Antidepressants Get FDA Warning

01/17/2008

Agency's Recommendations on Suicide Risk
Include Adults as Well as Children
By ANNA WILDE MATHEWS and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL
March 23, 2004; Page D1

The Food and Drug Administration sharply stepped up warnings about possible risks to patients taking antidepressant drugs, asking doctors, families and caregivers to watch closely for signs of increasing depression or suicidal thinking.

The FDA asked the makers of 10 major antidepressant drugs, including versions of Prozac, Wellbutrin, Paxil, Effexor and Zoloft, to place more detailed, explicit warnings on the labels for their medicines. The FDA didn't order the manufacturers to change their labels, but urged them to do so voluntarily. The new cautions would ask doctors to monitor patients for a variety of symptoms from insomnia and irritability to hostility and panic attacks that might possibly signal greater risks.

The announcement comes more than a month after an FDA advisory committee urged the agency to provide clearer warnings about possible risk of suicidal tendencies in children and adolescents taking antidepressants. Still, yesterday's development went well beyond the earlier recommendations, and included adults as well.

The most immediate result may be that doctors, particularly those who don't focus on pediatric psychiatry, become more cautious in how they prescribe antidepressants for kids and teenagers. They could start prescribing smaller doses and being slower to step up the amounts of medicine.

Doctors may also put greater emphasis on other treatment methods, particularly individual psychotherapy and perhaps family counseling, for young people suffering from depression. "People might wait until they've been in talking therapy a little bit, before trying drugs," said Richard Malone, a child psychiatrist at Drexel University College of Medicine, who was a member of the FDA advisory committee.

The FDA warns:

• Patients on the drugs may have panic attacks, insomnia and hostility

• Patients should be monitored for worsening of depression or risk of suicide, especially at the outset

• When treatment is ending, tapering off slowly may be better than stopping abruptly


The FDA cautioned yesterday that it has not established that the drugs actually contribute to suicidal thoughts or actions, and that it will continue to gather and study data.

It's not clear if all drug companies will adhere to the FDA's new recommendation. A number of manufacturers make drugs on the FDA's list, many of which have generic alternatives. Among them: GlaxoSmithKline PLC, which markets Wellbutrin and Paxil; Pfizer Inc., which sells Zoloft; and makers of Prozac, originally developed by Eli Lilly & Co. and now available generically. Cathryn Clary, a Pfizer vice president for psychiatry and neurology, said the company does "support the FDA's recommendation."

GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company is studying the language of the FDA advisory and hasn't decided whether it will change the labels on its drugs as requested. The instructions for Paxil and Wellbutrin already include precautions that a possible suicide attempt is an inherent risk in cases of major depression.

In addition to making doctors more cautious about prescribing antidepressants for kids and teenagers, the FDA move could lead doctors to gravitate more toward Prozac and its generic versions for young patients. That drug has been approved by the FDA specifically for treating major depression in children and adolescents. (Zoloft and Luvox, meanwhile -- as well as Prozac -- have been approved for obsessive-compulsive disorder in children.)

The FDA also warned parents that they need to play a role in monitoring antidepressant drugs' effects on their children. It can be particularly difficult to understand the effects of psychiatric treatments in children because they may be less able or less inclined to articulate their feelings, doctors said.

At the same time, the FDA and psychiatrists said patients shouldn't stop taking the drugs without consulting their physicians, and parents shouldn't avoid psychiatric help for children who seem troubled. Patients with untreated psychiatric disorders, such as major depression, carry an increased risk of suicide. "I worry that patients, family members or physicians might turn away from antidepressants that might be lifesaving" after hearing this warning, says Eric Hollander, a professor of psychiatry at Mount Sinai School of Medicine, New York.

It's not the first time that the FDA has spoken out on the potential risks of antidepressants. In October, the agency warned doctors to watch for suicidal thinking and suicide attempts among adolescents and children taking a number of antidepressants. That followed similar concerns raised by regulators in Britain.

The FDA advisory committee that examined the issue last month said the data were fragmented and sometimes unclear. The committee saw a "pressing need" for more study. It asked the FDA to warn doctors and the public about the possible risks. Committee members said they were particularly worried about doctors who aren't completely familiar with antidepressants prescribing them to children.

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