§ Mr. BlunkettTo ask the Secretary of State for Health what representations requesting compensation for side-effects she has received from patients who have taken the steroid prednisolone; and what action she is taking.
§ Mr. SackvilleSeveral representations have been received from patients who have taken steroids. Separate information is not held on representations made from those who have taken prednisolone. It is not the Department's policy to become involved in individual claims for compensation. This is a matter for individuals themselves to pursue with the companies concerned, if necessary, through the courts, as in other areas of health care.
§ Mr. BlunkettTo ask the Secretary of State for Health (1) what guidelines she has issued concerning the steroid prednisolone and its possible side-effects;
(2) what discussions she has had with the manufacturers of the steroid prednisolone concerning its possible side-effects.
§ Mr. SackvilleThe Department of Health has not issued specific guidelines about prednisolone. However, prescribing information on prednisolone and other corticosteroids is available to doctors in product data 215W sheets which are produced by the manufacturers and authorised by the licensing authority, and in the British National Formulary" which the Department of Health sends free to all prescribers. These provide extensive warnings about the side-effects of corticosteroids. Specific advice about the risk of immunosuppression in patients taking systemic corticosteroids and the association with disseminated chickenpox was recently sent to all doctors and pharmacists in the bulletin "Current Problems in Pharmacovigilance" volume 20: 1 February 1994, copies of which are available in the Library.
Following a review of the safety of corticosteroids by the Committee on Review of Medicines in the mid-1980s there were communications with the Association of the British Pharmaceutical Industry—ABPI—and individual companies, as a result prescribing information in product data sheets was revised. In the light of the recent recommendations made by the Committee on Safety of Medicines—CSM—regarding severe chickenpox in association with corticosteroids, the product information available for corticosteroids is being further revised. A large number of manufacturers are involved and will shortly be approached individually in writing on this matter.