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Antidepressant Advisory Raises Questions

Posted - Apr. 16, 2004 at 6:40 a.m.



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Every time Sue Mathews reads or hears reports about a depressed teen who has committed suicide, her heart grieves a little. That child could have been her 15-year-old son, had Mathews not found a way to get him help four years ago.

His saving grace was an antidepressant that belonged to a class of medications called selective serotonin reuptake inhibitors, or SSRIs.

Last month, the Food and Drug Administration cautioned doctors, families and patients about the need to closely monitor children and adults with depression, especially at the beginning of treatment with medication, or when the doses are increased or decreased. The FDA is evaluating studies in children to determine whether SSRIs may elevate the risk of suicidal thoughts and actions.

While Mathews, 50, of Mission Viejo, Calif., agrees that vigilance is paramount, she is concerned that this advisory may intensify the stigma that some depressed teens associate with taking antidepressants. She is worried that parents may reject the option of medication. "The worst thing that a parent can do is to not take the symptoms or behavior seriously, as if it's something their child can control," Mathews said. "But the second worst thing is to acknowledge it, then do nothing."

Some mental-health experts also have reservations about the advisory.

Here, questions and answers about SSRIs and the FDA alert:

Q: What is the purpose of the advisory?

A: It has two recommendations: Adults and children prescribed antidepressants should be closely monitored for worsening depression, suicidal thinking and certain other behaviors when they first take these medications or when the dosage is changed. Manufacturers of 10 antidepressants are being asked to include stronger cautions and warnings about the need to monitor patients for worsening depression and suicidal thoughts.

Q: Which are these antidepressants?

A: Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

Q: What is the advisory based on?

A: The FDA has been reviewing the results of SSRI studies in children since June 2003, after an initial report on studies with paroxetine (Paxil) and subsequent reports on studies of other medications appeared to suggest a greater risk of suicidal thoughts and actions in children taking antidepressants. But on close examination of the initial reports, it was unclear whether certain behaviors reported in these studies represented actual suicide attempts, or other behavior to injure oneself was not suicide-related. The agency is in the midst of reviewing studies on antidepressant use in children.

One of the areas of controversy is the potential for SSRIs to cause side effects such as suicidal thoughts and akathisia, a condition in which one feels restlessness or desire to move, both of which can be risk factors for suicide, said Dr. Gerald Maguire, associate professor of clinical psychiatry at the University of California, Irvine.

Q: Were there suicides in the trials of these SSRIs before they were approved for use?

A: No, there were none.

Q: What are the merits of the advisory?

A: SSRIs are commonly prescribed medicines, so it's a good reminder to physicians about how important it is to accurately diagnose depression and to closely monitor patients, Maguire said.

Q: What are the potential disadvantages of the advisory?

A: Mental-health professionals identified several concerns: "The FDA is misguided here and may stigmatize taking medication further," Maguire said. " SSRIs have provided benefits and will continue to provide benefits for many years to come."

In a statement, Dr. Marcia Goin, president of the American Psychiatric Association, said: "It would be tragic if publicity around the FDA advisory kept people with depression from getting the help they deserve or caused parents to hesitate in seeking needed help for their children. Suicidal thoughts and behaviors are all-too-common symptoms of depression. The biggest threat to a depressed person's well-being is to receive no care at all."

People who are taking SSRI antidepressants might stop taking their medications abruptly, said Darlene Cronin, executive director of NAMI in Orange County, Calif. Serious side effects such as insomnia, agitation, anxiety or relapse of depression could occur.

Q: What should families do if a loved one wants to stop taking an SSRI?

A: Contact the patient's doctor immediately so the physician can evaluate the circumstances. A patient should not stop taking an antidepressant without the guidance and monitoring of his/her doctor.

Q: Where can I get more information?

A: Go to:

Food and Drug Administration: www.fda.gov/cder/drug/antidepressants/default.htm

National Alliance for the Mentally Ill, Orange County: www.nami.org

National Mental Health Association: www.nmha.org/ccd/support/treatment.cfm

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(c) 2004, The Orange County Register (Santa Ana, Calif.). Distributed by Knight Ridder/Tribune News Service.

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