'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 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.

Suicidal Thoughts Common in Teens

"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."

ADHD Meds: Complicated History

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 label.

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 warning.

One Suicide Attempt

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.