British Warning on Antidepressant Use for Youth - 12.11.03 - NYT

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This is positively pathetic. Help like this we don't need--

December 11, 2003

British Warning on Antidepressant Use for Youth

By ERICA GOODE

British drug regulators yesterday recommended against the use of all but one

of a new generation of antidepressants in the treatment of depressed

children under 18.

In a letter sent to doctors and other health professionals, the government

regulators said a review of data on the safety and effectiveness of the

drugs, known as S.S.R.I.'s, indicated that their benefits did not outweigh

their potential risks.

Their effectiveness in treating depression in children, they said, has not

been sufficiently demonstrated, and some drugs have been linked with

suicidal thoughts and self-harm in children and adolescents. A summary of

the findings was published on the Web site of the British Medicines and

Healthcare Products Regulatory Agency (www.mhra.gov.uk).

The agency, the equivalent of the Food and Drug Administration in the United

States, said it was issuing a strong signal to doctors but was not barring

the drugs completely because there were cases when their use might still be

warranted.

The agency exempted Prozac, from Eli Lilly, but recommended against the use

of six drugs: Paxil, from GlaxoKline; Zoloft, from Pfizer; Effexor,

from Wyeth; Celexa and Lexapro, from Forest Laboratories Inc., and Luvox,

from Solvay.

The F.D.A. is investigating whether the data support a link between suicide

and the S.S.R.I.'s - selective serotonin reuptake inhibitors -in children

and adolescents. On Feb. 2, an advisory committee for the agency will hold

public hearings on the issue. But Dr. Katz, director of the division

of neuropharmacological drug products, said that for many reasons, finding

whether such a link exists was no easy task. " Our view at the moment is that

the risk is not particularly well-understood or defined, " Dr. Katz said. " It

is not at all a straightforward matter to figure this out. "

He said there was no indication that the British regulators had access to

any studies beyond those already under review by the F.D.A.

In June, the American agency warned doctors that they should not prescribe

Paxil for depressed children and adolescents until it had sorted out the

issue. In October it issued a health advisory noting that doctors should use

caution in prescribing S.S.R.I.'s to young patients and should closely

monitor those taking the drugs.

Only a few of the drugs - including Prozac, Paxil and Zoloft - have been

tested in large trials as a treatment for depression in young people.

One big problem for outside researchers, and for the public, is that the

data that seems to show a link between the drugs and suicide is privately

held by drug companies, though it has been provided to the government

agencies.

Even for those who have the data, determining if a link exists is

complicated, Dr. Katz and other experts said, because it is not always clear

that the patients described as suicidal actually are. For example, experts

say, some teenagers may cut or harm themselves but do not intend to commit

suicide.

There are no reliable estimates of how many American children and teenagers

are on antidepressants, but studies indicate the number has risen sharply

over the past decade. Experts on the British agency's advisory committee

estimated that 40,000 Britons under 18 were taking such drugs, with about

half taking Prozac.

The British agency exempted Prozac, the regulators said, because studies

have shown it to be effective for treating depression in children and

adolescents.

Some experts said the British action was extreme.

" I think they're really overreacting, " said Dr. A. Lieberman, a

professor of psychiatry and pharmacology at the University of North

Carolina. " This is really going way too far, and in the process doing more

harm than good. "

Dr. Shaffer, a professor of psychiatry and pediatrics at Columbia

University who sent a letter on the issue at Pfizer's request to the British

drug agency, said he had concluded that there was insufficient data to

restrict the use of the drugs in adolescents. " The bottom line is that

suicidal ideation and suicide attempts are very common in depressed kids, "

he said.

Dr. Healy, of the University of Wales College of Medicine, who has

been outspoken about the need for more unbiased testing of antidepressants,

said the British agency had not addressed larger questions about the drugs.

" The issue isn't necessarily that these drugs should be banned for

children, " he said. " The question is, `What is the safest way they can be

used?' "

Other researchers said the British action was helpful in calling attention

to the unanswered questions about the effectiveness and safety of

antidepressants for children.

" Right now there is a large question of whether the standard of treatment

for children diagnosed with depression " should be the inhibitors, said Dr.

Magno Zito, associate professor of pharmacy and medicine at the

University of land.

Alison Langley, a spokeswoman for the British agency, said the

recommendation was issued because the drugs " don't work in the majority of

cases for children under 18 with depressive illnesses. "

Although the regulators cautioned doctors that the S.S.R.I.'s should not be

prescribed " as new therapy, " they added that if a child was already taking

one of the drugs and doing well, " the normal completion of the planned

treatment course should be considered as an option in the management of the

illness. "

They also said that the drugs might still be appropriate for some children -

those who cannot tolerate Prozac, for example - and cautioned only that in

such cases the medication should be prescribed and supervised by a

specialist rather than by a general practitioner.

In addition, the regulators noted that their recommendation did not apply to

the use of Luvox and Zoloft for children and adolescents who suffered from

obsessive-compulsive disorder, citing research that demonstrated the

effectiveness of the two drugs for the condition.

Children and adolescents who are currently taking the drugs, the regulators

cautioned, should not stop taking them abruptly or change their treatment

without medical supervision.

Timmons contributed reporting from London for this article.