§ Mr. FlynnTo ask the Secretary of State for Health what reports he has received of adverse reactions following the use of the anti-acne drug Roaccutane/Accutane; and if he will make a statement. [42061]
§ Ms Jowell[pursuant to her reply, 18 May 1998, c. 267]: 1 regret the number of prescriptions quoted in my previous reply was incorrect. This information was derived from data held by the Prescription Pricing Authority which cover only prescriptions written by general practitioners. There is no national scheme for gathering drug usage in hospitals; hence the estimate for the use of Roaccutane has been derived from sales figures. The majority of prescriptions for Roaccutane are written in hospitals; therefore the previous estimate of 11,000 prescriptions underestimates the true usage.
Information from the manufacturer provides an estimate of 136,563 prescriptions for Roaccutane covering the period 1993 to 1997 in the United Kingdom. These prescriptions cover both general practice and hospital usage. During this period, the Medicines Control Agency/Committee on Safety of Medicines have received a total of 280 reports covering 467 suspected adverse reactions reported in association with Roaccutane therapy. These reports cover a range of effects; the most frequently reported include skin and subcutaneous tissue reactions, musculoskeletal disorders and gastrointestinal disorders.
Roaccutane (oral isotretinoin) is available only on prescription for the treatment of severe acne which has failed to respond to antibiotics. It is recommended for use
1995–96 1996–97 1997–98 Great Britain Total number of decisions following application of the all work test (AWT)1 914,656 1,270,284 1,237,982 Number disallowed following application of the AWT2 105,027 208,981 222,290 Number of appeals received against a decision on the AWT 40,665 91,550 n/a Number of decisions in appellant's favour 4,122 31,036 n/a Leaside District3 Total decisions following application of the AWT1 5,494 6,091 6,946 Number disallowed following application of the AWT2 438 1,380 1,192 1Includes some Severe Disablement Allowance cases and a few decisions following application of the Own Occupation Test of incapacity 2 Includes disallowances following failure to return the all work test questionnaire or failure to attend medical examination without good cause 3 Leaside District includes the Benefits Agency local offices of Edmonton, Wood Green and Tottenham Sources:
100 per cent. count of the Incapacity Benefit Computer System, Benefits Agency and Independent Tribunal Service