HC Deb 17 June 1985 vol 81 cc46-7W
Mr. Ashley

asked the Secretary of State for Social Services, pursuant to his answer of 24 May, Official Report, column 595, if he will categorise the 29 and 527 adverse reaction reports related to products containing only vitamin B6 pyridoxine, and to combination products containing pyridoxine and other ingredients, respectively, according to the year of the report and the nature of the adverse reaction.

Mr. Kenneth Clarke

The information requested is in the following tables. The Committee on Safety of Medicines has now received 528 reports relating to combination products containing pyridoxine. The date a report is received does not necessarily indicate the year in which the suspected adverse reaction occurred. It is very important to bear in mind that a report does not necessarily

Combination products containing pyridoxine—Reports of suspected adverse reactions received by CSM by year and type of reaction
System Organ Class 1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985
Application Site Disorders 1 1 1
Arrhythmias 1 1
Auditory, and Vestibular 1 1
Autonomic Nervous System 3 1 2 1 2 2 1
Bleeding and Clotting Disorders 1 1
Cardiovascular Disorders 1
Central Nervous System 1 1 2 1 2 2 4 5 1 4 6 3 2 5 1 3
Endocrine Disorders 1
Female Reproductive Disorders 1 2 1 1
Fetal disorders 1 11 5 6 5 12 4 3 10 6 8 4 4 12 13 14 103 19 8 15 5 4
Gastro Intestinal Disorders 3 1 2 1 3 3 1 1 1 3 1
General Disorders 1 1 1 2 1 2 4 3 4 3 7 8 1
Hepatic Disorders 1 2 1 1 1 1 1 2
Intra-Cardiac Disorders 1
Male Reproductive Disorders 1
Metabolic and Nutritional 1 1
Muscular Skeletal Disorders 1
Neonatal and Childhood 1
Neoplasms 1
Other Special Senses 1
Peripheral Vascular Disorders 1 1 1 2 2 2 1
Psychiatric Disorders 2 2 1 4 2 1 4 4 2 2 4 2 1 2
Red Blood Cell Disorders 1 1 1
Respiratory Disorders 1 2 2 2 1
Skin and Appendages 2 3 1 1 1 1 1 2 3 1 4 3 2 3 3 3 2 3 1
Urinary Disorders 1 2 2
Visual Disorders 1 1 1 2 1 1 1
White Blood Cell Disorders 1 1

Products containing pyridoxine only—Reports of suspected adverse reactions received by CSM by year and type of reaction
System Organ Class 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985
Autonomic Nervous System 1 1
Bleeding and Clotting Disorders 1
Central Nervous System 1 1 2 1 2 1
Female Reproductive Disorders 1
Fetal Disorders 1 1
Gastro-Intestinal Disorders 1 1 1
General Disorders 1
Psychiatric Disorders 3 1 1
Skin and Appendages 2 1 2
Visual Disorders 1