HC Deb 14 February 1997 vol 290 c352W
Ms Corston

To ask the Secretary of State for Health what his Department define as severe, moderate and slight side effects of the drug Lariam; what other definitions of the severity of side effects have been put to him by(a) the manufacturer of the drug and (b) independent scientists; what information he has obtained on the rates of incidence of these side effects; and to what extent the rate of incidence calculated by different parties varies. [15202]

Mr. Malone

There are no internationally defined standards for defining the severity of side effects; therefore the Department does not categorise the side effects of medicines, including Lariam, as severe, moderate or slight. Clinicians assess the rates of incidence of side effects from their patients and report to the Medicines Control Agency on a yellow card.

Information on the incidence of the side effects of Lariam is available from various clinical studies. Different criteria and methodologies are used for the definition of the severity of an adverse reaction. However, these studies show that serious adverse reactions are rare.