HC Deb 20 January 2003 vol 398 cc143-5W
Clive Efford

To ask the Secretary of State for Health (1) when the Medical Control Agency will complete the review of the safety of Roaccutane; and what independent sources of information have been used by the Medical Control Agency in the assessment of the side effects of Roaccutane; [90766]

(2) what research has been undertaken into those suffering the most serious side effects of Roaccutane to identify those who may be vulnerable; and if he will review advice given to doctors and patients regarding the side effects of Roaccutane; [90767]

(3) how many reported cases of patients suffering side effects of Roaccutane there have been in each year since it was first prescribed.[90768]

Mr. Lammy

Roaccutane (isotretinoin), a vitamin A derivative for the treatment of severe acne, was launched on the United Kingdom market in 1983. The table provides a breakdown of the number of reports of suspected adverse reactions received each year through the Yellow Card Scheme for oral isotretinoin.

Year reaction occurred Number of reports
1983 10
1984 36
1985 59
1986 89
1987 75
1988 64
1989 36
1990 56
1991 44
1992 60
1993 57
1994 75
1995 56
1996 57
1997 64
1998 100
1999 82
2000 97
2001 65
2002 43

A report of a suspected adverse reaction does not necessarily mean that it was caused by the medicine. The number of reports received should not be used as a basis for determining the incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using the drug is known.

The safety of all medicines on the UK market is continuously monitored by the Medicines Control Agency (MCA) with independent expert advice from the Committee on Safety of Medicines (CSM). The sources of information used in this process include UK and foreign reports of suspected adverse reactions, published literature and unpublished studies, information on the level of drug prescribing, information received from other regulatory authorities throughout the world as well as information received from the marketing authorisation holder. There is a substantial body of published research on the safety of isotretinoin and a list of relevant publications has been placed in the House Library.

Warnings about risk factors are included in the summary of product characteristics (SPC) for prescribers and the patient information leaflet (PIL). The product information for oral isotretjnoin products states that it should not be used in patients with the following risk factors for side effects: known hypersensitivity (allergy) to the product, liver and kidney disease and in patients taking certain antibiotics (tetracyclines). In addition, isotretinoin should not be used during pregnancy because of the risk of major foetal abnormalities and should not be given to breast feeding women. Warnings are also present about a possible increase in the risk of side effects in patients with a history of depression, patients with diabetes, obesity, alcoholism or lipid metabolism disorders and asthmatic patients.

Advice about the side effects associated with the use of isotretinoin and the risk of teratogenicity (birth defects) has been issued to all doctors and pharmacists in the MCA/GSM bulletin "Current Problems in Pharmacovigilance" in October 1983, December 1997 and August 1998 as well as in the British National Formulary which is issued to health professionals twice a year.

The MCA is currently leading a European-wide review of the product information of isotretinoin products including Roaccutane, with the aim to ensure that up-to-date and consistent information is provided to health professionals and patients to optimise its safe use. This review is likely to take some months to complete. Any new advice will be communicated to health professionals and patients.