Federal health officials proposed new label warnings for all antidepressants yesterday, a move aimed at protecting 18- to 24-year-olds who might be at increased risk of suicidal thinking and behavior during early months of treatment.
The “black box” update would follow similar changes made to antidepressants’ labels in 2005 that added a warning of increased suicide risks among children and adolescents but did not give specific ages.
The Food and Drug Administration emphasized that patients who are advised by their doctors to take an antidepressant should not stop using the drug. The proposed warnings, which the agency expects drugmakers to adopt, note that depression and other psychiatric disorders are the major causes of suicide.
“These drugs do have value across the age range, but their use requires certain precautions,” said Dr. Thomas Laughren, director of FDA’s Division of Psychiatry Products.
Dr. Stanley R. Platman, a psychiatrist at Union Memorial Hospital in Baltimore, said doctors discuss the risks with patients, but he said the warning will reinforce the need to see new patients every week or two at the start of treatment. He expects to see a slight drop in young adults agreeing to take the drugs, as was the case after the 2005 warnings that targeted younger patients.
“That may not be such a bad thing, because many drugs are already overused,” Platman said. “It’s always better when the patient knows the pluses and minuses of drugs.”
The FDA can’t order drug companies to change labels. The recommended wording applies to all 36 antidepressants, including Effexor, Wellbutrin and Zoloft. The revised label would also say that adults ages 65 and older taking the medications have a decreased risk of suicide.
The recommendations follow FDA’s review of scientific studies on antidepressant use in more than 77,000 patients. The review found heightened risk of suicidal thoughts and actions among people up to age 24 during early treatment. In December, a panel of FDA advisers endorsed the label changes.
But Dr. David A. Brent, a psychiatry professor at the University of Pittsburgh, expressed concern that the wording of the warnings was so strong it might deter some young adults who need the medicines from taking them.
“That is not the FDA’s intent, but that could be the result. And if it is, we need to reconsider what warning will do the most good and not the most harm,” he said. Brent was co-author of an article, published in the Journal of the American Medical Association last month, that concluded that the benefits to children and teenagers from taking antidepressants outweigh the risks.
In 2003 and 2004, studies examining suicides among teenagers taking antidepressants raised questions about the FDA’s drug safety efforts and prompted the FDA to start seeking label changes.
But the warnings about the use of antidepressants by children and adolescents sparked a backlash among psychiatrists. The American Psychiatric Association said the changes had discouraged use of the drugs and increased the number of suicides.
Dr. Carolyn Robinowitz, a Washington psychiatrist who is the APA’s president-elect, said doctors were already advising potential patients about the benefits and risks of antidepressants. She expressed hope that wording that mentions depression is the major cause of suicide will encourage patients who need the drugs to take them.