Study: Suicide Attempts Increased Following FDA Warning on Antidepressants

Suicide-Attempts-Increased-Following-FDA-Warning-on-AntidepressantsA newly released study reveals that suicide attempts associated with antidepressants have increased, while the use of the drugs has dropped.

The study, published in the journal, BMJ, revealed that, following the federal government’s warning 10 years ago, suicide attempts over the following six years revealed a “small but meaningful” increase in individuals ages 10 – 29, according to The Boston Globe. The increase in suicide attempts followed what was described as a “substantial drop” in antidepressant use.

Study authors indicate that patients and doctors became alarmed by news coverage of antidepressant risks, opting against treatment with the drugs that may have prevented attempts at suicide. “Doctors should consider not just the risk of the drug, but the risk of under-treatment,” said lead author Christine Y. Lu, a researcher at Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Health Care Institute, reported The Boston Globe.

Dr. Gregory K. Fritz, a psychiatry professor at Brown University and president-elect of the American Academy of Child and Adolescent Psychiatry, described the research as “well done” and “a major contribution.” He also said that, the study is “showing that what we had feared has actually happened,” according to The Boston Globe. This was the first study to review nationwide suicide attempts over many years and looked at insurance data on 7.5 million people from 2000 to 2010.

In 2004, the FDA mandated a “black box” warning on all antidepressants concerning risks of suicidal ideation. The black box is the agency’s strongest warning. The initial warning stressed risks of suicidal thinking and behavior in children and adolescents taking the medications. In 2007, the warning was expanded to include a recommendation that physicians consider the risk of not prescribing the drugs and asked doctors to monitor patients taking the drugs, wrote The Boston Globe.

“There was a lot of concern that drug companies had manipulated data and underplayed adverse effects,” said Dr. Fritz, who is also academic director of Bradley Hospital, a children’s psychiatric hospital in East Providence, Rhode Island, according to The Boston Globe. “The FDA at that time was not purely doing science. They were responding to a national anxiety. It really points to the fact that you’ve got to be cautious, and there may be unintended consequences.”

Lead study author, Lu, said that the black box is not to blame for prescribing changes, but rather that doctors and patients were affected by news coverage. “It was so intensely and widely publicized, the warning had more impact than it really should have,” she said, The Boston Globe reported. Steven B. Soumerai, study co-author and a Harvard professor of population medicine, said that black box warnings usually do not impact physician behavior, unless accompanied by news reports. “Yes, it starts with the warning,” he said, “but what is really driving the behavior and the fear is more the media.”

Lu does not feel the black box warning should be removed because it alerts people to a potential risks, stresses the importance of monitoring, and emphasizes the dangers of under-treatment. Meanwhile, antidepressant prescriptions are often written by primary care doctors, such as internists, pediatricians, and family doctors, and not psychiatrists, according to The Boston Globe. Dr. Joseph Gold, clinical director of the Child and Adolescent Program at McLean Hospital, a psychiatric hospital in Belmont, said that primary care doctors do not have the specialized training in mental health and tend to stop prescribing when a formal warning from the FDA has been issued.

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