Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients age 24 and younger, according to proposed changes to the drugs’ labels unveiled Wednesday by federal health officials.
However, mental health experts are worried that additional warnings about the risk of suicides linked to antidepressants could curtail their use and ultimately do more harm than good.
The proposed changes would expand a warning now on the labels that applies only to children and adolescents treated with the drugs.
The Food and Drug Administration put forth its plan to update the drug labels early Wednesday at the start of a meeting of outside advisers convened to discuss the proposal. The changes also would include a recommendation that patients of all ages be carefully monitored, especially when beginning antidepressant treatment.
Adding “black box” or other warnings could scare off doctors, parents and patients from the drugs, mental health experts caution. They warn that people with untreated depression — about half of those who suffer from the disease — face an estimated 15 percent greater likelihood of death by suicide.
“My concern is that by not simply promoting good standards of care and by putting on a black-box label, the FDA may unwittingly limit further access to care,” said Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Association.
However, use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company. That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, told panelists.
The Food and Drug Administration recently completed a mass review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released ahead of Wednesday’s scheduled meeting of its psychopharmacologic drugs advisory committee.
The effects of antidepressants on adults from 25 to 64 were mixed, leading the FDA to conclude the drugs had a neutral effect on suicidal behavior for them but possibly lowers the risk of suicidal thoughts. Overall, the risks appear to decline with age and are lessened for seniors, even if the numbers don’t explain why, the FDA said.
The FDA analysis will be incorporated in future changes to antidepressant labels, but the agency wants to first discuss its plans with its outside advisers.
In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.