Posted: 29 September 2005 at 4:14pm | IP Logged

By JOHN J. LUMPKIN, Associated Press Writer

WASHINGTON - 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. Thomas 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 percent 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 percent 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 percent of school-aged children and 4 percent of adults in the United States.

Strattera's worldwide sales have dropped lately, falling 31 percent 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."

Associated Press reporter Ashley M. Heher in Indianapolis contributed to this report.

FDA: http://www.fda.gov

Eli Lilly & Co.: http://www.lilly.com/

Posted: 29 September 2005 at 7:21pm | IP Logged

They said that they had no information about Straterra having this effect in adults. But that just means they had no adults in a study. When I was first diagnosed (at age 45) I was prescribed Straterra. I had several strange side effects. But after about two months of use, I started waking up in the middle of the night with strange nightmares. Eventually I started to feel desperate and began to wake up in the middle of the night feeling desperate and panicked. I started to think about dying.

I think this stuff may work great for some people, but it has a very bad effect on others.

Posted: 29 September 2005 at 10:54pm | IP Logged

My 11 year old son was just put on Wellbutrin and I was told that this drug may bring on suicidal thoughts...but that he has shown no "suicidal tendencies" he should be fine. Since then, he has carved into his bed frame "I hate myself"...and has admitted to us he is mad and sad. I am beyond feeling like this is an "attention" getting behaviour and is something that needs to be properly diagnosed. He was diagnosed with ADHD, which I am sure he has based on his compulsive behavior, inappropriate reactions and social behavior... I am not apposed to having him on a medication to curb these symptoms he has...I just want to know who else has had kids perscribed meds for ADHD, the other symptoms these kids may have had (especially bed wetting...) and how they approached it and what has worked.

Any response or help is appreciated

Posted: 30 September 2005 at 6:26am | IP Logged

I recently pulled my (10 year old) son off of Strattera. He was on it for about 9 months and things seemed fine but recently he started getting very violent.  Biting one sister, and stabbing another with a pencil.  Then he started talking about stabbing himself.  When we talked to him he could not really tell us what was going on.  Just that he started wanting to hurt people and himself.  He was andry and sad all the time. When I was talking to family about it by brother mentioned that my nephew had the same problem with Strattera.  This all seemed happened like in 1-2 weeks; the sudden violence, the talk and talking with family.  We took him right off of it and he is back to his usaul annoying self.  I never thought I would be happy to see that.  It scares me to think how long he has had to deal with this himself before he started showing out ward signs.

In response to TTTmom,  I started with a neurophsycologist.  He diagnoised my sn with severe ADHD and Dyslexia.  He recommended a counselor.  We tried on and all he did was hand out meds.  So we tried another and another.  Finally we found a woman counselor that not only hands out meds but listens to my son and what is going on.  When we thought we got his meds undercontroll and he was doing great we stopped going to her regularly; our normal PCP started perscribing his meds but we are going back.  I guess the only advise I can give is 1. get him tested - it may not be ADHD, 2. find a good counselorand 3. stick with them.  The only constant you will find is these kids are always changing, what works today will not work tomorrow.  Sometimes they change a little at a time you don't notice but a professional should.

Good Luck!

Charna

Posted: 30 September 2005 at 10:35am | IP Logged

Our couselor must actually be a psycologist (MD), but she doesn't just hand out drugs, she takes the time to talk to our son.  That makes a huge difference from the first guy who charged us $20 (copay) for 10 seconds of his time while he weighed him and wrote the script.

The Dr told us the same thing about Strattera is that it was not effective in most children.  We found Strattera was not effective alone.  Or more accurately it was not sufficiently effective but combined with Concerta it took the edge off the times the Concerta wasn't working (i.e. first thing in the morning and as soon as he got off the bus)and a few time we were able to go through the weekend with only the Strattera.

Call me a selfish mom but I was really hoping it would work so we did not have to 1. use a stimulant on him (controlled substance) 2. get a written script each time and 3. use mail order meds.  Copays are killing me but thank goodness for insurance. 

Charna

Posted: 30 September 2005 at 3:33pm | IP Logged

This just shows what I've always stressed to both adults and parents of ADHD children.  You MUST combine the meds with close and careful monitoring by a qualified professional!!

The box already showed many warnings - including that it can stunt the growth of adolescent children.  Any med that works on the mind must be followed carefully.  Many think it's like aspirin - just pop it and keep moving.  I personally had to remind my own MD that my dexedrine had to be monitored for the side effects initially.  So we must all go a little further to make sure we all stay safe.

- Glen