International Regulatory Agencies responsible for Roaccutane / Accutane
National EU medical agencies:
Ireland - Irish Medicines Board
UK -Medicines and Healthcare products Regulatory Agency (MHRA) - formally called the MCA
France -French Health Products Safety Agency
Switzerland - Swissmedic
Italy - Agenzia italiana del farmaco
For Other European Medical Agencies click here....
- Health Canada
- Therapeutic Goods Administration
- Food and
drug administration, USA. Information on the FDA website relating
to Roaccutane/Accutane can be found here
World Health Organization
National authorities are responsible for regulation and surveillance of the development, manufacturing and sale of drugs and other medicinal products. National Authorities should ensure that both the individual patient and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner.
In order to obtain a product authorisation (licence), pharmacutical companies are required to submit data in respect of the quality, safety and efficacy of the medicine, in the indication for which the application is made. An authorisation is granted on the basis that it is meets the required standards. As new safety data (from all sources - new studies, literature publications, national/international adverse reaction reports etc) become available over time with increasing experience of a medicine, the regulatory process allows for update of the product information.
The Licensing/Regulatory Agencies are also responsible for monitoring adverse reactions (ADR's).
FDA - Food and drug administration, USA.
The FDA held a public meeting in Washington on the 18th and 19th September 2000 to discuss the psychiatric side effects of Roaccutane/Accutane.
Mr Grant, Chairman of the Roaccutane/Action group made a presentation which can be viewed here (Microsoft PowerPoint Presentation).
The transcripts of the hearing are available from http://www.fda.gov/cder/drug/infopage/accutane/default.htm
MHRA (formally called the MCA)
- The FDA committee voted unanimously for the introduction of a Medication Guide for Accutane- only two other drugs require this mandate.
- The FDA committee voted unanimously that the sponsors, Roche, are to link up with the FDA and NIH to formulate an independent study on the mechanism by which accutane works and to clarify the relationship between Accutane use and psychiatric events. These studies are to include 'basis science studies' and a prospective study. The 'basic science study' is to contain projects which determines the role of retinoids in the adult and adolescent brain and the role of retinoic receptors and related chemicals that may be involved in a pathway with retinoic acid in the brain.
A meeting was held on the 17th May 2002 between the Medical Control Agency (MCA) in the UK and Mr. Grant, Dr. Chow and Mr. David Chow (Members of the Roaccutane/Accutane Action and Support Group). Four representatives (including Dr. J. Raine, Director Post licensing Division) of the MCA were present and the meeting lasted almost three hours. Further basic studies to be financed by the manufacturer, Roche, were called for.Click here for memorandum of meeting
- Food and drug administration, USA.
|May 2005 - FDA issues alert to HealthCare Professionals )
FDA ALERT – [05/2005]: Reports of Suicide or Suicide Attempts FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. A section on the Data available to the FDA is included:
Data Summary: Some of the serious adverse event reports FDA
has received regarding isotretinoin include birth defects
and psychiatric effects (i.e., suicide ideation and suicide).
Isotretinoin is a well established teratogen. Although causality
has not been established for isotretinoin and psychiatric
events, the following information is important to consider:
- Preclinical and neuroimaging data suggest that isotretinoin
produces behavioral effects (i.e. activation) in rats,
impairment of neuronal division in the murine hippocampus,
and reductions in orbitofrontal brain metabolic rates
in humans. This preclinical and neuroimaging data may
suggest biological plausibility for the suspected psychiatric
adverse events associated with isotretinoin.
- From isotretinoin’s initial marketing in 1982 through
August 2004, 4,992 spontaneous reports of psychiatric
disturbances associated with using isotretinoin in patients
in the United States have been submitted to the FDA.
- The number of reported suicides among isotretinoin users
in the United States was 190 through January 2005. Between
1982 and 2002, there were 165 reported suicides, which
were fewer than the 220 predicted based on U.S. vital
statistics data. However, because the degree of under-reporting
of suicides is unknown, the fact that the reported number
is lower than the predicted number cannot be interpreted
as evidence against a causal association.
25 February 1998 - IMPORTANT NEW SAFETY INFORMATION ABOUT ACCUTANE
FDA today is advising consumers and health care providers
of new safety information regarding the prescription anti-acne
drug Accutane (isotretinoin) and isolated reports of depression,
psychosis and rarely suicidal thoughts and actions.
UK - Medicines and Healthcare products Regulatory Agency (MHRA)
|In September 2004 the label warnings were strengthened to
include more explicit descriptions of the symptoms and behaviours
associated with psychiatric disorders. The Expert Working
Group within the Committee of Safety of Medicines (CSM) continue
to access the latest evidence of psychiatric disorders suspected
to be associated with Roaccutane.
EMEA - European Medicines Agency
The product information for isotretinoin products was updated
following a European wide review of product information on
17 October 2003. See label
warning section of this website
|On March 5th 1998, the FDA sent a warning letter to Roche for placing
scientific journal advertisements which stated that Roaccutane "will
minimize or improve the patient's psychosocial status, including depression",
which the FDA believed to be "false or misleading and promote Accutane
for an unapproved use.." This warning occurred within weeks after
US suicide warning for Roaccutane was introduced in February 1998.
In this warning letter, FDA state that "Roche, however, has not systemically
studied the ability of Roccutane to modify or prevent such illnesses
as depression and has presented no basis for asserting that Accutane
is effective in improving the psychosocial and emotional well-being
of such patients". Click
here for warning letter
On the 25th July 2002 the FDA sent a warning letter to Roche for false
or misleading statements and minimization of important risk information.
A representative of Roche made false or misleading oral statements
about Accutane (isotretinoin) Capsules at Roche's promotional exhibit
booth at the American Pharmaceutical Association's (APhA) Annual Meeting
and Exposition held in Philadelphia, Pennsylvania in March 2002. Roche's
representative engaged in false or misleading promotional activities
about a bolded warning and other risk information relating to psychiatric
disorders in Accutane's approved product labeling (PI). The representative's
oral statements raise significant public health and safety concerns
because they minimize the risk of psychiatric disorders that can occur
with Accutane therapy and misleadingly suggest that the drug is safer
than has been demonstrated by substantial evidence...click
here for warning letter