Stronger antidepressant warnings urged

FDA advisory panel wants labels changed to reflect suicide risk to patients ages 18-24

December 14, 2006|By Judith Graham | Judith Graham,CHICAGO TRIBUNE

Young adults are at heightened risk of becoming suicidal when they take antidepressants, and warnings on the drugs' labels should be altered to highlight that potential, a federal advisory committee recommended yesterday.

The committee's action addresses one of the most controversial questions in psychiatry - do antidepressants increase suicidal thoughts and behavior in some patients, and if so, are the risks significant enough to require a regulatory response?

Two years ago, the Food and Drug Administration gave a partial answer when it concluded that antidepressants increased the potential for suicide in children and teenagers and required drug companies to post a strong warning on medication labels.

Yesterday, an FDA advisory committee acknowledged that another group of patients deserves special attention: young adults ages 18 to 24, who also can experience heightened suicidal impulses while taking antidepressants.

Although the risks are small, they should be featured in a prominent "black box" warning on drug labels, the committee recommended in a 6-2 vote.

As for adults 25 years and older, the largest single group of people who use antidepressants, they don't appear to experience elevated levels of suicidal thoughts or actions while taking the medication and no new warnings for older adults are indicated, the committee decided.

If anything, antidepressants appear to protect adults age 30 and over - and especially age 65 and over - from considering suicide, and this should be noted on the drugs' labels, the group said.

Asked why the medications appear to have different effects on people of different ages, Dr. Thomas Laughren, director of the division of psychiatry products at the FDA, said, "We don't know." The finding was part of an extensive new FDA analysis of 372 studies of antidepressants involving almost 100,000 patients.

The report found four extra "suicidal events" in the 18-to 24-year-old age group for every 1,000 patients treated with antidepressants - a slightly lower risk than in children and teens but still significant.

The advisory committee's recommendations disappointed interest groups on every side, including mental health organizations, doctors, lawyers, individuals who say their lives have been transformed by antidepressants and families who claim their loved ones died because of potentially deadly side effects.

"A black box warning will scare people away from treatment and end up causing greater harm than it does good," said David Shern, president of Mental Health America, an advocacy organization.

He noted that fewer than half of people who are depressed receive treatment - whether medication or psychotherapy - and that untreated depression is one of the leading causes of suicide in the United States.

The past two years have demonstrated the "chilling effect" that a black box warning can have, Shern said: During that time, prescriptions for antidepressants for children and teenagers have dropped more than 20 percent, according to some estimates, and suicide rates for teenagers have climbed slightly.

"Black box warnings give the impression to prospective patients that these are dangerous medications that can cause death," when in fact antidepressants help millions of people recover from serious mental illness, said Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Association.

That's the wrong way of looking at the issue, said Kim Witczak, whose husband Tim "Woody" Witczak committed suicide in 2003 a month after being prescribed Zoloft for sleeping problems. He became extremely agitated - a dangerous side effect known as akithasia - and told his wife he couldn't stand the feeling in his head of "being outside my body looking in." She later found him dead, hanged in the garage.

"No one is saying here, `These drugs are too dangerous and we've got to take them off the market,'" she said. "All we're saying is, giving doctors and patients information about what the risks are and let them make an informed decision about what they want to do."

Judith Graham writes for the Chicago Tribune.

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