HL Deb 30 October 1997 vol 582 cc252-3WA
The Countess of Mar

asked Her Majesty's Government:

Further to the Written Answer given by Lord Donoughue on 30 July (WA 54), what were the signs and symptoms of the 410 reported adverse reactions to products containing vitamin B6 alone and what clinical investigations were made as to pre-existing medical conditions or co-exposure;

Further to the Written Answer given by Lord Donoughue on 30 July (WA 54), whether all the 649 adverse reaction reports to products containing vitamin B6 between 1964 and 1997 were confined to the United Kingdom, and if not, from which other countries were reports included; and

Whether any of the fatalities associated with vitamin B6 were associated with patients suffering from tuberculosis and receiving isoniazid.

Baroness Jay of Paddington

A Drug Analysis Print (DAP), listing signs and symptoms associated with all suspected reactions reported to the Committee on Safety of Medicines between 1 July 1963 and 30 July 1997 for products containing vitamin B6 has been placed in the Library along with an information sheet to aid interpretation.

The yellow cards completed by physicians in order to report suspected adverse drug reactions have sections where the reporting doctor can indicate any details of pre-existing conditions and co-exposure that he feels may be relevant to the report.

The 411 reactions now reported to have occurred in this period (one further report of a reaction during this period has been received) originated from 160 spontaneous reports. Of these 11 reports had more than one drug listed as suspected to have caused the reaction, 78 reports had details of other medications not suspected to be related to the reaction, and five included information on pre-existing conditions. Clinical investigations are at the discretion of the reporting physician.

All 649 reports referred to the Written Answer given by Lord Donoughue on 30 July at column WA 54 were from the United Kingdom.

There was one fatality associated with vitamin B6 in a patient suffering from tuberculosis, who was receiving a combination of rifampicin and isoniazid.