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As FDA Calls for New Warning, Doctors Caution Patients Against Undue Worry

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ATLANTA -- The recent call for a warning on antidepressants sent anxiety through a population that typically doesn't need one more worry -- depressed patients who already may feel hopeless, helpless and stressed.

Now, many doctors who treat them are trying to soothe their fears after the Food and Drug Administration announced eight days ago that it will require 10 medicines used to treat depression to carry a warning of increased risk of suicidal thoughts, hostility and agitation.

Most important, doctors are cautioning patients who take antidepressants to not suddenly stop taking them.

"There's no indication from any of these studies that someone who's been on these for a long time is going to develop these (problems)," said Dr. Shannon Croft, a professor of child psychiatry at Emory University. "There are very few psychiatrists who are worried by this." Some note that the warning was prompted in part by a group of parents of children and teens who had killed themselves while taking the medicines.

"The thing that's so striking about this FDA action is the lack of science behind it," said Dr. Harold Koplewicz, director of the Child Study Center at New York University.

"What stimulated these warnings were passionate testimonies from these parents. While that's not surprising, it does speak to the public pressure the FDA is receiving." The FDA action also comes in the wake of the British government's 2003 advisory that one of the 10 antidepressants not be prescribed for patients younger than 18.

That action was based on a study that showed increased suicidal thoughts among teenagers who took paroxetine, marketed in the United States as Paxil. While no suicides were reported, the paroxetine study caused concern on both sides of the Atlantic.

As a result, the FDA last summer began to review studies of Paxil and other antidepressants used to treat depression in children. Because the studies are conducted and paid for by the drug manufacturers, the FDA found the methodology and reporting to differ widely from study to study, said FDA spokeswoman Susan Cruzan. For example, a panel of the FDA cited the reporting of a student who stabbed himself with a pencil while taking a test as an "accidental injury" rather than an attempt to harm himself.

In February, the FDA agreed to send the data to Columbia University researchers for further review.

Last week's action is an interim warning, Cruzan explained, until a final report is issued this summer. Cruzan said she did not expect the FDA to lift the requirement for a warning, however.

"There are a number of things involved here," Cruzan said. "(but) the concern about monitoring patients using these drugs is triggering this." Psychiatrists said that they have been telling patients of risks for as long as the medicines, called selective serotonin reuptake inhibitors, have been on the market. The SSRIs include Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin.

But Americans have never reconciled their discomfort with the drugs' usage. Discussion over the drugs became especially pitched when news reports revealed that Columbine High School shooter Dylan Klebold was taking Luvox when he committed his killing spree.

It was impossible to say whether the drug caused the tragedy, doctors said, but unease about antidepressants, particularly for children and teens, was heightened.

Psychiatrists stressed then and continue to stress now that the benefits far outweigh the risks. They note also that the suicide rate, particularly among teens, has declined since the drugs were introduced 15 years ago.

But part of the problem in assessing risk is the difficulty in knowing whether the suicidal thoughts and hostility are caused by the depression or the drug used to treat them.

Doctors do know that in most cases negative reactions happen in the first few weeks of treatment.

That makes careful monitoring by trained mental health professionals essential, doctors said. Here are some things doctors watch for: -- Anxiety: "Some antidepressants can increase anxiety," Croft said.

"So if a person is depressed and you add anxiety, that can be bad. But that's something we watch for." -- Bipolar disorder: Sometimes a manic-depressive patient, or someone with bipolar disorder, first comes to a doctor with symptoms of depression and is misdiagnosed. The patient might be given an antidepressant and that could cause an immediate manic, or elated, phase that causes great stress.

-- Increased level of energy before the depression begins to lift: This can happen during the first few weeks of treatment. In such a case, a very depressed person who had been lethargic becomes slightly more energetic and could be at increased risk of doing harm.

The medicines have been prescribed by the millions in the past 15 years, with one of them, Prozac, being approved for use in children and adolescents.

Psychiatrists have been grateful for the treatment tool even while being criticized for writing prescriptions for a pill to improve mood.

While many doctors said the FDA action does not cause them to worry about the safety of the drugs, it could have other consequences.

One concern is that the action could chill what had been a gradually accepting attitude toward mental illness in the United States. That could be particularly bad for children, they said.

"These warnings will increase resistance," said Koplewicz, author of a book on adolescent depression called "More Than Moody." "That's tragic, because the only available, effective treatment for many is medication." Koplewicz said that only one of five children and teens with depression is being treated for it.

Croft sees a possible good that could come from the action. He thinks it may lead to a better understanding of mental illness and help those afflicted with it to know that medicine is not the only cure.

"I think anyone who has depression with significant symptoms enough to warrant being on an antidepressant could benefit from being in therapy," Croft said.

WARNING SIGNS Here are some warning signs for those newly taking antidepressants:

-- Significant anxiety or hostility

-- Thoughts of harming oneself or others

-- New problems with sleeping

WHAT YOU NEED TO KNOW Psychiatrists said consumers should know these things about antidepressants in the wake of the FDA action: -- If you have any questions, see your health care provider immediately.

-- The best person to prescribe antidepressants is a mental health professional -- not an internist, not a pediatrician, not a family practitioner -- who has training in treating depression.

-- The doctor and patient need to look closely in the first few days and weeks after going on an anti-depressant for symptoms of increased anxiety, an infrequent but potentially dangerous side effect of antidepressants.

-- The prescribing doctor needs to closely monitor a person, particularly a child, for the first several weeks, when side effects of anxiety are most likely to appear.

-- The American public should not take this warning as an indictment of antidepressants.

Virginia Anderson writes for The Atlanta Journal-Constitution. E-mail: Editor Notes:Story Filed By Cox Newspapers For Use By Clients of the New York Times News Service

c.2004 Cox News Service


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