FDA Issues Warning on Antidepressants

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March 22, 2004 -- The FDA is issuing a warning about the possibility of worsening depression or suicidal thoughts in people, particularly children, who take any of 10 popular antidepressants, especially at the beginning of treatment or when the doses are increased or decreased. The FDA has sent a letter to drug manufacturers requesting labeling changes on these antidepressants -- warning of possible suicide, worsening depression, anxiety, and panic attacks in adults and children. Antidepressants involved in this warning label request are: Prozac (also sold generically as fluoxetine) Zoloft Paxil Luvox Celexa Lexapro Wellbutrin Effexor Serzone Remeron "We don't know that the drugs are responsible for these behavioral changes, but nonetheless we're telling physicians and families to be aware of this and that if the behaviors do emerge, to get treatment right away," said Russell Katz, a director with the FDA's Center for Drug Evaluation and Research, in a news teleconference today. The proposed warning label will "include information about behavioral changes that may occur in patients who are prescribed antidepressant drugs," said Katz. "This applies to adult and pediatric patients and involves the potential for suicidal thinking or suicidal behaviors and warns the physician and family about any behaviors that might emerge that haven't been experienced before," he added. But the FDA stopped short of recommending people discontinue taking their antidepressants. "We specifically decided not to tell people not to use these drugs," said Katz. "We don't think that is necessary at this point." In addition to looking for signs of worsening depression, the following symptoms may also be a sign of a problem: Anxiety Agitation Panic attacks Insomnia Irritability Hostility Impulsivity Severe restlessness Mania in both adults and children being treated with antidepressants for major depression If these changes appear, treatment should be evaluated, the FDA says. Medications may need to be discontinued when symptoms are severe, begin abruptly, or if they signal a new disorder. There also is concern for people who have bipolar disorder (manic depression) but don't know it. Antidepressants have the potential for provoking a manic episode in these people, the FDA says. Doctors, patients, and family members should be on the lookout for any symptoms of mania, including feeling extremely happy or very irritable, inflated self-esteem, not needing as much sleep as usual, talking, or being more active than usual. Reviewing Studies of Children The FDA has been closely reviewing studies of antidepressants in children for the past year after an initial report on studies of Paxil and other drugs suggested an increased risk of suicidal thoughts in children given antidepressants. No suicides occurred in any of the trials, the FDA reports. The analysis has involved 25 controlled trials with 4,000 children taking antidepressants, said Katz. "Those reviews are ongoing." Today's action "arose from an unexpected observation in some studies of an apparent excess of emotionability, a catch-all term ... that includes suicidal [thoughts]," said Robert Temple, MD, the FDA's director of medical policy. However, closer examination has shown that the accounts are unclear -- whether certain behaviors reported were actual suicide attempts or other self-injurious behavior that was not suicide-related. "As we've gone into the studies in detail, it's become evident that the terms used were highly varied and [the studies] not very well done," Temple said. Experts at Columbia University in New York are providing an independent review of the studies, looking carefully at descriptions of these events to determine whether those cases represent suicidal behavior. "We hope to have a much better idea whether these drugs are effective and whether or not they do cause suicidal symptoms," said Katz. "There is an ongoing awareness that children are particularly vulnerable, that they need additional protection, and that we make sure that all the protections are in place," said Dianne Murphy, MD, the FDA's director of Pediatric Therapeutics. LINK TO STORY

This warning is being a bit over-inflated, I think, perhaps even by the FDA itself. Any decent doctor should keep a very careful watch on depressed patients in the early stages of treatment. Depression is a life-threatening illness - many people with it don't survive, because of suicide. Sometimes all that keeps them from suicide is that they are so depressed that suicide is too hard an effort. When the depression starts to lift because of treatment, sometimes that makes suicide easier. So I think this warning is just telling doctors to keep a careful watch, which they should be doing anyway.

goddam, so glasd i dont take anything like that for my depression. there was something like that in my local paper, but only about prozac. hmmmmmmmm.

I agree that it's very overinflated.

i've cut down my celexa to half my normal dose.and i feel bad.true,not true?dunno?but im stopping this medication.im getting sick of it.i'll just tell my psychiatrist,yeah im feeling great!

Don't lie to your doc, how is that gunna help you? just tell him that it's not working for you.Why did you decide cut your celexa dose? If it's worse now that you've lowered it, maybe you should bring it back to your prescribed dose.

and people told me i should go get some antidepressants for the doctor. Wait in a few years.. more tests and more people using them, they will find out it messes something else up. I don't trust man made stuff.

This risk has really been known for years if you do your research on the medication you would find all the risks and what may be a risk. ITs just now they are acknowling the problem that really was just not mentioned to frequently. Most problems occur when the drug isn't really needed and the doctors persist to prescibe the drug without real reason.

FDA probed on antidepressants, suicide link

Lawmaker says there are 'troubling questions' about review

The Associated Press
Updated: 1:34 p.m. ET April 16, 2004

WASHINGTON - A House committee says it will investigate whether the Food and Drug Administration fully disclosed the disagreement among its scientists about whether antidepressants might be linked to suicide in children

The FDA insists it is not clear whether the drugs have any link to suicidal behavior by children or teenagers, noting that depression itself can lead to suicide. An extensive agency investigation is under way; results are due this summer.

But at a Feb. 2 public meeting, FDA officials announced that some agency scientists believe a link already is proved, and presented the cases of possibly suicidal behavior.

At that meeting, the FDA's scientific advisers concluded that such a link has not be proved. They said that until the issue is settled, parents need to be warned that the drugs may cause agitation, anxiety and hostility among patients unusually vulnerable to rare side effects.

Scientist muzzled?
Critics complain that the FDA scientist who told his bosses he was convinced of a link, Dr. Andrew Mosholder, has been muzzled. Mosholder attended that February meeting but did not discuss his conclusion.

In a letter to Congress that was released Thursday, the FDA offered an explanation: While his boss presented Mosholder's data, top officials did not think Mosholder should argue the case was closed when that was not the agency's position.

"Having Dr. Mosholder present his conclusion to the advisory committee, with the appearance that it was an agency determination ... might lead patients who were actually benefiting from the use of these drugs to inappropriately discontinue therapy," the FDA wrote the House Energy and Commerce Committee.

The agency has urged caution in prescribing adult antidepressants for children. In addition, bowing to pressure from families, the agency warned last month that patients of any age should be monitored closely for signs of suicide when they first start antidepressants or change a dose.

But members of Congress question whether the FDA has gone far enough. Rep. Joe Barton, the House committee chairman, promised further investigation.

"There are troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public," said Barton, R-Texas.

Doctors should use caution
The FDA's drug chief, Dr. Robert Temple, said it is not unusual for agency scientists to disagree. He said the agency's advisers were given a clear picture of that disagreement and the data behind it.

"Nobody should think we're shrinking from this --- we raised it," he said.

"We don't want to scare people off drugs that may very well be useful. We don't want to exonerate drugs if they really are increasing the risk," Temple said. "We thought the investment of a few more months was worth it to get it right."

Last spring, the FDA spotted puzzling side-effect reports in studies of the use of the drug Paxil by children.

The FDA ordered details from the makers of Paxil and other antidepressants, reports that mentioned possibly suicidal behavior. That led the FDA to warn doctors to use caution when prescribing the drugs for minors while the agency assessed the risk.

British health authorities went much further, saying that because only one drug, Prozac, has been proven to alleviate pediatric depression, others are unsuitable for depressed youth.

LINK TO ARTICLE

What's the point? It's rare for anti depressants to cause damage to begin with and anyone taking any kind of medication whether it be for depression or not should be monitored. Everything in this world can have side effects including WEED.

WTF are you attacking me for? I just posted what i read this morning

I'm not attacking you.