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A Post-Marketing Surveillance Study of Formoterol (Foradil®)1

Its Use in General Practice in England

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Abstract

Objective: At the time of marketing, experience of long-term use of prescription medicines in general clinical practice is limited. Postmarketing surveillance is particularly important at this time when medicines may be prescribed to large numbers of patients of all ages, for long-term use. Following marketing of formoterol (Foradil®) in the UK in 1996 we undertook a postmarketing surveillance study of formoterol use in general practice.

Design: A non-interventional observational cohort study was conducted using the technique of prescription-event monitoring. Exposure data were obtained from prescription details; outcome data from questionnaires sent to general practitioners approximately 12 months after the first prescription was dispensed for individual patients. Incidence rates were calculated for reported events, reasons for stopping treatment and outcomes of pregnancy were determined.

Results: Data were collected for 5777 patients aged 3 to 96 years, 65% of whom continued treatment for >12 months. Formoterol was prescribed ‘off label’, to 258 children, (4.5%) of the cohort. The most commonly reported events excluding those related to respiratory disease, were headache, tremor, palpitation, cramp and nausea/vomiting. These events were also among the more common reasons for stopping treatment and reported as suspected adverse drug reactions. 33 patients took formoterol during pregnancy. The cause of death was established for 186 of the 190 deaths (3% of cohort).

Conclusions: Formoterol appears to have been well tolerated by the majority of patients in this study. The most frequently reported adverse events were those known to be associated with β2-agonists, although the frequency of nausea/vomiting was greater than given in Summary of Product Characteristics.

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Acknowledgements

We would like to record our keen appreciation of the co-operation of the general practitioners and numerous other colleagues who have helped in this investigation. In addition we wish to thank Mrs Jacqui Barfoot for the preparation of this report and for co-ordinating the follow-up. We would also like to thank for their important participation: the Prescription Pricing Authority, the Health Authorities of England and the Office for National Statistics.

The Drug Safety Research Unit is a registered medical charity. It receives unconditional donations from a number of pharmaceutical companies. These companies have no say in the conduct of the studies and have no statistical or editorial control over the analysis or reporting of results. The Drug Safety Research Unit has received such funds from the manufacturers of formoterol.

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  1. Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Bursledon, Southampton, SO31 1AA, UK

    Lynda V. Wilton & Saad A. Shakir

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  1. Lynda V. Wilton
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  2. Saad A. Shakir
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Correspondence to Lynda V. Wilton.

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Wilton, L.V., Shakir, S.A. A Post-Marketing Surveillance Study of Formoterol (Foradil®)1 . Drug-Safety 25, 213–223 (2002). https://doi.org/10.2165/00002018-200225030-00006

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