Some Experts Blame FDA Labeling for Child Suicide Increase

Feb. 5, 2007 — -- Child and teen suicide rates rose for the first time in more than a decade in 2004 -- and many psychological experts said the stronger warning labels that led to a drop in the number of prescriptions for antidepressant drugs may be to blame.

According to the Center for Disease Control and Prevention's Annual Summary of Vital Statistics released Monday, the suicide rate rose more than 18 percent in those 1 to 19 years old, from 2.2 per 100,000 in 2003 to 2.6 per 100,000 in 2004.

In those 15 to 19 years old, the figures reflected a more than 12 percent rise in suicide, from 7.3 per 100,000 in 2003 to 8.2 per 100,000 in 2004.

The rise occurred at the same time that the Food and Drug Administration mandated heightened warnings on the labels of selective serotonin reuptake inhibitors (SSRIs), a particular class of antidepressant medications that includes Prozac, Paxil and Zoloft.

The "black box" warnings were added in March 2004 over concerns that the medications led an increase in suicidal thinking in patients. The prescribing of these medications to children subsequently dropped by 20 percent.

Not all experts said there was a clear link between the warning labels and the increase in suicide rates, but many believe the association is too dramatic to ignore.

"I have no doubt that there is such a relationship," said Dr. Charles Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory University School of Medicine.

"The concerns about antidepressant use in children and adolescents has paradoxically resulted in a reduction in their use, and this has contributed to increased suicide rates."

"This is very disturbing news," said Dr. David Fassler, clinical professor of psychiatry at the University of Vermont College of Medicine. "The adolescent suicide rate has been declining steadily since the early 1990s.

"The sudden increase in the adolescent suicide rate," Fassler continued, "corresponds to the significant and precipitous decrease in the use of SSRI antidepressants in this age group."

The nonprofit group Mental Health America has also called for a further look into the FDA's decision to strengthen warnings on SSRIs.

"As a result of the agency's activities, dramatic decreases in the use of SSRIs in the adolescent population were noted," said David Shern, president of Mental Health America in a statement issued Monday. "Other research has indicated a general relationship between the use of SSRIs and decreasing suicide rates in the general population.

"We must therefore wonder if the FDA's actions and the subsequent decrease in access to these antidepressants have caused an increase in youth suicide."

Warning Labels May Scare Doctors, Parents

Some doctors say the additional black box warnings may have led medical professionals to be less confident in prescribing antidepressants.

"In the state of Michigan, we have found that our colleagues in pediatrics have become increasingly uncomfortable with the prescription of SSRIs following the institution of the black box warning," said Dr. Sheila Marcus of the section of child and adolescent psychiatry at the University of Michigan Hospitals.

"The past history of such FDA warnings has revealed that they create barriers to care and unnecessarily frighten families away from seeking treatment," Nemeroff said.

Whether SSRIs actually increase the likelihood that a child or teen will commit suicide is still unclear. Studies at the time did show that young patients taking the drugs did have increased thoughts of suicide.

But whether increased thoughts lead to increased action when it comes to suicide is still a matter of debate.

"There could be a small relationship, but we don't have the evidence to support that there is a causal link at this point in time," said Bernadette Melnyk, dean and professor of nursing at the Arizona State University College of Nursing and Healthcare.

"What we know about the link between antidepressants and suicide is they can cause an increase in suicidal thinking, but no study has shown an increase in suicides as a result of antidepressants," said Lori Evans, project coordinator of Treatment of Adolescent Suicide Attempters.

"We do not have the data to know if there has been a significant decrease in the amount of prescriptions given to teens since the warning. Therefore we certainly cannot say there is a causal link."

But Fassler said the new figures suggest that the black box warnings may be doing more harm than good.

"The FDA decision to place a black box warning on these medications remains controversial," Fassler said. "To this day, there are no data demonstrating that SSRI antidepressants increase the actual risk of suicide.

"Conversely, the current data suggest that the decreased use of these medications is, in fact, associated with an increase in actual deaths attributable to suicide."

More Evidence Needed

Despite the suggestions of a connection between the drop in SSRI prescriptions and the spike in child and teen suicides, more research will be needed before a conclusive link can be drawn.

And some say the government has not yet sought an adequate answer to the question of whether this link truly exists.

"I don't think that we know for sure, and that is the fundamental problem here," said Dr. Bennett Leventhal, director of the Center for Child Mental Health and Developmental Neuroscience at the University of Illinois.

"The NIH, CDC and other agencies have failed their responsibility of funding proper studies with enough power to answer the important questions about medical treatment of suicide in children, as well as the side effects of these medications."

Another possibility is that a shortage in child therapists could lead to a decreased ability of children and teens to seek psychological help when it is needed.

"We lack approximately 30,000 child psychiatrists in the U.S., so the gaps in mental health services for those children and youth who need them are huge," said Bernadette Melnyk, dean and professor of nursing at the Arizona State University College of Nursing and Healthcare.

"With one out of four children and teens affected by a mental health problem, less than 25 to 30 percent receive any treatment."

Leventhal said the lack of trained professionals means young patients must sometimes wait a long time for treatment.

"Depression is horrible, but waiting without treatment is worse," he said. "Imagine if we tolerated that for cancer or heart disease."

But the fact that the jump in youth suicide corresponded with the changes in SSRI labeling has many suggesting that the government re-examine its policy toward antidepressant warnings.

"I hope the FDA studies this report carefully," Fassler said. "I think they have an obligation to monitor the impact of their regulatory decisions and to make such modifications as may be appropriate based on subsequent research findings."