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----- Original Message -----
From: Janne
To: the mhra
Cc: to dh.gsi.gov.uk and nice@nice.org.uk
Sent: Friday, April 14, 2006 12:17 PM
Subject: Request for data and FOIA request about Strattera's effect on sexual maturation
Request for data and FOIA request about Strattera's deleterious effect on sexual maturation
New information from Eli Lilly Sweden indicates there are known, but not published data about Strattera's deleterious effect on sexual maturation.
In a letter introducing a new version of the parent/children information for the clinical trials of Strattera Eli Lilly writes: "When Strattera was approved by the Norwegian, Dutch and German medical agencies the question came up if treatment with Strattera effects the sexual maturation of children." [Eli Lilly, letter to the Swedish Medical Products Agency (MPA), February 2, 2006.]
The approval of Strattera in Norway, Holland and Germany was done with UK as reference country according to the so called Mutual Recognition Procedure (MRP). This means that the MHRA has full knowledge about the information taken up above.
Eli Lilly euphemistically writes "the question came up" - which in actual fact would mean that strong worries were stated about Strattera's effect on sexual maturation. This in turn means that data pointing strongly in that direction were available for the MHRA.
To my knowledge the public has not at all been informed about these worries. In the SPC for Strattera in UK it is only written:
http://emc.medicines.org.uk/ Strattera: "Clinical data do not suggest a deleterious effect of atomoxetine on cognition or sexual maturation, however, the amount of available long-term data is limited. Therefore, patients requiring long-term therapy should be carefully monitored." All readers must wonder about the background to this mysterious statement.
The MHRA should in keeping with its aim to protect public health make sure that the public is kept informed and updated on drug safety issues. With reference to that aim and to the FOI Act I now request that the known data about Strattera's deleterious effect on sexual maturation are sent to me. I also request that the evaluations (worries) from individual assessors (from UK, Norway, Germany, Holland) about Strattera's effects in this area are sent to me.
I would be pleased if the documents could be sent electronically to this email address:[address]
Yours sincerely
Janne Larsson
