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Eli Lilly's Strattera had 130 reports of suicidality in one month.

There are new safety concerns about the Attention Deficit Hyperactivity Disorder drug Strattera, widely used in Europe and the United States . It's already been linked to rare cases of liver damage and suicidal thoughts and behaviors.

British authorities have associated Strattera with seizures and a potentially dangerous lengthening of the time between heartbeats, called QT interval prolongation, in a handful of the more than 3.7 million people who have used the drug since it hit the market in November 2002.

The warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency, the United Kingdom 's equivalent to the U.S. Food and Drug Administration.

Straterra Quick Facts:

Strattera's label was updated last fall in Europe and the United States to warn of rare suicidal behavior risks.

Strattera, Eli Lily's "ADHD Medication" earned the company 400 million in 2005.

A discussion paper written by the British Medicines and Healthcare Regulatory Agency, reveals that last fall, there were 130 reports of suicidality in a single month by patients treated with the attention deficit drug Strattera.

The paper also reveals that there have also been more than 760 spontaneous reports of cardiac disorders, 172 reports of liver damage, and about 20 reports of completed suicides.

How Straterra Works

Strattera, the only ADHD drug that is not a stimulant, typically is used as an alternative to drugs like Ritalin, which have been on the market much longer.

Strattera offers two advantages: as a nonstimulant, it has no abuse potential, plus it stays in the body for a few hours longer, so ADHD control is extended into the evening.

Strattera is a Failed Antidepressant

Strattera is a failed antidepressant, which Eli Lilly didn't succeed to get approved. It was recycled and used as an "ADHD medication", and marketed as the first "non stimulant medication for ADHD".

In April 2005 the European Agency for the Evaluation of Medicinal Products (EMEA) issued warnings that Strattera could give " hostility and emotional lability" in children and in September 2005 a Black Box Warning for suicide risk was issued for Strattera.

Straterra Suicidal Reports

In one month (23 September 2005 - 25 October 2005) 130 cases of suicidal and self-injurious behaviour were reported! This should be compared to the 301 cases reported in the period November 2002 - September 2005 - in 3 years. This means that 30 percent of all reports of suicidality were received in one month!

In addition to the suicides and suicide attempts reported, the paper from the MHRA also tells about 766 spontaneous reports of cardiac disorders and 172 reports of liver injury.