CSM Curbs Terfenadine Use In UK

4 May 1997

The UK Committee on Safety of Medicines has recommended that steps betaken to ensure that hay fever products containing terfenadine be made prescription-only, following its review of the drug's safety in relation to rare, but fatal, cardiac arrythmias which have occurred under certain circumstances. Since 1982, terfenadine has been linked to 14 deaths in the UK.

The proposal is, however, subject to a three-month consultation period, and in the interim the product will still be available over-the-counter. Precautions for its safe use have been issued by the CSM, which says that it should not be used if the patient has heart or liver problems, that it should not be taken in combination with other medicines including erythromycin and ketoconazole, and that it should not be taken with grapefruit juice. The CSM advised that pharmacists should take products containing terfenadine off display, that only the pharmacist sells products containing terfenadine (and astemizole), and that the CSM patient information sheet be given to patients for whom terfenadine products are appropriate.

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