FDA Orders Strong Antidepressant Warnings

[MrRant 0]

By DIEDTRA HENDERSON, AP Science Writer

 

WASHINGTON - The Food and Drug Administration (news - web sites) on Friday ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them. 

 

Patients and their parents will be given medication guides that include the warning with each new prescription or refill.

 

Dr. Lester Crawford, acting FDA (news - web sites) commissioner, said the agency based its decision on the "latest and best science."

 

"We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately," he told reporters.

 

"Antidepressants increase the risk of suicidal thinking and behavior ... in children and adolescents with major depressive disorder and other psychiatric disorders," the warning begins. Those risks must be balanced against clinical need, the label indicates in a warning surrounded by a black box, hence the "black box" designation.

 

The information guide, available within weeks for patients and their parents, echoes those warnings.

 

The FDA's action, which follows to the letter a recommendation of its advisers, was driven by data that showed that on average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts and actions. Independent experts, working with Columbia University, based the finding on a review of data from 24 trials that involved more than 4,400 patients taking antidepressants. They found a greater risk during the first few months of treatment.

 

Crawford said suicides among youths decreased by 25 percent in the last decade, as antidepressant prescriptions to children soared. Children aged 1 to 17 now account for 7 percent of all antidepressant prescriptions.

 

Researchers say that although antidepressants were found to slightly increase the risk of suicidal thoughts and behavior in children, the drugs appear to have an even more powerful affect in preventing actual suicide.

 

The American Psychiatric Association expressed concern that the agency's actions may lead to fewer antidepressant prescriptions for patients most in need. "This would put seriously ill patients at grave risk," the association said in a statement.

 

Eli Lilly and Co., which manufactures Prozac, the only antidepressant found to be safe and effective for children, echoed the APA's concerns.

 

"Lilly supports the recent FDA efforts," the company said. However, a "black box warning on antidepressants may have a dangerous effect on appropriate prescribing for patients who urgently need proven treatment options."

 

The FDA said that concern was raised during advisory committee meetings and in its internal discussions. Still, the black box is the best way to ensure patients and doctors discuss the risks and benefits of the drugs.

 

"We felt that it's one of the most important tools we have to get the message out to people that these drugs shouldn't be used casually," said Dr. Sandra Kweder, acting director of the FDA's Office of New Drugs.

 

Other drug manufacturers endorsed the FDA's action.

 

"We agree with the FDA that providing additional information to everyone — from health care professionals to parents and patients — is one of the most positive steps that can be taken to advance the diagnoses and treatment of adolescents with depression," said Mary Anne Rhyne, a GlaxoSmithKline spokeswoman.

 

Glaxo, the maker of Paxil, settled a lawsuit filed by New York's attorney general by releasing summaries of all its clinical trials. The lawsuit accused the company of not disclosing fully negative information about Paxil's safety record.

 

 

 

The FDA said parents and physicians will be advised to look for warning signs in children that include worsening depression, agitation, irritability and unusual changes in behavior. Those worrisome signs could come within the first months of starting an antidepressant or if the drug's dosage is changed, higher or lower.

 

Doctors and families are asked to have at least weekly, face-to-face contact with a child taking an antidepressant during the first four weeks of treatment. Biweekly visits would occur for eight more weeks and, as needed, after week 12.

 

The warning notice says caregivers and physicians should be equally as vigilant with adults who take antidepressants.

 

Kathleen Bodnar, a grieving mother, expressed the fear that the warning information will go to people receiving the drug but not necessarily to families or others who might best monitor behavior.

 

"If my daughter were living with me, I could be watching her every single day and notice the difference," said Bodnar, whose 21-year-old daughter, Liz Torlakson, killed herself two days after restarting an antidepressant that had been stopped because she had the flu. "If the doctor waits, even once a week, it's not going to be often enough."

 

Because the FDA chose its most strident alert, the warning must be included in advertising. That means a trend that startled federal advisers — free samples of antidepressants given to treat other medical conditions — also must carry warnings.

 

"These medications were being used outside their indications by physicians who sometimes distributed samples to the families," said Dr. Laurence Greenhill, a pediatric psychiatrist in New York. "In this case, advertising sampling always will have the black box warning on it."

 

The new warnings will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.

[teke184 0]

This falls into the category of "Duh", IMHO.

 

 

If you need to be on anti-depressants, chances are that you COULD entertain those thoughts anyway.

 

On top of that, these drugs have a "loading" phase in which a person's chemistry is unbalanced. At that time, there's an increased chance of unusual behavior. That's why a person taking the medication for the first time is supposed to be under medical supervision for the first few weeks they're on the medication.

 

 

 

If you want a drug that causes suicidal tendencies without being associated with anxiety or depression, try Accutane. It's for acne problems but can cause birth defects if taken while pregnant AND increases the risk of suicide. (A friend of mine was on this and attempted suicide. Thankfully, he pulled through and has no long-term ill effects from it)

[2GOLD 0]

So, people who take Anti-depressants may be depressed enough to take their own lives?

 

Get outta here!

[Guest MikeSC]

So, people who take Anti-depressants may be depressed enough to take their own lives?

 

Get outta here!

Do you doubt that a lawyer WOULDN'T sue because of a death "caused" by this?

-=Mike

[2GOLD 0]

So, people who take Anti-depressants may be depressed enough to take their own lives?

 

Get outta here!

Do you doubt that a lawyer WOULDN'T sue because of a death "caused" by this?

-=Mike

 

Considering we live in a country where someone needs to be told on McDonald's coffee that it MIGHT be hot?

 

No, of course I'm not surprised.

 

Frivilous lawsuits? F*CK YEAH!

[Guest whitemilesdavis]

However, if the suicide rate were higher for those patients on the drug, rather than those on another drug, don't you think that's something worth looking into?

[teke184 0]

However, if the suicide rate were higher for those patients on the drug, rather than those on another drug, don't you think that's something worth looking into?

Yes, it's worth looking into but, and that's a BIG "but", these people obviously had some emotional issues before. That's why they were on an ANTI-DEPRESSANT.

 

 

 

It's worth checking up on so that doctors can prescribe these properly, NOT so a shyster like an F. Lee Bailey or Johnny Cochrane can sue pharmaceutical companies and get millions out of them.

 

Proper prescription and use by a doctor should be a big issue considering that, for whatever reason, there's a big movement to overmedicate kids these days. There ARE legitimate uses of this kind of medication but there's probably a LOT of doctors who just prescribe these without considering the possible effects.

 

(The doctors' choices in anti-depressants being so wide is a large problem because it may take several tries before they find a drug that works properly for the kid. They may start off on Paxil, move to Zoloff, then Effexor, before finally ending up on Prozac. While these are very similar because they're all seratonin-regulating drugs, there are enough differences between them that people will have widely varying side effects)

[Guest MikeSC]

However, if the suicide rate were higher for those patients on the drug, rather than those on another drug, don't you think that's something worth looking into?

Yes, it's worth looking into but, and that's a BIG "but", these people obviously had some emotional issues before. That's why they were on an ANTI-DEPRESSANT.

 

 

It's worth checking up on so that doctors can prescribe these properly, NOT so a shyster like an F. Lee Bailey or Johnny Cochrane can sue pharmaceutical companies and get millions out of them.

How would you prove that an anti-depressant doesn't work? As you said, if they're taking them --- suicide is ALREADY a problem.

-=Mike

[teke184 0]

However, if the suicide rate were higher for those patients on the drug, rather than those on another drug, don't you think that's something worth looking into?

Yes, it's worth looking into but, and that's a BIG "but", these people obviously had some emotional issues before. That's why they were on an ANTI-DEPRESSANT.

 

 

It's worth checking up on so that doctors can prescribe these properly, NOT so a shyster like an F. Lee Bailey or Johnny Cochrane can sue pharmaceutical companies and get millions out of them.

How would you prove that an anti-depressant doesn't work? As you said, if they're taking them --- suicide is ALREADY a problem.

-=Mike

Let's just say I know a bit about these and that the prescription of these drugs is more of an art than a science.

 

The effects vary enough from person to person that a doctor needs to be VERY careful in prescribing these kinds of drugs.

[Guest MikeSC]

Let's just say I know a bit about these and that the prescription of these drugs is more of an art than a science.

 

The effects vary enough from person to person that a doctor needs to be VERY careful in prescribing these kinds of drugs.

I'd imagine any drug that impacts the chemistry of the brain is something one should not screw around with.

-=Mike

[Guest whitemilesdavis]

(The doctors' choices in anti-depressants being so wide is a large problem because it may take several tries before they find a drug that works properly for the kid. They may start off on Paxil, move to Zoloff, then Effexor, before finally ending up on Prozac. While these are very similar because they're all seratonin-regulating drugs, there are enough differences between them that people will have widely varying side effects)

 

This is a very accurate statement, and the one reason that I believe the doctors must be held accountable. Most doctors will prescribe an anti-depressant (non MAOI) within 5 miutes of first meeting the patient. Like you said, it's kind of just a hit or miss, and unfortunately the miss appears to carry mammoth consequences.

 

It is also incorrect to assume that all people taking anti-depressants have at any point been suicidal. They are often prescribed for things like general anxiety disorder and obsessive compulsive disorder. That would be another study I'd like to see; how many of these people hadn't been suicidal before the meds.

[Guest Agent of Oblivion]

I've been perscribed Trazodone for my horrible insomnia, even. It's an older SSRI, but it doesn't make me want to off myself any more than daily life normally does.