NAMI concerned about FDA "Black Box" warnings

[David Baxter PhD]

NAMI Alert: FDA Requires "Black Box" Warnings and Patient Medication Guide for Antidepressant Medications
October 18, 2004

On October 15, 2004, the Food and Drug Administration (FDA) directed manufacturers of antidepressant medications to revise the labeling on their products to include a "black box" warning that notifies healthcare providers and consumers about an increased risk of suicidal thoughts and behaviors in youth being treated with these medications. The FDA also called for closer monitoring of children and adolescents prescribed these medications.

In addition to the "black box" warning, the FDA’s notice also requires that a patient medication guide be given to patients receiving these medications to advise them of the risks and precautions that can be taken to help minimize those risks. The agency is in the process of developing this guide.

These labeling changes are consistent with recommendations made to the FDA during a recent pediatric drug advisory committee meeting.

NAMI applauds the FDA for calling for close monitoring of youth living with depression and for providing families and young consumers with better information about medications for treating depression in youth. Providing both doctors and families with complete information is part of sound clinical practice. Also essential is the need for open discussion about the benefits and risks in prescribing any medications or other courses of treatment.

At the same time, NAMI is concerned that the "black box" warning may lead to primary care providers refusing to prescribe these medications out of fear of liability. Families are often forced to see a primary care provider because of the severe shortage of child psychiatrists. This could worsen the existing crisis in depression and suicide among youth. Therefore, the "black box" warning must be accompanied by increased training and better education for physicians treating children and adolescents with major depression.

The "black box" warning also fails to acknowledge that untreated depression in youth is directly linked to suicide and that antidepressant medications can be effective in treating many adolescents with depression. If families and providers are not warned about the real risk of untreated depression and suicide, they will be hampered in their ability to accurately understand all of the risks.

NAMI is developing a family guide on treatment options for adolescent depression that will be available in the near future. Families that are concerned about the use of these medications for their loved ones living with depression should talk with their treating provider about the most appropriate course of treatment.

 

[David Baxter PhD]

Antidepressant debate takes a delicate turn Some fear kids could be denied needed care
October 18, 2004

USA TODAY - Tough warning labels for antidepressants ordered by the Food and Drug Administration on Friday could save children's lives, experts say, but others warn that the move could backfire by preventing suicidal kids from getting treatment.

The FDA said antidepressants must carry ''black box'' labels, reserved for the most deadly drugs, warning that the widely used pills increase suicidal behavior in children and teenagers.

Also, medication guides that disclose a drug's proven risks and benefits should be given to everyone picking up antidepressant prescriptions, the agency said.

The actions capped eight months of mounting pressure from Congress and the pleas of dozens of parents who testified at FDA hearings that the pills caused their children's suicides. A scientific advisory panel told the agency last month that it should require the black boxes and medication guides.

About 2 in 100 children taking antidepressants are more likely to think about or try suicide because they're on the pills, FDA scientists say. But there were no suicides reported in their studies.

The black boxes could scare off parents and the doctors of children who need the medicine, says child psychiatrist Harold Koplewicz, director of the New York University Child Study Center.

''Knowing the risks is a good thing, but I worry that some of these seriously ill kids will be denied effective treatment.''

His concern was echoed by the American Psychiatric Association and the National Alliance for the Mentally Ill, an advocacy group.

''There absolutely is a risk'' that kids could go untreated because of the FDA action, says Thomas Insel, director of the National Institute of Mental Health. ''But the public really needs to know the possible dangers. . . . It's not so much the medications we're concerned about; it's how they're used.''

Experts say children with minor or temporary adjustment problems too often are given antidepressants by pediatricians or internists. ''Many will write prescriptions for Prozac like it's penicillin,'' Insel says. More than 1 million children in the USA take the pills.

Black-box labels will prompt greater caution in prescribing, and that's good, says child psychiatrist John March of Duke University. ''For a little while, many doctors will back away from giving these medicines to children. But sick kids will still get treated. Doctors will realize you can't see kids, jam their drug doses way up and not check on them for four to six weeks, which has happened all the time.''

Others applaud the black boxes but say the FDA should have banned use of the pills by kids. ''They took a wonderful first step,'' says Mark Miller of Overland Park, Kan. His 13-year-old son, Matthew, hanged himself in 1997 after a week on antidepressants sparked frenzied, irritable behavior that Miller says was atypical of the boy.

''We know we can't bring Matt back,'' he says. ''But we hope other parents will get the information we didn't, so they can make an informed decision.''