Posted by theo on December 19, 2004, at 13:07:50
I find this interesting, at least I know it's not my imagination on cognitive impairment and Lamictal. Have you guys seen this? What's your opinion?
CORRECTIVE STATEMENT
At the request of the MHRA GlaxoSmithKline (GSK) have been asked to provide a corrective
statement regarding the promotion of Lamictal.
During the first quarter of 2004 GSK issued advertising materials for Lamictal containing a
reference to cognitive function. Subsequently, at the request of the MHRA, GSK voluntarily
withdrew these materials.
The advertisements were considered to be misleading since they indicated that the product did
not impair cognitive function, however, listed in section 4.8 of the Summary of Product
Characteristics (SPC) were adverse events that may impair cognitive function, such as dizziness,
drowsiness, confusion and hallucinations.
By disregarding these adverse events, the advertisements did not present an objective view of the
product and exaggerated its properties.
We regret that messages contained in these advertisements were not perceived as intended and
apologise for any confusion that may have been caused by them.
Should you have any further questions about these matters or about Lamictal please contact the
GSK Customer Contact Centre, freephone 0800 221441, fax 020 89904328 or email
customercontactuk@gsk.com.
poster:theo
thread:431662
URL: http://www.dr-bob.org/babble/20041217/msgs/431662.html