Taken from the Lilly News website:

September 29, 2005

INDIANAPOLIS, Sept 29, 2005 /PRNewswire-FirstCall via COMTEX/ -- Eli Lilly and Company (NYSE: LLY) today announced that it will update the product label globally for its attention-deficit/hyperactivity disorder (ADHD) medication, Strattera, to communicate new information regarding uncommon reports of suicidal thoughts among children and adolescents. In conjunction with a request from the U.S. Food and Drug Administration (FDA), Lilly submitted to regulatory agencies an analysis of adverse event data from its Strattera clinical trials database that identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents (5 cases out of 1357 patients or 0.4 percent vs. 0 cases out of 851 patients taking placebo). There also was one case of a suicide attempt in a patient taking the medication (out of 1357 patients). There were no suicides among children, adolescents or adults on the medication during any Strattera clinical trials, and there was no indication of an increased risk of suicidal thinking in the adult population. As part of the FDA's continuing focus on patient safety, the agency and its Pediatric Advisory Committee plan to complete an ongoing review of adverse event data for all ADHD medications by early 2006.

In the United States, Lilly will add a boxed warning to the product label and is working with the FDA to finalize the product label content as well as information for healthcare professionals. Lilly is also working with other regulatory agencies where the product is currently approved regarding this safety information. In Europe, the information will be provided under the special warnings and precautions section of the product label. In Australia, it will appear as a precaution.

"Lilly's top priority is to help doctors, patients and their families make informed treatment decisions, so we are reaching out extensively to educate physicians and the public about this product label change," said Alan Breier, M.D., vice president and chief medical officer at Lilly. "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. Also important for parents to know," he said, "is that 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."


Full Strattera Press Release (http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=175142)


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Regardless if age, if you are experiencing suicidal thoughts while taking Strattera, consult the prescribing doctor ASAP.

I think the suicide warning is being used with many antidepressants. Strattera was conceived as an antidepressant, but later marketed for ADD.

Tim,

Thanks for posting that info. I had an allergic reaction to Straterra and ended up in the ER for 4-5 hrs.

Shortly thereafter, I ended up on short-term disability.

This time around, the culprit wasn't Straterra and I took vacation time to keep from having to go on short term disability again.

Antidepressants-Suicide Risk (http://www.cbsnews.com/stories/2004/10/15/health/main649559.shtml)

AP) Antidepressants should come with the nation's strongest warning — in a black box on the label — that they can sometimes spur suicidal behavior in children and teenagers, the government's scientific advisers decided Tuesday.

It's a rare risk, and therefore families need detailed information on how to balance that concern with the need to treat depression, which itself can lead to suicide, cautioned advisers to the Food and Drug Administration.

So antidepressants prescribed to minors also should come with an easy-to-read pamphlet that explains how to decide if the child is an appropriate candidate for the drug and what are the warning signs of suicide, the panel concluded. Also, FDA should consider the extra step of making parents sign a form that they understand the risks before the child receives the first pill.

There may be a backlash to such strong warnings, cautioned FDA advisory committee chairman Dr. Wayne Goodman, psychiatry chairman at the University of Florida.

"It will make prescribing more difficult. I anticipate there will be alarm from parents and the child," said Goodman, who still backed the big step. "I think that's worth that complication, because it will raise the threshold to prescribing" these drugs to minors.

On the other hand, the drugs seem to help some desperately ill children, said panelist Jean Bronstein, a California nurse who opposed the black-box warning.

"The biggest message I heard from the consumer is they want to be warned about what the risk is," she said, referring to hours of emotional testimony Monday from families who blamed their children's suicides on drugs they didn't know might be risky.

Tearful families greeted Tuesday's decision with applause.

The FDA isn't bound by its advisers' recommendations, but it usually follows them and has indicated it is eager to update the outdated warnings on today's anti-depressant labels. They state that a link between suicidal behavior and antidepressants hasn't yet proven.

The FDA's latest analysis marks a sharp reversal of that position: For every 100 youths given an anti-depressant, two or three may display increased suicidal thoughts or behavior due to the drug.

The controversy erupted last year, when British health authorities declared that most popular antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. They declared all but one — Prozac — unsuitable for depressed youth, but stopped short of a ban.

The FDA stresses that 24 studies of 4,000 youths found none who killed themselves.

Still, in March, the FDA strengthened anti-depressant labels to urge close monitoring of patients for suicide warning signs, including increased agitation or hostility, especially when they first start the pills or change a dose.

It called this week's two-day meeting to see what other safety changes are needed.

Some studies suggest a greater risk for certain drugs, such as Effexor, and initial worries about antidepressants focused on a newer drug family called SSRIs.

"We are unable to conclude that any single agent is free from risk at this time," FDA's advisers voted unanimously, urging that new warnings cover all antidepressants given to children. That's because studies of the issue so far are small and flawed.

©MMIV, The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.


FDA Alert (http://www.fda.gov/cder/drug/InfoSheets/HCP/atomoxetinehcp.htm)

This topic has been widely discussed at the community mental health center where I work.

The consensus of opinion is that in some cases, the increased (physical & emotional) energy and improved mood derived from the medication(s), are what helped potentiate the gesture or attempt.

... "We are unable to conclude that any single agent is free from risk at this time"... That's because studies of the issue so far are small and flawed.

This is a fequent critcism leveled at these kinds of studies. However, it is important to realise one of the major reasons the studies are so small and short term: It is considered unethical to do long term double blind studies where the health and well being of people suffering from a disease or disorder is concerned because you would have to deny the control group access to what may turn out to be a life changing or life saving treatment.

Scientists and Doctors are caught in a catch 22 situation. They cannot successfully answer all the questions and still act ethically. So, we end up with short term studies which lay out some of the more apparent short term bad side effects, and watch carefully for signs of the longer term effects of the treatment.

Studies are often sabotaged by high drop out rates in which case the researchers publish what data they can salvage and note the problems with the studies.