FYI Strattera Suicidal Warning

[milesofsmiles]

Found this article this morning. Looks like the real deal.

Miles

CHICAGO (Reuters) - Eli Lilly and Co. on Thursday said it will add strong warnings to its label for Strattera, used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents. Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.

Lilly said there were no suicides among children, adolescents or adults taking the medication during Strattera clinical trials, but there was one suicide attempt in a patient taking the drug.

The warning came after the U.S. Food and Drug Administration requested Lilly to submit an analysis of adverse event data from its Strattera clinical trials data base, which identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.

Lilly said it is working with the FDA to finalize the product label. It also is working with regulators outside the United States.

Lilly backed its prior sales and earnings outlook for the year and said it expects to report full-year 2005 earnings per share of $1.90 to $1.96.

ADHD affects 3 to 7 percent of school-age children and manifests itself in inappropriate levels of attention, concentration, activity, distractibility and impulsivity.

[Kaiti]

Thanks for the information Miles.

We really need to watch how our children react to just about anything these days. You guys know that I modify Mikey's diet, but some days are just harder then others for him

Even with the bully intervention programs that they do in school, we as parents need to watch for key behavior changes all the time. Not only to prevent suicide, but to to keep our kids self esteem at a healthy level so it won't lead to any drastic behavior.

[Linda]

milesofsmiles said:

Found this article this morning. Looks like the real deal.

Miles

CHICAGO (Reuters) - Eli Lilly and Co. on Thursday said it will add strong warnings to its label for Strattera, used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents. Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.

Lilly said there were no suicides among children, adolescents or adults taking the medication during Strattera clinical trials, but there was one suicide attempt in a patient taking the drug.

Probably is the real deal....but I would have to know more about the patient taking the drug.

[Blue Oreo]

I just got my DD off Strat this week , she is in her final "ween" down phase for it. I got her Concerta and OMG the difference was almost instant. MAN I love 8-)this new med, she is HER OLD SELF again , happy, outgoing and the ADHD behaviors are gone. Along with the OCD, ODD is well under control. This is the miracle drug I have been waiting for.. WOOHOOOOOOOO ;D

[AnneM]

Thanks Miles ...

I would really like to know whether the "possible increase in suicidal tendancies" is just around the time when the 'benefits' just begin to kick in (as is the findings in reports with some of the antidepressants - and of course Strattera DOES contain antidepressants! .. OR whether the findings are more widespread ... (i.e. there is an increase regardless of how long the person has been taking strattera) ...

If I was the parent of a child on strattera I would REALLY want to know the answer to this ...

Also the "No suicides" during the clinical trials but ONE reported suicide afterwards (and who is to say that that poor individual would not have done this ANYWAY!) doesn't really give me (personally) enough information or reason to reject strattera ...

In other words if my child was on strattera and doing well .. this would in no way give me enough evidence to remove him/her from strattera ... I think they need to come up with a LOT more evidence than "no suicides during clinical trials and ONE afterwards!!"