U.S. Issues Antidepressant WarningMar 22, 2004 | Los Angeles Times
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The government today told the makers of 10 popular antidepressants to add to their labels the warning that people who take them should be monitored for suicidal behavior.
The Food and Drug Administration warned doctors, patients and their families to closely monitor adults and children taking the medications. And it told them to watch out for other negative behaviors associated with the drugs, including agitation, hostility, severe restlessness, insomnia and mania.
It directed the drug companies to include lengthy warnings on the drug labels of Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron drugs taken by an estimated 20 million people each year.
The warnings came after an FDA advisory panel heard emotional testimony last month from dozens of patients and family members who blame the drugs for suicide attempts, suicides and violent acts. The FDA said it was not clear whether antidepressants contributed to the emergence of suicidal thoughts and behavior, but, at the urging of the advisory panel, the agency decided to issue the warnings before it completed a thorough review of the drugs.
Most of the drugs are known to affect the brain chemical serotonin.
British health authorities sounded the alarm last year, saying long-suppressed research suggests that certain antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Because only one drug, Prozac, has been proven to alleviate pediatric depression, Britain declared others drugs called SSRIs and their close relatives unsuitable for depressed youths.
The FDA issued a caution on pediatric use last year, but today's action goes further.
Among 25 studies of the suspect medications involving 4,000 children and teens, there were no suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, the FDA said.
The studies varied dramatically in what was considered suicidal behavior, making a clear link difficult, FDA scientists have said.
Depression occurs in up to 10% of youths, and 1,883 10- to 19-year-olds killed themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, according to Columbia University scientists who are helping the FDA's probe.
In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants, to treat depression and other conditions, FDA said.