HC Deb 21 November 1991 vol 199 cc309-10W
Mr. Ashley

To ask the Secretary of State for Health if he will list by year the numbers of reports of(a) cardiac arrhythmias (fatal and non-fatal) and (b) other fatalities associated with pimozide which were reported to the licensing authority since it was first licensed; and indicate in all those cases the dose of pimozide used and types and doses of other anti-psychotic medicines which were taken at the same time as pimozide.

Mrs. Virginia Bottomley

There have been 29 yellow card reports of cardiac arrhythmias associated with the drug pimozide, of which 14 were fatal. The breakdown by year is as follows:

Year of Report Reports Fatalities
1971 2 —
1980 1 —
1984 1 —
1988 2 1
1989 2 1
1990 14 8
1991 7 4

There have been seven other fatalities associated with pimozide as follows:

Year of Report Fatalities
1972 1
1978 1
1980 3
1984 1
1986 1

The daily dose of pimozide and concurrent use of neuroleptic agents in the fatal reports is summarised as follows:

Daily dose (mg) Total Concurrent Neuroleptics
<10 5 2
11–20 2 2
21–30 2 —
31–40 5 4
41–50 2 1
51–60 2 2
61 + 3 2

I will write to the right hon. Member with full details of dose and other anti-psychotic medicines taken.

Mr. Ashley

To ask the Secretary of State for Health when doctors in the United Kingdom were recommended to reduce the maximum dosage of pimozide to 20 mg; and when he first became aware of the United States recommendation on this matter.

Mrs. Virginia Bottomley

In August 1990, the Committee on Safety of Medicines advised that a maximum daily dose of 20 mg should not be exceeded for the drug pimozide. This information was communicated to all doctors in the United Kingdom in issue No. 29 of the CSM bulletin "Current Problems", a copy of which is available in the Library. The company marketing the drug wrote to all doctors in October 1990 enclosing a copy of the revised data sheet and emphasising the change in prescribing information and the maximum recommended dose of 20 mg per day.

Revised dose recommendations made in the United States in 1988 related to use in a different medical condition, commonly prevalent in children, and not to use in schizophrenia and other psychoses, the main indication in the United Kingdom.