Doctors Urge End of 'Black Box' Warning on Antidepressants

Mental health experts are calling on the Food and Drug Administration to remove its most severe label - the so-called "black box warning" -- on all categories of antidepressants because it has been "highly correlated" with a more than 33 percent jump in suicide attempts over the last decade as doctors and patients who could benefit from the drugs have shied away from using them.

A June study published in the BMJ backs up previous research that shows a link between fears about the use of antidepressants and young people taking their lives.

The data is "startling," said Dr. Gene Beresin, executive director of The Clay Center for Young Healthy Minds, which is affiliated with Massachusetts General Hospital.

"A black box warning means parents and doctors must be aware and monitor," he told ABC News. "But that's the next closest thing to prohibition."

"If an infection, asthma, or heart condition increased 30 percent over the last decade, the public would go ballistic," said Beresin. "The FDA would have been under massive attack from all sectors of the population if any other medical condition escalated in this manner. ... Everyone would be scrambling to reduce any and all possible risk factors."

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In 2003, the FDA reviewed clinical trial data on 2,200 children who had been treated with SSRIs, selective serotonin reuptake inhibitors, a widely prescribed class of antidepressants. It noted a 4 percent increase in "suicide thinking and behavior" among those aged 18 to 24 during the first two months of treatment.

In October 2004, the FDA issued its most serious warning on all categories of antidepressants, indicating a suicide risk in children and adolescents with major depressive disorders. In 2006, the warning was extended to young adults up to 25 and recommended that doctors "must balance this risk with the clinical need."

But the FDA study was limited in scope, according to psychiatrist Beresin. One of the side effects of SSRIs is "a certain amount of agitated behavior, but there were no attempted suicides and no deaths."

"Teens may be suicidal anyway -- that was worrisome," he said. "But nobody died and nobody killed themselves."

Beresin and other mental health professionals have argued that the perceived risks of antidepressants elicited fear among parents and general practitioners, the doctors who typically first diagnose mental disorders. And they say many young people who could have benefited from the drugs went untreated.

Suicide rates have been rising steadily for five years, according to The American Foundation for the Prevention of Suicide. Rates among those 15-24 increased from 10.5 deaths per 100,000 in 2010, to 10.9 in 2011.

The foundation has opposed the FDA warning, urging a "more balanced approach" to the labeling. "The warning was very extreme given the data they were analyzing at the time," said its chief medical officer, Dr. Christine Moutier. "We have major problems with the way the FDA interpreted the data."

"The sad thing about the black box warning has been the tremendous effort made in the last 15 to 20 years," Moutier said of studies that showed a relationship between depression and elevated risk of heart attacks. "It was one of the pivotal findings on many impacts on the body. It started to validate it as a psychological illness and not just what happens when a person is thrown into stress."

She said the study results showing a new increase in suicides as a result of FDA warnings are "a step backwards in terms of treatment of this common health condition."

But the FDA stands firm on what it officially calls its "box warning." Agency spokeswoman Sandy Walsh said the label is "an important risk signal.

"The labels also say that 'suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide,'" she wrote ABC News in an email. "It should be emphasized that the warnings on the drugs do not say not to treat depression, they say suicidality is a risk in young people, and so the clinician should monitor the young patient when starting, or increasing the dose, of these drugs."

"The warnings do not suggest avoiding the drugs," said Walsh. "The FDA has not tried to discourage use of antidepressant drugs in people who may benefit from them. And, the current labeling and patient medication guides remind physicians and caregivers of the monitoring that is needed for patients taking these medications. The FDA has tried to balance the suicidality warning language with a reminder that depression is a serious illness that itself is the major risk factor for suicidal thoughts and actions.

"At this time nothing indicates a need for change in the boxed warning on these drugs, which urges attention to patients starting treatment, which the FDA feels is still good advice."

The latest BMJ study was carried out by Harvard University's Department of Population and Medicine and funded by the National Institute of Mental Health. It analyzed data on more than 7 million patients in the U.S. Mental Health research network between 2000 and 2010.

It noted a 24 percent decrease in antidepressant prescriptions among young adults and a 33.7 percent increase in suicide attempts by drug overdose alone in the two years following the black box warning.

The study showed no jump in such attempts among adults older than 29. Completed suicides did not change for any group, although researchers said the chance of completing suicide by overdose is rare, so this was an expected result.

A 2007 study published in the American Psychiatry Journal of Psychiatry backs up the most recent research. It examined prescriptions of SSRIs from 2003 to 2005 in patients up to the age of 19 in both the United States and The Netherlands, right after the FDA warning. It noted a 22 percent drop in prescriptions and a 14 percent rise in actual completed suicides, not just attempts.

In The Netherlands, the drop in prescriptions was similar, but the rise is suicide rates was 49 percent. Both countries showed only an increase in suicides among young people, not adults. Researchers said they believed the warning was premature.

The National Institute of Mental Health states that the benefits of antidepressants "likely outweigh their risks to children and adolescents with major depression and anxiety disorders."

Psychiatrist Beresin adds that antidepressants are "very safe, the SSRIs in particular."

Other medications including steroids, cholesterol drugs and antibiotics can sometimes be "extremely dangerous" on the body's organs, but carry no black box warning, he said.

"Depression is one of the most debilitating illnesses known to mankind with one of the highest death rates," said Beresin, who blames lack of education for fear of antidepressants. He argues that not all patients with mental disorders require medication, and many do well on psychotherapy alone or in conjunction with drugs.

"Yes, you have to monitor their use and be vigilant," he said. "But we need to drop the warning and use antidepressants as part of a comprehensive treatment plan."

Beresin said he sees stigma as a "huge" part of the problem.

"The entire culture has a prejudice against patients with psychiatric disorders and it's prevalent not only among the general population but common in medical schools and among physicians," he said. "People don't understand psychiatric illnesses and see it as a moral or ethical problem. ... They deny it exists."

Dr. Suneel Kamath and Dr. Natasha Demehri of ABC's medical unit contributed to this report.