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Dáil Éireann debate -
Thursday, 16 Nov 2000

Vol. 526 No. 2

Written Answers. - Cold and 'Flu Remedies.

Liam Lawlor

Question:

97 Mr. Lawlor asked the Minister for Health and Children the plans he has to review the safety of certain colds and 'flu remedies removed from the shelves of at least one pharmacy chain following research findings in the United States suggesting the heightened risk of brain haemorrhage from the use of these patent remedies. [26174/00]

The Irish Medicines Board has been in touch with the FDA, the United States regulatory authority, concerning the research findings and issued a number of press statements in relation to the matter as updated information became available, the latest of which issued on 14 November 2000. The matter is being kept under continuous review and any regulatory action deemed necessary will be taken.

The study in the United States, which took place at Yale University School of Medicine, identified an association between the use of phenylpropanolamine, PPA, and the occurrence of haemorrhagic stroke in women. The use of this ingredient in the United States is quite different to that in Ireland. In the United States, products containing this ingredient are used for weight control, as appetite suppressants, which is not an authorised indication in Ireland. Similarly, the doses used for weight control are much higher than those recommended for the treatment of coughs and colds.
There are currently 18 phenylpropanolamine containing medicinal products authorised for use as cold remedies in Ireland, some of which have been authorised for more than 20 years. To date, no reports of suspected stroke occurring in Ireland have been notified to the Irish Medicines Board associated with use of these products.
Following initial review of the data and in the context of use in Ireland, the Irish Medicines Board does not consider that there is a need to withdraw these products from the marketplace at this time. The Irish Medicines Board is aware that some pharmaceutical companies, following corporate negotiations with their parent groups may withdraw their PPA-containing products from the Irish marketplace for business reasons.
As always, the Irish Medicines Board recommends that patients read carefully the instructions on the packaging and patient information leaflets supplied with these products. In particular, the daily recommended dose should not be exceeded. Patients should consult their doctor or pharmacist with any problems or uncertainties.
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