one in the eye for Pam Armstrong @ C.I.T.A !!!!Tricyclics to get suicide warning

[Guest guest]

" The advisory committee decided that the suicide warning should also

be placed on the physician prescribing sheets for an older set of

antidepressants called tricyclics. These medicines have largely

fallen out of favor because of the damage they can do to patients'

hearts and the risks that result from overdoses.

The warning was extended to them in part because of the " great risk

in scaring clinicians back to the tricyclics, " said Dr.

Laughren, a top agency official. ......... "

from the NewYork Times

Doctors Say They Will Cut Antidepressant Use

New York Times

Psychiatrists, pediatricians and family practice doctors said in

interviews that they would restrict their use of antidepressants in

the wake of a federal advisory committee's decision that the

medicines should contain severe warnings about the risks of suicide.

Dr. Lerman, a child and adolescent psychiatrist in New

York City, said that he would no longer prescribe the medicines to

some children and that for the rest he would sit down with their

parents and discuss in detail the risks of the drugs.

The advisory committee made its recommendation after reviewing

numerous studies of antidepressants. Although no children in any

study of the drugs committed suicide, there were reports of

increased suicidal thoughts and behavior. The risks are greatest in

the first weeks of therapy.

" Some parents are very uncomfortable with their kids being on

medication to begin with, " Dr. Lerman said, " and this will be enough

so that some parents will not allow their kids to be on medicines. "

Meanwhile, top officials at the Food and Drug Administration have

decided to re-evaluate whether the drugs can cause adults to become

suicidal, too. Dr. Janet Woodcock, the agency's deputy commissioner

of operations, said in an interview that for years the F.D.A. had

largely evaluated the risk of suicide in adults by analyzing the

final outcomes of antidepressant trials. That analysis has shown no

link to suicide or suicidal behavior, she said.

But the agency identified the risk of suicidal thoughts and behavior

in the trials involving teenagers and children by analyzing in a new

way the adverse-event information provided with the trials. The

agency is now gearing up to do the same thing in its adult trials, a

database that includes 234 tests with more than 40,000 patients.

" I think there might be more to be learned, based on what we learned

from the pediatric studies, " Ms. Woodcock said.

In the meantime, doctors will have to struggle with how to treat

depressed children and teenagers. There are few good options. While

data from 24 studies of nine drugs provided wildly different

estimates of each drug's benefits and risks, the advisory committee

decided that the studies were so small that there was no convincing

evidence that any drug was safer than another. And studies that

included one-on-one talk-therapy failed to show any benefit for that

treatment.

The advisory committee decided that the suicide warning should also

be placed on the physician prescribing sheets for an older set of

antidepressants called tricyclics. These medicines have largely

fallen out of favor because of the damage they can do to patients'

hearts and the risks that result from overdoses.

The warning was extended to them in part because of the " great risk

in scaring clinicians back to the tricyclics, " said Dr.

Laughren, a top agency official.

Indeed, committee members openly worried throughout their

deliberations that their decision might lead some physicians to stop

treating depression in children and teenagers. In interviews, some

clinicians said the committee's push for a warning had done just

that.

" I can tell you that my writing for antidepressants for kids has

dropped off dramatically, " said Dr. Kennedy, a family

practice physician in Augusta, Ga.

" It used to be that when I saw a kid who was 14, 15 or 16 and who

was really down, I felt very comfortable writing them an S.S.R.I.

prescription, " Dr. Kennedy said, referring to a class of

antidepressants. " I don't now. "

Whether antidepressant prescriptions for children and teenagers will

really decline is unclear. In March, the F.D.A. issued a vaguely

worded warning about suicide risk, and it had no impact on

prescriptions trends, agency officials said. Nearly 11 million

prescriptions for antidepressants were given to children and

teenagers in 2002, and that total has since been growing steadily.

In

the first six months of this year, the number of such prescriptions

grew almost 8 percent.

Indeed, worldwide sales of antidepressants in the 12-month period

ending in March were $19.97 billion, according to IMS Health, a

pharmaceutical information and consulting company, making them among

the biggest selling drugs.

Most physicians have written scores of prescriptions for the pills

with no ill effects. And since doctors are unable to distinguish

between a drug and a placebo effect, many feel the drugs work quite

well. In fact, the drugs have by and large not proven any more

effective in children and teens than placebos, and even in adults

prove better than placebos in only half of all studies.

Still, the warning that the advisory committee is recommending, a so-

called black-box warning on the label that explicitly talks of the

suicide risk, is a serious precautionary measure, and physicians

said in interviews that the promise of such a warning has gotten

their

attention. The risk of suicide from the drugs is small. If 100

children and teenagers are given the drugs, two or three will become

suicidal who would not have been suicidal if given placebos.

Dr. Albert Melaragno, a pediatrician in Valencia Calif., said that

five years ago he never prescribed antidepressants. But, Dr.

Melaragno said, the scarcity of psychiatrists and the growing

unwillingness of managed-care plans to pay for mental-health

services has thrust the task of dealing with depressed children and

teenagers

onto him.

The new warning will lead him to be more cautious in using the pills

and more likely to refer patients to psychiatrists, he said. But he

feared that many patients who need the medicines will now refuse

therapy.

" It's raised such a specter with patients that more of the teens who

have the need for treatment will be frightened off of using it and

suffer more because of that, " Dr. Melaragno said.

[Guest guest]

" The advisory committee decided that the suicide warning should also

be placed on the physician prescribing sheets for an older set of

antidepressants called tricyclics. These medicines have largely

fallen out of favor because of the damage they can do to patients'

hearts and the risks that result from overdoses.

The warning was extended to them in part because of the " great risk

in scaring clinicians back to the tricyclics, " said Dr.

Laughren, a top agency official. ......... "

from the NewYork Times

Doctors Say They Will Cut Antidepressant Use

New York Times

Psychiatrists, pediatricians and family practice doctors said in

interviews that they would restrict their use of antidepressants in

the wake of a federal advisory committee's decision that the

medicines should contain severe warnings about the risks of suicide.

Dr. Lerman, a child and adolescent psychiatrist in New

York City, said that he would no longer prescribe the medicines to

some children and that for the rest he would sit down with their

parents and discuss in detail the risks of the drugs.

The advisory committee made its recommendation after reviewing

numerous studies of antidepressants. Although no children in any

study of the drugs committed suicide, there were reports of

increased suicidal thoughts and behavior. The risks are greatest in

the first weeks of therapy.

" Some parents are very uncomfortable with their kids being on

medication to begin with, " Dr. Lerman said, " and this will be enough

so that some parents will not allow their kids to be on medicines. "

Meanwhile, top officials at the Food and Drug Administration have

decided to re-evaluate whether the drugs can cause adults to become

suicidal, too. Dr. Janet Woodcock, the agency's deputy commissioner

of operations, said in an interview that for years the F.D.A. had

largely evaluated the risk of suicide in adults by analyzing the

final outcomes of antidepressant trials. That analysis has shown no

link to suicide or suicidal behavior, she said.

But the agency identified the risk of suicidal thoughts and behavior

in the trials involving teenagers and children by analyzing in a new

way the adverse-event information provided with the trials. The

agency is now gearing up to do the same thing in its adult trials, a

database that includes 234 tests with more than 40,000 patients.

" I think there might be more to be learned, based on what we learned

from the pediatric studies, " Ms. Woodcock said.

In the meantime, doctors will have to struggle with how to treat

depressed children and teenagers. There are few good options. While

data from 24 studies of nine drugs provided wildly different

estimates of each drug's benefits and risks, the advisory committee

decided that the studies were so small that there was no convincing

evidence that any drug was safer than another. And studies that

included one-on-one talk-therapy failed to show any benefit for that

treatment.

The advisory committee decided that the suicide warning should also

be placed on the physician prescribing sheets for an older set of

antidepressants called tricyclics. These medicines have largely

fallen out of favor because of the damage they can do to patients'

hearts and the risks that result from overdoses.

The warning was extended to them in part because of the " great risk

in scaring clinicians back to the tricyclics, " said Dr.

Laughren, a top agency official.

Indeed, committee members openly worried throughout their

deliberations that their decision might lead some physicians to stop

treating depression in children and teenagers. In interviews, some

clinicians said the committee's push for a warning had done just

that.

" I can tell you that my writing for antidepressants for kids has

dropped off dramatically, " said Dr. Kennedy, a family

practice physician in Augusta, Ga.

" It used to be that when I saw a kid who was 14, 15 or 16 and who

was really down, I felt very comfortable writing them an S.S.R.I.

prescription, " Dr. Kennedy said, referring to a class of

antidepressants. " I don't now. "

Whether antidepressant prescriptions for children and teenagers will

really decline is unclear. In March, the F.D.A. issued a vaguely

worded warning about suicide risk, and it had no impact on

prescriptions trends, agency officials said. Nearly 11 million

prescriptions for antidepressants were given to children and

teenagers in 2002, and that total has since been growing steadily.

In

the first six months of this year, the number of such prescriptions

grew almost 8 percent.

Indeed, worldwide sales of antidepressants in the 12-month period

ending in March were $19.97 billion, according to IMS Health, a

pharmaceutical information and consulting company, making them among

the biggest selling drugs.

Most physicians have written scores of prescriptions for the pills

with no ill effects. And since doctors are unable to distinguish

between a drug and a placebo effect, many feel the drugs work quite

well. In fact, the drugs have by and large not proven any more

effective in children and teens than placebos, and even in adults

prove better than placebos in only half of all studies.

Still, the warning that the advisory committee is recommending, a so-

called black-box warning on the label that explicitly talks of the

suicide risk, is a serious precautionary measure, and physicians

said in interviews that the promise of such a warning has gotten

their

attention. The risk of suicide from the drugs is small. If 100

children and teenagers are given the drugs, two or three will become

suicidal who would not have been suicidal if given placebos.

Dr. Albert Melaragno, a pediatrician in Valencia Calif., said that

five years ago he never prescribed antidepressants. But, Dr.

Melaragno said, the scarcity of psychiatrists and the growing

unwillingness of managed-care plans to pay for mental-health

services has thrust the task of dealing with depressed children and

teenagers

onto him.

The new warning will lead him to be more cautious in using the pills

and more likely to refer patients to psychiatrists, he said. But he

feared that many patients who need the medicines will now refuse

therapy.

" It's raised such a specter with patients that more of the teens who

have the need for treatment will be frightened off of using it and

suffer more because of that, " Dr. Melaragno said.