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A heated national debate led federal Food and Drug Administration advisers to recommend a strong warning on the labels of antidepressants because of an increased risk of suicide in children.
Now, mental health professionals across the Capital Region are divided over the latest development at the federal regulatory agency, and several local child psychiatrists said they believe it will have a chilling effect. They are concerned it could discourage physicians from prescribing effective drugs because of liability and lawsuit fears.
Yet families struggling to help ease the suffering of their children's depression hope the FDA's stance signals tougher scrutiny of antidepressants and may reduce overprescribing at a time when these drugs generate billions of dollars for pharmaceutical companies.
On Sept. 14, an advisory committee said the FDA should require a black box warning on the label and a medication guide describing possible side effects with each prescription.
The grass-roots drive for stronger FDA warnings grew out of emotional testimony in Washington from families who blamed their children's suicides on drugs they hadn't been told might be dangerous.
"There has been hysteria on this issue, and I'm concerned that people will get the wrong impression that these antidepressants are inherently dangerous and they don't work. That's not true," said Dr. Zvi Klopott, a psychiatrist and medical director for Rensselaer County's mental health program for children and adolescents.
Klopott said he has been prescribing antidepressants for children, some as young as 2, for more than a decade, and there have been no suicides. He considers antidepressants such as Prozac and Zoloft safe and effective as long as there is monitoring and thorough follow-up treatment, particularly in the early stages.
Others praised a tougher FDA stance. "I think stronger warnings are clearly indicated, and a long, hard look at these medications is long overdue at the FDA," said Dr. Steven Sandler, a pediatrician and child psychiatry faculty member at Albany Medical College.
Sandler said the underlying issue is overprescribing and a cozy relationship between pharmaceutical companies and physicians. "I'm not receiving funds from any drug company, but most researchers in this field are," Sandler said.
Drugs that would be affected include Prozac, Zoloft, Remeron, Paxil, Effexor, Celexa Wellbutrin, Luvox and Serzone.
The advisers also urged the federal agency to take the unusual step of making parents sign a form that says they understand the risks before a child receives the first pill.
The FDA is not bound by the recommendations of its scientific advisers, but typically follows them. A final decision is expected in the next few months.
Reversing its previous position that a link could not be established between increased suicide among adolescents and use of antidepressants, the latest FDA analysis showed that two or three out of every 100 youths given an antidepressant displayed increased suicidal thoughts or behavior.
In 2001, 1,611 teenagers nationwide committed suicide. That makes suicide the third-leading cause of death among 15- to 19-year-olds. Furthermore, studies have shown that about one in five teenagers has suffered severe depression by age 18.
The antidepressants covered in the analysis are commonly given to children and teenagers diagnosed with depression. "To just prescribe these antidepressants and send the child back into the same environment is not an appropriate treatment, and yet many doctors are doing just that," said Dr. James Alpert, an Albany-based psychiatrist. His practice has shifted in recent years from a majority of adolescents to almost entirely adults because of insurance reimbursement and managed care rules.
Alpert said the tougher warnings on antidepressants are welcome, but the FDA position is too little, too late. "Without more government funding for mental health treatment, there will not be more monitoring, and nothing is really going to change," he said.
An Orange County woman who now works as a mental health peer advocate at Independent Living Inc. in Middletown personally experienced negative side effects as a teenager.
"A doctor prescribed antidepressants for me when I was 17, and I was never told of what to watch for or what the side effects might be and neither were my parents," said Alexandra Zimmerman, 24.
Zimmerman suffered intense depression, suicidal thoughts and post-traumatic stress disorder after being raped by an acquaintance at 15, an incident she has talked about publicly before. Zimmerman plunged into such despair that she began planning how to end her life. She spent 10 days in a psychiatric hospital and was prescribed Prozac. The drug gave her headaches, made her nauseous and seemed to have little effect on her dark mood. The drug did not make her feel any more suicidal.
"It wasn't like I wanted to go out and slit my wrists after I started Prozac, but I really didn't like it," she said. Zimmerman flushed the pills down the toilet. Her doctor switched her to Paxil.
"I had physical side effects with Paxil, but they weren't as bad and I felt it helped me a little more, but I was still depressed," Zimmerman said. "People should realize that these drugs aren't a cure-all."
Zimmerman took Paxil for 18 months. The drug, together with counseling, allowed her to function well without medication the past six years, she said.
The choice of giving a child antidepressants remains a complex and personal one that has drawn a mixed reaction among members of Families Together in Albany, a nonprofit, parent-run group that provides resources to assist children with psychological problems.
"Many of our families have experienced difficulties with antidepressants in their children and many have experienced positive outcomes," said Paige Macdonald, executive director of the group. More than three-quarters of member families have raised children who have taken the antidepressants flagged by the FDA, she said.
Macdonald's adolescent son has been taking Zoloft for four years to treat Asperger's syndrome, a form of autism, and anxiety associated with it.
"He couldn't function and attend school without that drug," she said. She said there was no increase in suicidal thoughts in her son because of Zoloft. Other parents in her group have reported similar success, without harsh side effects, in treating the child's obsessive-compulsive disorder with those drugs.
The controversy began in England last year, when British health authorities declared antidepressants, with the exception of Prozac, unsuitable for treating depressed children -- but stopped short of an outright ban.
Attempting to strike a balance between no action and an alarmist position has consumed the FDA for the past year. Meanwhile, despite last week's FDA action, the issue remains a volatile one.
"This is a very sad moment for American psychiatry. I'm afraid we're throwing out the baby with the bathwater," said Dr. Joseph Biederman, professor of psychiatry at Harvard Medical School and chief of clinical and research programs in pediatric psychopharmacology at Massachusetts General Hospital in Boston. "All the drugs in question have been a godsend for many of my patients, and now the FDA is striking fear into the hearts of people."
The scientific evidence doesn't support the FDA position, which was a result of political pressure, according to Kara Lee Shirley, assistant professor of neuropsychiatry at The Albany College of Pharmacy. "It was a knee-jerk reaction to appease the politicians and some families who are rightfully angry over the suicides of their children," Shirley said.
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