ref=health&pagewanted=print

Abstract:

In a long-awaited analysis, health officials reported yesterday that antidepressant medications appeared to increase significantly the risk of suicide attempts and related behaviors in adults under 25, while reducing such risks in older people.

The analysis, the most comprehensive and rigorous to date, found that suicidal behavior of any kind was rare, and that people taking the medications were no more likely to kill themselves than those taking placebo pills. But adults under 25 taking the drugs were more than twice as likely as those on placebos to report a suicide attempt, or to prepare for one by, say, writing a suicide note.

The report, which included more than a dozen medications, was compiled by the Food and Drug Administration and posted on its Web site.

The findings are the latest chapter in a yearslong debate that has recently focused on children and adolescents. In 2004, after doing a similar analysis, the F.D.A. required drug makers to include on their labels prominent warnings that the drugs were associated with an increased risk of suicidal thinking and behavior in minors. The new study is likely to shift the same attention to young adults, experts said, and may encourage patient advocates who believe that antidepressants like Prozac have hidden dangers, and psychiatrists who insist that the medications are safe.

Dr. Kelly Posner, an assistant professor of child psychiatry at Columbia, who helped the F.D.A. analyze the data, said the findings should be treated with caution, because the drug trials studied were not designed to evaluate suicide risk.

“We have better, more interpretable data than we’ve ever had before,” Dr. Posner said, “but it’s still not clear that the drugs caused the behavior.”

Dr. Andrew Nierenberg, an associate professor of psychiatry at Harvard Medical School who has consulted with drug makers, said he did not expect the findings to have any immediate effect on practice. “You have to ask the question, ‘What’s the alternative for people who are depressed and in pain?’ ” Dr. Nierenberg said.

He said that he had not seen any elevated suicide risk in young adults in his practice who were on the drugs, and that the drugs more often reduced suicidal thinking in people seeking treatment. “Studies like this one can be informative and make people more sensitive to the drugs’ risks,” he said, “but the thing that’s not emphasized is that the people who are a suicide risk are excluded” from the trials the F.D.A. analyzed.

In the report, F.D.A. scientists looked at antidepressant drug trial data that included nearly 100,000 participants, about half of whom took the drugs. Every major antidepressant maker provided its data to the agency, which included trials for depression, as well as for other disorders, like anxiety and obsessive compulsive disorder.

Comparing side-effect reports from all adults who took the drugs with those who took placebos, the agency found no significant differences in suicidal behavior. But when they broke down the data by age, the agency analysts found that those under 25 were 2.3 times more likely than those on placebos to report having acted on suicidal urges. The risk was the same whether the patients were taking newer drugs, like Prozac from Eli Lilly and Lexapro from Forest Pharmaceuticals, or older products, like imipramine.

The drugs appeared to reduce the risk of suicidal behavior significantly in people 65 and over.

“It is not possible to ascertain factors that would increase the risk of suicidality such as bipolar disorder or other causes of impulsivity that were not diagnosed,” the report concluded. “The lack of a protective effect” in people under 25, it added, “is an opportunity for further research.” A panel of experts is scheduled to meet next week to advise the agency on whether to take action on the report’s findings.