Corwin (Hansard, 21 June 1990)

§ Sir Michael McNair-Wilson
To ask the Secretary of State for Health what discussions have been held between the medical profession and the Committee on Safety of Medicines about withdrawing the heart drug Corwin; and if he will make a statement.

§ Mrs. Virginia Bottomley
Information on the quality, efficacy and safety of Corwin was rigorously assessed by the Committee on Safety of Medicines (CSM) prior to the granting of a product licence. It was placed on the market in May 1988, licensed for the treatment of mild to moderate heart failure. It was clearly recommended that the drug should not be used in severe heart failure as it had not shown benefit in these patients.
Corwin has been carefully monitored since its introduction on to the market and the CSM has collected and assessed extensive information on the effects of the product. In 1989 the findings of a clinical trial showed that the drug could cause deterioration in patients with severe heart failure; other information from the yellow card adverse drug reaction monitoring scheme indicated that it was sometimes being used inappropriately in such patients. A letter from ICI Pharmaceuticals, which markets the product, was sent to all doctors in August 1989 warning them of the dangers of the use of the product in severe heart failure, clearly defining those patients who should not be given the drug. The product's data sheet was amended accordingly.
In January 1990, on the basis of further information, the CSM made recommendations severely restricting the use of Corwin. Doctors were informed of this advice in a letter from ICI Pharmaceuticals and in the CSM bulletin "Current Problems" No. 28 of May 1990, a copy of which is available in the Library. The CSM is satisfied that the product can be used safely if these recommendations are followed, but will continue to monitor the situation.

§ Mr. Alex Carlile
To ask the Secretary of State for Health if he will make a statement on the number of prescriptions involving use of the drug Corwin.
676W

§ Mrs. Virginia Bottomley
Available figures relate to the issue of prescriptions in England, in 1988, and are based on a sample of all prescriptions. Prescriptions issued for Corwin were 3,800 and for Xamoterol the generic equivalent were 1,420.

§ Mr. Alex Carlile
To ask the Secretary of State for Health what information he has on deaths connected with the use of the drug Corwin; and if he will make a statement.

§ Mrs. Virginia Bottomley
The Committee on Safety of Medicines CSM has received 29 spontaneous reports under the yellow card scheme of deaths occurring in patients receiving treatment with Corwin. The report of a suspected reaction does not necessarily imply a causal association with the drug. In the case of patients treated with Corwin, the majority of those who died were critically ill and receiving a number of concurrent drugs.
In a clinical trial carried out in severe heart failure, the findings suggested a 2.5-fold greater mortality in association with Corwin compared to the group given no drug treatment.
As a result of this study's findings the CSM has recommended restrictions on the use of Corwin to ensure it is not used in patients with moderate to severe heart failure but only in patients with mild heart failure who benefit from treatment. Doctors and pharmacists were informed of these restrictions by the CSM's "Current Problems" bulletin distributed in May 1990, a copy of which is available in the Library.