All Press Releases for November 20, 2006

ADHD drug Strattera - new warnings, but the British MHRA didn't care to investigate 600 cases of suicidality and 12 000 "psychiatric reactions"

The British medical agency MHRA will soon issue new warnings for Strattera but didn't care to investigate the reported 12000 "psychiatric reactions" from the drug. And even if number of reports of suicidality has doubled since last year the MHRA has accepted the PR-analysis of Eli Lilly as its own.

    /24-7PressRelease/ - HAGERSTEN, SWEDEN, November 20, 2006 - In its new report about the ADHD drug Strattera, expected to be published by the end of the month, the British Medicines and Healthcare products Regulatory Agency (MHRA) will issue new warnings about the harmful effects of the drug. This time about the risk for sudden cardiac death in connection with Strattera "treatment".

But the report will not take up all the "psychiatric reactions" known by the agency for almost a year. The reason is the MHRA didn't care to investigate them.

In January the agency wrote in its Risk:Benefit Assessment about, what it called, the "large number of psychiatric reactions" from Strattera. It said it had requested Eli Lilly "to perform a cumulative review of all psychiatric disorders reported for atomoxetine [Strattera]".

This review was however not submitted in January and thus was not part of the evaluation done by MHRA at the time.

And still in the beginning of August no evaluation of these, at that time, more than 12 000 reported "psychiatric reactions", had been done. Eli Lilly had submitted no review. The MHRA explained that this would change: It had "asked [Eli Lilly] that it is submitted by 9 August. Upon receipt the data will be considered within Europe and consideration given to what regulatory action, if any, is appropriate."

But no consideration could be given, as Eli Lilly neither this time submitted any review.

As a consequence, in the beginning of September the MHRA announced there would be no review of all these "psychiatric reactions". When Eli Lilly didn't submit any documents to the MHRA by August 9 the agency dropped the request. Instead the agency started to refer to the analysis done by the FDA, considered by the FDA Pediatric Advisory Committee at its meeting on 22 March 2006. However the FDA review covered parts of all these reactions and was completed already in September 2005 - the MHRA knew all about it a long time ago.

This means that the British MHRA, leading the current "safety review" of Strattera in Europe, didn't care to investigate what the agency itself called the "large number of psychiatric reactions". It didn't even get in any biased data about these harmful effects from the manufacturer Eli Lilly.

Warnings that Strattera increase the risk of suicidality were issued internationally in September 2005 after Eli Lilly announced a "new analysis" of its clinical trials of the drug.

The number of reports of suicidality and self-injurious behaviour in connection with Strattera had as of May 2006 reached - 600! The number has doubled since September 2005.

Despite the fact that reported cases of suicidality are now over 600, the MHRA has failed to set up an independent investigation of these horrendous harmful effects.

The agency has - as earlier - just accepted the review of Eli Lilly. The Lilly review from January this year (of earlier cases of suicidality) is an excellent example of how to explain away suicides, suicide attempts and suicidal ideation caused by psychiatric drugs. That the reports of suicidality doubled in just some months has not affected the operation of the MHRA - the agency continues to let the manufacturer explain away the harmful effects caused by the psychiatric drug.

Instead of protecting the welfare of children, the MHRA takes part in the forceful drugging of created young "patients" with the alleged psychiatric brain disorder ADHD (without any objective abnormality).

For the sake of children a full independent review of Strattera and the large number of cases of aggression, hostility, homicidal behaviour and ideation, psychosis, abnormal behaviour, suicides, suicide attempts and suicidal ideation must be done promptly.

Psychiatrists, Eli Lilly and medical agencies should no longer be allowed to hide the harmful effects of the drug.

Janne Larsson
writer from Sweden - investigating psychiatry

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