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Accutane/Roaccutane Action Group was established arising from a public meeting attended by individuals and families of individuals, who have suffered, and in many cases continue to suffer, serious side-effects, including psychiatric disorderds attributed and linked to the taking of the acne prescription medication Accutane/Roaccutane.
Accutane/Roaccutane is prescribed in the treatment of mild, moderate and severe acne, mainly to young people in the age group 13 to 23. It may well be the only prescription medication on sale by pharmacists that has attracted label warnings featuring suicide, suicide attempt and suicide ideation as possible side-effects.
The main objective of the Group is to demand
the appointment of an independent national and co-ordinated international
investigation into Accutane/Roaccutane and the manufacturers of the
drug, with free access to all Roche internal documents to study all
aspects of safety data surrounding Accutane, with particular emphasis
on (a) if studies could have shown the depression risk (b) if such studies
had been suppressed by marketing and public relation worries and (c)
if discussion of depression was suppressed in an uethical fashion.
The Committee of R.A.G. was appointed at the Group's first formal public meeting held on January 23rd 1999.
A confidentiality agreement was entered into by the Committee in order to safeguard and protect the identity of members. The agreement provides that confidential information disclosed by members to the Committee, or to individuals on the Committee, shall be treated in the strictest confidence and shall not be disclosed to third parties without the express written consent of the person disclosing the information.
We have overr 2000 members who have suffered severe physical and psychiatric side effects. We are also working with similar groups in the US, Australia, Canada, United Kingdom, France, Norway, Sweden, Italy and South Africa.
We are anxious to make contact with people in every country where the medicaiton is sold who may be willing to provide assistance or who are willing to join as members.
In our view:
Contacts have been established with a number of national and international agencies, to collect all available data on reported adverse reactions in respect of Roaccutane.
Submissions have been made to governments
and national / international health agencies, including the FDA, to
highlight serious side effects and to demand proper independent studies,
which Roche have failed to carry out.
We have commissioned a number of research studies to investigate the link between Roaccutane and depression and to investigate the mechanism by which the drug causes so many serious physical and psychiatric side effects.
We have pursued the establishment of an International Action Group in order to consolidate efforts to provide a unified plan of action to highlight the severe suffering caused by Roaccutane and to forca the appointment of an independent international investigation on Accutane/Roaccutane.
The Committee would appreciate the expertise, assistance, contacts, ideas an help of any kind, from people who support the Group's objectives.
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