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FDA Will Likely Expand Antidepressant Drug Warnings

The Food and Drug Administration (FDA) will likely expand antidepressant drug warnings after members of a U.S. advisory panel agreed with an FDA analysis that found antidepressant use raises the risk of suicidal thoughts and behavior in teens and young adults up to age 24.

FDA Will Likely Expand Antidepressant Drug WarningsThe label changes proposed Wednesday would expand a warning now on the antidepressants that is directed only toward children and adolescents. The changes also would include a recommendation for careful monitoring, especially when patients are beginning treatment. With the advisory panel concurring with the FDA, the changes will likely be approved.

The panel deliberations followed testimony from angry and grieving family members, who pleaded for strong new warnings. Suzanne Gonzalez, shouting and in tears, goaded the panel to action, telling the experts that her 40-year-old husband who had been taking Paxil shot himself.

“I wake up every morning thinking, ‘Oh my God, he’s dead. He is freaking dead.’ Do you wake up and think, ‘How many people are going to die today because I am doing nothing?'” Gonzalez asked.

Some psychiatrists cautioned against tougher language that could scare patients from effective treatment for depression, a mental illness that itself can lead to suicide. Psychiatrists who oppose the warning labels point to a Centers for Disease Control statistic that found that the suicide rate among teenagers rose slightly in 2004 for the first time in a decade, according to the New York Times. And a recent study from the Netherlands found that the suicide rate among children and adolescents there had increased by more than 40 percent since 2003, when antidepressant prescription rates in that country began to drop.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of “Prozac Backlash,” said expanding the warnings wouldn’t scare off patients, but instead would allow them to make informed choices.

A Food and Drug Administration analysis found short-term therapy with the newest antidepressants seemed to increase the chances of suicidal thoughts and actions in adults up to age 25. The drugs appeared to reduce suicidal behavior in older adults, particularly after age 65.

“Our recommendation to the FDA would be that we agree with the conclusions” presented by agency reviewers who evaluated 372 clinical trials involving 11 antidepressants and almost 100,000 patients, said panel chairman Dr. Daniel Pine.

Researchers don’t know exactly why antidepressants may increase suicidal thoughts in young people. However, they do know that the “rollback phenomenon” may contribute to increased suicide attempts. The rollback phenomenon occurs because antidepressants tend to increase patients’ energy levels before improving their moods.

Newer antidepressants include Pfizer’s Zoloft, Eli Lilly’s Prozac, GlaxoSmithKline’s Paxil, Lilly’s Cymbalta, and Wyeth’s Effexor. Sales topped $12.5 billion in 2005, according to data from health information company IMS Health. Some of the drugs, such as Prozac, come in generic versions.

The FDA review found the chances of suicidal thoughts or behavior among adults younger than 25 “approaches that seen in the pediatric population.” In clinical trials of nine antidepressants, 4 percent of patients who took the drugs reported suicidal thoughts or behaviors, compared with 2 percent who were given a placebo.

Overall 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, said Dr. Thomas Laughren, director of the FDA’s division of psychiatry products.

Source: From staff and wire reports

FDA Will Likely Expand Antidepressant Drug Warnings

Rick Nauert PhD

Rick Nauert, PhDDr. Rick Nauert has over 25 years experience in clinical, administrative and academic healthcare. He is currently an associate professor for Rocky Mountain University of Health Professionals doctoral program in health promotion and wellness. Dr. Nauert began his career as a clinical physical therapist and served as a regional manager for a publicly traded multidisciplinary rehabilitation agency for 12 years. He has masters degrees in health-fitness management and healthcare administration and a doctoral degree from The University of Texas at Austin focused on health care informatics, health administration, health education and health policy. His research efforts included the area of telehealth with a specialty in disease management.

APA Reference
Nauert PhD, R. (2018). FDA Will Likely Expand Antidepressant Drug Warnings. Psych Central. Retrieved on March 25, 2019, from
Scientifically Reviewed
Last updated: 8 Aug 2018
Last reviewed: By a member of our scientific advisory board on 8 Aug 2018
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