§ Mr. Patrick ThompsonTo ask the Secretary of State for Health if he is satisfied with the safety of the drug Duromine; and what evidence he has of adverse short-term side effects among patients taking it.
§ Mrs. Virginia BottomleyFollowing the introduction of licensing of medicinal products, the safety of Duromine, an established product, was reviewed and a reviewed product licence was issued in 1984. The licensed use is restricted to short-term administration as an adjunct to the treatment of moderate to severe obesity of some patients for whom close control and supervision should be provided. As the product is a prescription medicine, it would be used only after the prescriber had weighed the expected benefit against the possible risks to the particular patient. I am satisfied that the product, when used in accordance with the licensed particulars, should not expose the patient to an unacceptable level of risk.
Potentially, any drug may cause side-effects which may be minor or more serious. The established side-effects that are associated with a licensed medicinal product are detailed in the licence and are provided to prescribers in the data sheet distributed by the company marketing the product. The Committee on Safety of Medicines encourages prescribers to report serious adverse reactions which they suspect may have been due to an established drug and all reactions to new drugs. In the case of Duromine, there have been 61 reports of suspected adverse reactions since 1966; reactions are not classified into long and short-term effects. The report of an adverse reaction does not necessarily imply a causal effect. Information on adverse effects to Duromine is also to be found in published medical literature.