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New warning labels considered by the FDA
for antidepressants
(June 2004 Issue)

By Ami Albernaz

Antidepressants including Prozac, Paxil and Wellbutrin, might soon come with new warning labels urging users and doctors to watch for agitation, hostility and suicidal tendencies. The Food and Drug Administration is recommending such warnings following the British Government's decision last year not to prescribe antidepressants for children and the subsequent suicides of American teenagers who were using the medications.

While an FDA investigation into a possible link between the drugs and suicidal behavior is expected to end this summer, a renewed discussion of prescribing the drugs has already begun. Elena Eisman, Ed.D., executive director of the Massachusetts Psychological Association says that her organization is taking the opportunity provided by the current scrutiny of antidepressants to spotlight alternatives to medication.

"We're talking about [medications] in terms of current information on risks and benefits, and in terms of alternatives, such as behavioral intervention, where appropriate," she says. To counter what she calls "a rush to prescribe," the association is trying to ensure that other options are presented.

The warning labels, if approved, would be applied to antidepressants in use by adults and children, regardless of whether they are taking the drugs to treat depression or other unrelated problems. Patients taking the drugs - which also include Zoloft, Celexa, Effexor, Lexapro, Luvox, Remeron and Serzone - and experiencing side effects, are advised to contact their physicians, who may prescribe lower dosages or stop the medication altogether.

Although Prozac is the only antidepressant that has been approved to treat depression in children, doctors have been prescribing the others on the grounds that they have been safe and effective for adults.

Some psychiatrists have argued that discouraging the drugs could be detrimental to those who would benefit from them and that the suicides that prompted the scrutiny should not be blamed on the antidepressants, but on the underlying depression. Some psychologists, meanwhile, are advocating that patients proceed with caution.

Nadine Kaslow, Ph.D., president of the American Psychological Association's Society for Clinical Psychology, says that antidepressants often are helpful and advocates "thoughtful choices and close monitoring of the symptoms and the medication," if it is tried.

"Parents and children need to look at the whole picture," she continues. "If depression is mild or moderate, they often do fine with psychosocial therapy. If that's not enough - or if the depression is severe - the data shows that medication can be helpful. The data doesn't say never use medication."

Some practitioners say that the new concern over antidepressants is not much discussed.

"We haven't noticed this research having any impact at all," says Linda Guttman, Psy.D., assistant director of clinical services at the University of New Hampshire's Counseling Center. "My guess is that students are not aware of this particular research. There are always students that have reservations about taking medications in general, however."

Christine Gray, Psy.D., a psychologist in Lewiston, Maine who works mainly with chronic pain patients, also says the issue has not yet "hit the radar" in her state. She does, however, advise her clients to take a realistic approach to psychotropic drugs.

"There's a misunderstanding among some people about what antidepressants will do for them," she says. "There are unrealistic expectations. They're not going to make someone happy, and they're not going to make someone's problems go away."