/24-7PressRelease/ - HAGERSTEN, SWEDEN, April 05,
2006 - The "ADHD medication" Strattera is not
approved in Sweden. Eli Lilly decided to do a
one-year clinical trial of the drug on children. The
purpose of the study was to get Strattera approved
by the Medical Products Agency (MPA). The company
hired the psychiatric authority Bjorn Kadesjö to
lead the trial.
The 100 participating children and their parents
needed information about the adverse effects of the
drug in order to sign the consent form. They thought
they got it. They did not.
Eli Lilly deliberately withheld information about
disastrous effects of Strattera - information which
could have made the parents and children want to
withdraw from the study; information which could
have made the Regional Ethical Review Board want to
disapprove the application; information which could
"disturb" the result of the trial.
The "updated" information given to parents and
children about adverse effects was from January 31,
2005. The only serious adverse effect mentioned was
liver injury in very rare cases.
But documents now made public show that Eli Lilly
knew about several serious effects from Strattera at
Take the FDA report Psychiatric Adverse Events
Associated with Drug Treatment of ADHD: Review of
Postmarketing Safety Data, released for the FDA
Pediatric Advisory Committee meeting, March 22. It
says that Eli Lilly (and other pharmaceutical
companies) were asked to provide information about
a) signs and/or symptoms of psychosis or mania; b)
suicidal ideation and behavior; c) aggression and
violent behavior, (for Strattera for the period
November 2002 - June 2005). In that period Lilly had
received 350 reports of psychosis or mania, 900
reports of aggression and violent behavior and 400
reports of suicidality. In a Preliminary Assessment
Report from December 2005, written by the British
medical regulatory agency MHRA, it is mentioned that
Lilly from November 2002 to September 2005 had
received 766 reports of heart disorders connected to
the use of Strattera. (It should be noted that
credible estimates of the percent of adverse
reactions that are reported range from 1-10%.)
It is certainly not so that Eli Lilly had received
these reports in the period February - June 2005.
Almost all of reports had been received in the
foregoing 26-month period and only a minor part in
the 5 month up to June 2005.
This means that Eli Lilly deliberately withheld
Strattera's disastrous effects of psychosis and
mania, aggression and violent behavior, suicidality
and heart disorder, in the information to parents
and children in the clinical trial.
writer from Sweden - investigating psychiatry