FDA Says Antidepressant Patients Need Watching

Mon Mar 22, 6:27 PM ET

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By Susan Heavey

WASHINGTON (Reuters) - Patients taking anti-depressants, including children and teenagers, should be closely monitored for signs of worsening depression and suicidal thoughts, U.S. health authorities said on Monday.

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The warning comes after a panel of experts last month called on the U.S. Food and Drug Administration (news - web sites) to issue stronger warnings about the possible risks of suicidal behavior among children and teenagers taking antidepressant drugs.

U.S. health officials are studying whether antidepressants can make children and teenagers suicide-prone, but have not yet reached a conclusion.

"We do not know whether or not the treatment ... causes these changes. It may just be the natural course of the disease," said Dr. Russell Katz, head of neuropharmacological drugs at the FDA's Center for Drug Evaluation and Research.

Until it concludes its studies, the agency called on doctors to closely monitor for signs of hostility, anxiety, insomnia, and other behaviors that could signal worsening depression and suicidal thoughts.

Regulators first alerted physicians to carefully watch children or teenagers taking antidepressants last fall. Today's stronger warning calls for closer monitoring and urges patients, families and caregivers to spot behavioral changes.

Patients should alert their doctors, who may consider lowering the dose or ending use of the drug, the FDA said.

The agency also asked manufacturers to change the labels of 10 drugs to include larger and more prominent warnings about patient monitoring.

Those 10 drugs include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft, and three GlaxoSmithKline Plc drugs -- Wellbutrin, Zyban and Paxil.

The FDA is also evaluating Forest Laboratories Inc.'s Celexa, Wyeth's Effexor, Bristol-Myers Squibb's Serzone, Solvay's Luvox, and Akzo Nobel's Remeron.

Questions about a possible link with suicidal behavior arose last year when regulators were reviewing clinical trials of children who took Paxil.

Only Prozac, sold generically as fluoxetine, is approved for treating pediatric depression. Eli Lilly said it welcomed monitoring but emphasized the FDA has not yet found a clear link between antidepressants and suicide.

"Since suicidal thinking is an inherent part of depression, we believe careful monitoring of patients is very important and worthwhile," Eli Lilly spokesperson Jennifer Yoder.

The impact of the FDA warning on drug stocks was unclear. The American Stock Exchange pharmaceutical index closed down 0.89 percent on Monday, a day when major indexes fell more than 1 percent on global security fears.

In Britain, health authorities have advised doctors not to prescribe most SSRI drugs, or selective serotonin reuptake inhibitors, to anyone under 18.

Dr. Richard Gorman, of the American Academy of Pediatrics, said it was too soon to tell whether British officials were being overly cautious or whether U.S. regulators "dragged their feet."

Either way, antidepressant use in youth "should have been studied prior to being released," said Gorman, a pediatrician in Baltimore.

Experts on last month's panel were especially concerned with suicide risk in youth, but the FDA said it was also reevaluating the risk for adults, who should also be monitored.

FDA officials said they plan to make their final decision in September. (Additional reporting by Lisa Richwine)

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