Saturday, October 15, 2005

FDA Issues Alert on ADHD Drug Strattera

FDA Issues Alert on ADHD Drug Strattera


Trials find link between medication and suicidal thoughts in children By
Amanda Gardner, HealthDay Reporter

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THURSDAY, Sept. 29 (HealthDay News) -- The U.S. Food and Drug
Administration warned Thursday that the drug Strattera, which is used to
treat attention-deficit hyperactivity disorder (ADHD), may prompt
suicidal thoughts in children.

The agency directed the drug's manufacturer, Eli Lilly & Co., to add a
black box warning -- the most serious alert -- to the medication's
label. Lilly will also develop a patient medication guide.

The warning followed an analysis of a dozen clinical trials involving
Strattera. About five patients reported suicidal "ideation," or
thoughts. One participant attempted suicide, the FDA said.

"The signal is really for ideation," said Dr. Thomas Laughren, director
of the FDA's division of psychiatry products. "The concern is that
ideation is related to attempts and ultimately completed suicides, so we
think it's something that clinicians and patients need to be alerted to
so that the patients who are treated with this drug can be observed
fairly closely."

"FDA still considers Strattera an effective medication that should be
part of the armamentarium that can be used and should be used," Laughren
added. "We think that this new information will make it possible to use
it in a safe manner."

"The real issue is that suicidal thoughts are common, if not normal, in
teenagers," said Dr. Harold Koplewicz, director of the New York
University Child Study Center. "Nineteen percent of teenagers report
that they have suicidal thoughts. Thats about one in five. Also, the
linkage between suicidal thoughts and suicide is tenuous at best. While
19 percent of American youth are thinking about suicide, .008 percent
actually commit suicide."

This is not to say that prescribing psychiatric drugs should be taken
lightly, he added. "This is another indication that psychiatric
medication cannot be given without thought, without an evaluation,
without a diagnosis and, most importantly, without monitoring,"
Koplewicz stressed. "That doesn't mean that every child and adolescent
that gets it has to get it from a child and adolescent psychiatrist, but
it does mean that pediatricians and primary-care physicians need to be
aware that there is some risk."

Strattera is approved in the United States to treat ADHD in children,
adolescents and adults. As many as five of every 100 American children
may have ADHD, according to federal estimates. Boys are three times more
likely than girls to have the condition. Strattera, on the market since
2002, it has been used by more than 2 million patients.

ADHD medications are amassing a complicated history. In February, Health
Canada ordered Adderall XR off the market after reports of sudden
cardiac death in 20 patients. The FDA, however, only required the
manufacturer -- Shire Pharmaceuticals Group -- to update Adderall's

In July, an FDA advisory committee considered, but ultimately rejected,
labeling changes for a class of stimulants called methylphenidates that
includes Ritalin and Metadate. Panel members also suggested that the FDA
wait to make any changes until more safety data had been collected on
two other types of drugs used to treat ADHD -- amphetamines such as
Adderall and Strattera, a non-stimulant.

The review of psychiatric adverse events in Strattera and amphetamine
products was not scheduled until early 2006.

The Strattera information came out earlier, largely because of recent
controversy over the use of antidepressants in children. Last year, the
FDA asked all antidepressant manufacturers to add a black-box warning to
their products prescribed for children.

"Strattera has some pharmacological similarities to antidepressants and,
because of that and our concern that there might be a signal lurking
there, we asked the company in December of last year to do a similar
search of their database to look for suicidality," Laughren explained.

That report came in several weeks ago, and was the basis for Thursday's

In the review of 2,200 patients, 1,357 of whom were taking Strattera,
researchers found that 0.4 percent of the children taking the drug
reported suicidal thinking, compared to no cases in children taking a
placebo. There was also one suicide attempt in the Strattera group, the
FDA said.

"The absolute risk of emergent suicidality in this database is quite
low. We're talking roughly four per 1,000 treated patients," Laughren
said. "Very few individual patients would be expected to have emergent
suicidality based on this analysis. But, from a public-health
perspective, when you're talking about tens or hundreds of thousands,
that could be a large number of patients. We don't know exactly what the
signal means."

The black-box warning and patient medication guide, which will focus on
ideation but also include mention of the suicide attempt, are expected
to be completed within a few weeks. "We expect to resolve this quickly,"
Laughren said.

More information

Visit the National Institute of Mental Health for more on ADHD.

content by:

SOURCES: Thomas Laughren, M.D., director, division of psychiatry
products, U.S. Food and Drug Administration, Rockville, Md.; Harold
Koplewicz, M.D., director, New York University Child Study Center and
author, More Than Moody: Recognizing and Treating Adolescent Depression,
Sept. 29, 2005, FDA advisory statement

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