§ Baroness Whartonasked Her Majesty's Government:
What assessment they have made of the numbers of women who experience debilitation as a result of pre-menstrual tension; whether they have any information about the numbers of such women who supplement their diet with higher dose vitamin B6 supplements; and whether they have any evidence to suggest that in the last 10 years any such women have either died or otherwise suffered serious consequences from taking such supplements.
§ Baroness Jay of PaddingtonThe Government have no information on either the numbers of women who experience debilitation as a result of pre-menstrual tension or the total number of women supplementing their diet with high dose vitamin B6 preparations. Figures for prescribed medicines may be obtained but the number of women using vitamin B6 products without a prescription in unknown.
In the years 1987–96 the UK yellow card adverse drug reaction (ADR) reporting scheme administered by the Medicines Control Agency has received a total of 42 reactions associated with products containing only vitamin B6. Of these, for five women the indication for 109WA vitamin B6 was pre-menstrual tension, none of whom received more than 100 mg. per day. With the exception of one case of congenital malformation, all recovered.
Adverse reaction data from the UK's Yellow Card adverse drug reaction reporting scheme are provided voluntarily by doctors, dentists and pharmacists and indirectly by pharmaceutical companies. ADR reports relate to suspected adverse reactions associated with medicinal products. Officials have no information on the use of vitamin B6 as a food supplement. The inclusion of a reaction on the ADR database is not considered evidence that the medicine caused the reaction. Other factors such as the temporal relationship between medicine and reaction, any concomitant medication and the possibility of underlying disease should also be considered.