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Scientific Studies

Some of the topics covered in this section are as follows:

Why do scientific studies refer to Accutane/Roaccutane as Isotretinoin and/or 13-cis-retinoic acid?
What is Accutane/Roaccutane? How is it related to Vitamin A? What are retinoids?
What is the mechanism of action of Accutane/Roaccutane?
Published cases of psychiatric adverse events, including depression, psychosis, suicide, suicide attempt and suicide ideation occuring in association with Accutane/Roaccutane?
What about biologic plausibility - Are any other retinoids associated with psychiatric disturbance?
Do retinoids (Vitmain A, retinoic acid etc) have a role in the adult human brain?
What research has been conducted to examine the effects of Accutane/Roccutane on the adult brain?
Are meetings being held to discuss the link between Accutane/Roaccutane and psychiatric adverse effects?
Published studies which review the link between Accutane/Roaccutane, depression and suicide
Published studies on retinoids in the central nervous system, the link to depression and other neurological diseases including schizophrenia and alzheimer's and mechanism of action of retinoids
Published epidemological, retrospective and prospective studies linking Accutane/Roaccutane to depression and suicide

Regulatory Authorties

  • Regulatory Authorties - some of the topics featured on this page include:
    What are the names of the Licensing/Regulatory Agencies in the USA, UK, Ireland, France, Canada etc?
    What are the role of the Licensing/Regulatory Agencies?
    What meetings have been convened to discuss the psychiatric side effects of Accutane/Roaccutane?
    What statements/alerts have been released by the Licensing/Regulatory Agencies?
    What warning letters have been issued by Regulatory Authorties/Agencies to the Manufacturer of the drug, Roche and why?
  • Ireland - Irish Medicines Board
  • UK -Medicines and Healthcare products Regulatory Agency (MHRA) - formally called the MCA
  • France -French Health Products Safety Agency
  • For Other European Medical Agencies click here....
  • Canada - Health Canada
  • Australia - Therapeutic Goods Administration

Adverse Reactions

  • Some of the topics on this page include:
    What is the most frequently reported adverse event for Accutane/Roaccutane?
    Ranking of Accutane/Roaccutane compared to other drugs for adverse reports of depression and suicide?
    Comparsion of adverse events reported for Accutane/Roaccutane to other medications?
    Why is it necessary to report adverse events?
    What percentage of adverse reactions are reported?
    Dechallenge/Rechallenge reports?
    Current number of adverse reaction reports on FDA database?
    Reports indicate that an increasing proportion of Roaccutane/Accutane are used for mild and moderate acne?
    Roche report on number of psychiatric events recorded for age group 13-17 between 01 Nov 01 and 31 May 04?
    Report on number of suicides recorded for children under 18 years of age between 1989 and June 2003? How many cases of suicide, suicide attempt and suicide ideation were reported to Roche before the label warning change to include 'suicide' as a possible side effect in 1998?
    How to obtain list of adverse events?
    How to file an adverse event?

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