Millions of Americans using antidepressants should be watched closely for suicidal tendencies and the popular medications should carry stronger warnings, the government told drug makers Monday.
The Food and Drug Administration’s directive goes further than ever before in cautioning people about antidepressants, which some blame for an increased risk of suicide attempts.
The FDA stressed that such a link has not been proved, and doctors say the medications are helping millions cope with devastating depression. But the agency determined that it makes sense to add the warnings while it continues to examine the issue.
“We think this is good advice, whether the drugs increase the risk or not,” said Dr. Robert Temple, the FDA’s chief of medical policy. “There’s a reason people are put on therapy their depression is worse or somebody’s worried about it.”
Because of that, it’s impossible to say whether some people attempt suicide because of the medication or the underlying depression that caused them to take the drugs in the first place, he said.
“In either case, you really need to pay attention in the early days,” Temple said.
An FDA advisory panel had suggested the change last month after an emotional hearing with testimony from the parents of children and teenagers who attempted suicide or took their own lives after starting antidepressants.
In accepting the recommendation, the FDA is asking for the added warnings on Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro, Luvox, Remeron, Serzone and Wellbutrin. Drug companies do not have to comply with the request but typically follow the FDA’s suggestions, an agency spokeswoman said.
Many of the medications belong to a newer class of antidepressants called SSRIs or selective serotonin reuptake inhibitors credited with successfully treating depression in millions worldwide.
But concerns have been simmering about the use of the medications in young people, especially after a British study last year found a slight increase in suicide attempts among children taking antidepressants versus those taking sugar pills.
In this country, the FDA looked at 25 studies involving 4,000 children, but experts were unable to make a definitive assessment because different researchers used varying definitions for suicidal behavior.
For example, one researcher classified a child hitting herself on the head as a suicide attempt, while another considered it an accident when a child stabbed himself in the neck with a pencil. The FDA has asked a panel of experts to review the data again and reclassify each instance under uniform criteria. The agency hopes the work will be completed by this summer.
In the meantime, the expanded wordings on labels should advise health-care providers to “carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either decreases or increases.”
Some of the symptoms to watch for are anxiety, agitation, panic attacks and insomnia. Doctors who see these behaviors in patients should lower the dosage or stop the medication altogether, the FDA said.
While supportive of the additional labeling, some mental-health professionals said they fear it could scare people away from the medications and from seeking help at all.
“Depression is a deadly illness,” said Cynthia Folcarelli, executive vice president of the National Mental Health Association in Virginia, a consumer-advocacy organization. “We have more suicides in this country every year than homicides, so it really is a serious problem. We want to make sure that a full range of treatment options are available to people.”
The U.S. surgeon general estimates there are 30,000 suicides every year in the United States. According to researchers with Columbia University, 10 percent of all youth suffer from depression, and 1,883 children ages 10 to 19 years old killed themselves in 2001.
Some say one problem is that antidepressant medications increasingly are being prescribed by family physicians, pediatricians and other doctors who are not specialists in mental-health issues. They may not be as familiar with the potential side effects from psychiatric drugs as mental-health professionals.
“Antidepressants are not to be prescribed lightly,” said Dr. Alan Keck, an Altamonte Springs psychologist. “If someone is depressed, they are naturally at higher risk for suicide. So anyone who does this kind of work is going to be looking for these symptoms anyway. That’s common sense.”
“Where you have problems is if someone is just getting medication,” Keck said. “If that’s the extent of the treatment, then you’ve been done a disservice. They should be getting some kind of psychotherapy, too.”
Some psychiatrists also say the drugs are being unfairly connected to suicide attempts because the medications ease the lethargy that often accompanies depression.
After they start taking the drugs, people who were harboring suicide tendencies all along may suddenly find themselves with enough energy to act on them, said Dr. Segundo Imbert, an adult and child psychiatrist with Florida Hospital.
Imbert said he has been prescribing antidepressants for children for about 15 years and thinks the drugs can be beneficial.
Just as with any medication, he said, antidepressants could have side effects, but a conscientious physician will be watching for them.
“I do think they continue to be a safe group of medications,” Imbert said. “The only thing we have to do is be a little more aware of how to use them so as not to harm patients in any way.”