It also looks like the article was poorly written and suggested that the total number of participants (including placebo) was 1357, while another source said that the number of those receiving the drug was 1357. So I will correct later when I have time.)
When I got home today, my husband had printed this article out and written his notes on it for me. Here were his observations using the numbers in the article:
1357 test subjects
851 given placebo - none with suicidal ideation (SI)
506 given Strattera - 5 with SI - this equals 1% of the group.
3.4 million patients on the drug
75% are children
2.55 million children on Strattera
1% of 2.55 million = 2,550 children will have suicidal ideation because of the drug.
"There are 2,400 adolescents thinking about suicide for every one that commits suicide"
This means 100 or so kids will successfully kill themselves because of Strattera.
FDA Warns About ADHD Drug Strattera
By JOHN J. LUMPKIN,
Associated Press Writer Thu Sep 29, 8:33 PM ET
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."
11 comments:
Let me get this straight. Eli Lilly has marketed a product that, as it turns out, presents a genuine danger to a small but statistically significant group of users. But they still believe the product is “safe and effective.” I’m shocked.
kids with adhd are impulsive. I wonder if the ones who weren't taking any drugs were more impulsive and so more likely to do dangerous things that could get themselves killed? Say like, deciding to try to jump off the roof of the house with a bedsheet for a parachute... or not looking before running into the street.
IF, straterra helped with that kind of impulsivity, it would be good to balance the lives and limbs saved by the controlled impulsivity vs, the increase of suicidal ideation.
That's an IF though, since I don't know if strattera or ritalin or any other drug has been shown to save the lives of otherwise impulsive adhd kids. I'm thinking about my brother who was an adhd type kid and who crawled out on a little bit of roof from a second story window when he was like 2 or 3 years old, but was found in time before he fell or jumped.
He also used to run out in the street. This street had logging trucks running on it regularly. (Idaho)
I appricate the concern, however, I think my son would kill him self with out it. I also understand that anyone taking the drug who does anythig abnormal, or for somereason gets a secondary medical condition, all of the sudden it is the medication's falt. I think we should really take a good hard look at and the facts, and mabe there may be some other underlying causes. But because it happens, now they have to say, that as a warrning
I have a 10 year old with Autism and I love the fact that strattera is a non-stimulant drug. He is very impulsive, a loner, picked on all the time. He is already at risk for SI. I say be conserned let Eli Lilly know our conserns. Let other people be conserned. But don't go on a drug company bashing kick. I am afriad they will stop search for help for our kids.
"1% of 2.55 million = 255,000 children will have suicidal ideation because of the drug."
Apparently basic arithmetic is not a required subject for John Hopkins training. That's 25,500, not 255,000. :(
fixed... thanks for the heads up.
Also it was 1357 receiving Strattera in the test. Meaning the percentage is actually more like 0.4%. So 2.55 million x 0.4% is 10,200 rather than the 255,000. So using the 2,400 reconning number that works out to 4-5 kids that could commit suicide (assuming extra vigilance doesn't help avoid those tragedies).
Sad indeed but comparing to your original post ... well the difference is very, very stark. Considering that's about 1 in 500,000 odds that does certainly warrant the "safe" language.
Edit from prior post removing inappropriate snippiness.
Husband has been fired from one day guest blogger statistician stint three years ago.
Will have to fall back on previous career as TV producer where he can't harm the pharmaceutical industry.
LOL
Christmas is coming up. Maybe you should consider buying him a calculator? :)
P.S. There is still the take-away that the use of psychoactive pharmaceuticals, or really anything that can mess with your perception of reality (this includes things like holistic cleanses too), are serious business. More-so with the young, who are likely to have less experience and tools developed to work with. Thus arming yourself with [accurate] knowledge, a plan, and all the help you can muster going in is prudent.
Like the blog. A new reader here. Have a 6 year old son with mild autism.
I don't work for a drug company. I work in the security industry. I believe it's appropriate to point out that suicidal ideation does not equal suicidal death takes place. SI's certainly can lead to suicidal death, and I don't mean to minimize SIs in any way. Each should and must be taken very seriously. But the deduction made "100 plus kids will kill themselves on Strattera" is simply incorrect and inaccurate.
I like what you're doing on the blog, but some parents, like me, are on their 3rd neurologist and are looking up more info. on the internet about Concerta, Strattera and other medications that are being recommended following consultations. Then I come across your post and was rather surprised by the assertion and stretched math.
I'm a realist and a skeptic. I don't trust that anybody knows what their doing 100% with respect to PDD and ADHD. Between Jenny McCarthy, Casein-Free B.S., vitamin therapy, I don't know how anyone can keep buying and buying the bs being shoveled around. I get the "make money" theme.
Everyone makes mistakes. But I just wanted to mention that some people might Google "Strattera", come across your site, and then get the wrong idea from what you've mentioned.
Come on - get the math right!
1% of 2.55 million = 25,500 children will have suicidal ideation because of the drug.
"There are 2,400 adolescents thinking about suicide for every one that commits suicide"
This means 11 (25,500/2400=10.625) or so kids will successfully kill themselves because of Strattera.
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