ADHD drug may cause suicidal thoughts

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ADHD drug may cause suicidal thoughts

USA TODAY 9-28-2005

WASHINGTON (AP) — The Food and Drug Administration

warned doctors Thursday about reports of suicidal

thinking in some children and adolescents who are

taking Strattera, a drug used to treat attention

deficit hyperactivity disorder.

Manufacturer Eli Lilly & Co. announced that a

black-box warning will be added to the drug's label in

the United States. Such a warning is the most serious

that can be added to a medication's label, and similar

warnings will be added to the drug's labels in other

countries. The company said a study showed instances

of suicidal thinking were rare.

In a statement, the FDA said it " is advising health

care providers and caregivers that children and

adolescents being treated with Strattera should be

closely monitored for clinical worsening, as well as

agitation, irritability, suicidal thinking or

behaviors, and unusual changes in behavior, especially

during the initial few months of therapy or when the

dose is changed. "

Eli Lilly said it provided the FDA results from

Strattera clinical trials of 1,357 patients that found

five youths taking the medication reported having

suicidal thoughts, while none of 851 patients taking a

placebo reported having any. One young person taking

Strattera attempted suicide, but survived, company and

FDA officials said.

There was no evidence of increased suicidal thoughts

in adults taking Strattera, which also goes by the

generic name atomoxetine, the Indianapolis-based

company said.

" The actual risk is very low, " said Dr.

Laughren, head of the FDA's psychiatric drug unit.

Despite the warning, he said, " FDA still views

Strattera as an effective drug. "

At the FDA's request, Eli Lilly will publish a guide

for doctors and pharmacists to give to people who are

prescribed Strattera.

The warning is the result of a larger FDA review of

psychiatric drugs and their possible association with

suicide, the agency said. Old drug studies are being

reviewed for occurrences of suicides and suicidal

thoughts. Last year, the FDA ordered warnings on all

antidepressants that they " increase the risk of

suicidal thinking and behavior " in children who take

them.

Strattera won praise from some doctors and parents

when it became available because, unlike Ritalin, it

is not a stimulant, a class of drug that can be

addictive. But its chemical makeup is similar to

certain antidepressants.

A review of other ADHD drugs is continuing, Laughren

said.

About 3.4 million patients — adults and children —

have been prescribed Strattera since it became

available, with Lilly officials saying about 75% of

those taking the medication are children.

Dr. Harold Koplewisz, a professor of child and

adolescent psychiatry at the New York University

School of Medicine, said that 19% of all teenagers

have suicidal thoughts, making " suicidal thoughts in

adolescents part of the normal experience. "

" There are 2,400 adolescents thinking about suicide

for every one that commits suicide, " he said in an

e-mail. " We are talking about a medication that may

make some children and teenagers uncomfortable, which

is very different than a lethal situation like a gun

in a house. "

Still, he said, all children and teens taking

psychiatric medication should be monitored.

Attention deficit hyperactivity disorder affects as

many as 7% of school-aged children and 4% of adults in

the United States.

Strattera's worldwide sales have dropped lately,

falling 31% to $123.5 million during this year's

second quarter from a year earlier.

Lilly warned doctors in December to stop using

Strattera in patients with jaundice or who show signs

of liver problems, and it placed a warning on the

label and in prescribing information after at least

two patients on the medication developed liver

problems.

The company said Thursday it believes the drug is

safe.

" While suicidal thinking was uncommon in patients on

the medication during clinical trials, it is important

for parents to be aware it can occur, and to discuss

any unusual symptoms with a physician, " said Alan

Breier, Lilly's chief medical officer, in a statement.

" Lilly continues to view Strattera as a safe and

effective treatment option, and those doing well on

the medication should be able to continue their

treatment with confidence. "

Dr. DeSiena, D.C.

Washington Street Chiropractic Center, L.L.C.

771 Washington Street

Eugene, OR 97401

(541) 686-BACK (2225)

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