Roaccutane, also known as Accutane, isotretintoin or 3-cis retinoic acid, is well recognised as an effective therapy for treatment of severe acne. The precise mechanism of action of Roaccutane, however, is unknown. The licence for Roaccutane states that the drug is indicated for severe acne that is non-responsive to conventional therapy and is available as a hospital-only prescription. Therapeutic response to Roaccutane is usually excellent but, unfortunately, it is not free of side effects. It is, for example, a well known and potent teratogen. It also causes an increase in serum lipids. A Medline search of the scientific literature of Roaccutane therapy and its effects reveals a number of cases of psychological distress associated with the drug. Suicide and suicide attempts in association with Roaccutane therapy have also been reported.
Concerns about the safety of Roaccutane have been raised in the past and in May 1998, data provided by the manufacturers, Roche, revealed that a total of 170 cases of suicide, suicide attempt or suicide ideation were reported as associated with the drug. It also reported at the same time that, overall, 40,000 adverse drug reactions were known to it but the nature of these adverse drug reactions was not made available.
In February 1998, the FDA issued a talk paper declaring new safety information regarding Roaccutane as a result of adverse event reports which the agency had received. Almost one year prior to the US revision, the French product label was altered in March 1997 to include suicide attempt as a side effect of Roaccutane. It reads, "In rare cases neuropsychological problems have been recorded – behavioural difficulties, depression, convulsions and suicide attempts". Revised warnings have been introduced in Ireland and Britain since 1998.
A number of scientific papers have been published on the association between Roaccutane and depression. Lamberg in 1998 in the Journal of the American Medical Association published a paper entitled Acne drug depression warnings highlight the need for expert care; Aubin et al in 1995 in Clinical Experimental Dermatology wrote an article entitled Massive isotretinoin intoxication and Scheimal et al in 1990, in the Journal of the American Academy of Dermatology, wrote an article entitled Acute depression from isotretinoin. These are just some examples of the available scientific publications.
The position of the manufacturer of the drug, as of April 1999, remains that there is no scientific evidence of a link between Roaccutane, depression and suicide. It is worthy of note, however, that the British Government has granted legal aid to finance claims on civil actions against manufacturers in relation to psychiatric side effects of Roaccutane. This is likely to cost the British Government many millions in the financing of free legal fees, scientific studies and the availability of professional witnesses.
Is the Minister aware that Roaccutane may be purchased in Ireland over the Internet? This is the same drug that, according to the manufacturers, should be available on hospital-only prescription and available only for severe acne. It is deeply disturbing that this drug can be ordered in this fashion, effectively without any control. It should be noted, however, that Roaccutane purchased over the Internet did contain a list of side effects and special precautions, including the following: "Behavioural disorders or seizures have been observed. In the post-marketing period a number of patients have reported depression, psychosis and, rarely, suicide ideation, suicide attempts and suicide. Of the patients reporting depression, some reported that the depression subsided with the discontinuation of the treatment and re-emerged on resumption of treatment". This information is available with the product on sale in South Africa.
Will the Minister ensure that the Irish Medicines Board will have available from the manufacturers of the drug the full list of adverse drug reactions reports held on the Roche database, to show the number and nature of side effects reported to be caused by this drug? Will the Minister make this information available to me and to other persons with an interest in the side effects of the drug?
Will the Minister agree to set up an independent, scientific inquiry to review the side effects caused by Roaccutane, to interview users and their families who have experienced side effects from the use of the drug, to review the medical data, to report if present warnings should be significantly strengthened and to consider the introduction of some form of psychiatric monitoring of patients throughout treatment on Roaccutane?