“Fatal exacerbation” among certain asthma sufferers

[11 January 2007 - 15h57]

The use of certain bronchodilators without associated corticoid treatment “may bring on a more serious asthma attack that could prove fatal”. This warning supported “by a high level of evidence (…) is gathering strength” according to the journal Prescrire.

This information – which we can see that the French authorities are taking very seriously – is not new. More than 16 months ago Destination Santé revealed that salmeterol and formoterol had been placed on the Index by the US Food and Drug Administration (FDA) following the publication in the United States of the SMART study (an acronym for the Salmeterol Multi-center Asthma Research Trial). Marketed under the names Serevent and Foradil in Europe, these long-acting bronchodilators had proved to be dangerous when used without an associated anti-inflammatory corticoid, which is the primary therapy for asthma.

The danger is real and translates into exacerbation of the asthmatic condition that can prove fatal. This was confirmed by the introduction of marketing restrictions and obligatory information requirements on manufacturers. At the time, Professor Jean Bousquet, Director of the WHO asthma collaboration centre at Montpellier, stressed the need for caution. “If an asthma sufferer feels that his condition is not stable, if his medication requirements increase, he should see his doctor” he told us.

Never without cortisone

The GSK laboratory, which produces Serevent, chose not to reply to our questions. On the other hand, Novartis France, which produces Foradil, was more transparent. “We rely on information from health professionals. And lung specialists in particular”, explained Patrick Bonduelle, director of external relations. The company also pointed out that it has access to pharmacovigilance data “relating to over 13 million patient-years since 1990 and which demonstrate the good safety record of Foradil in the treatment of asthma. Within the framework of recommendations on good practice, of course.

In France, in principle at least, these bronchodilators are never used without cortisone. However, as Prescrire points out, “a study conducted in 2002 by the Rhône-Alpes Regional Health Insurance Agency, URCAM, showed that 9.3% of patients aged between 5 and 40 who had received reimbursement for one (of these bronchodilators) had not applied for reimbursement of a corticoid”. As there are 3.5 million asthma sufferers in France this gives some idea of the numbers at risk.

Carmen Kreft-Jaïs, in charge of pharmacovigilance at the French Health Products Safety Agency, the AFSSaPS, tells us, “We have been monitoring this matter since the first results of the SMART study. … We decided in the light of these authoritative data to change the Product Characteristics Summary of salmeterol (Serevent - editor’s note) by including the results of the study”.

This change will take place during the coming months. And Carmen Kreft-Jaïs further stresses the importance of using medication correctly, pointing out that in France “bronchodilators must always be used in association with a corticoid in the treatment of asthma. That is what is required”.

Source : The journal Prescrire, January 2007 Volume 27, No. 279, pp. 23-24, FDA, Public Citizen, Jean Bousquet interview, 25 September 2005, Carmen Kreft-Jaïs interview, 10 January 2007, Patrick Bonduelle interview, 4 January 2007

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