Advertising complaint - Fostair (beclometasone dipropionate/formoterol), MIMS February 2008

A healthcare professional complained to the MHRA about an advertisement issued by Trinity-Chiesi and the product listing for Fostair published in MIMS February 2008. The complainant was concerned that, unlike the product listing for Qvar which made reference to the dose being lower than for other beclometasone dipropionate (BDP) products, the product listing and advertisement for Fostair were misleading as they did not make it clear that the required dose for Fostair was lower than for “traditional” BDP products.

The MHRA did not uphold the complaint about the MIMS product listing as it did not constitute advertising under the terms of the Regulations. Editorial responsibility for the product listing for Fostair remained with the publishers. The MHRA wrote to MIMS to alert them to the issue and received confirmation from MIMS that they would include a note in the product listing about the dosing difference between Fostair and standard BDP products.

In response to a request from the MHRA, Trinity-Chiesi agreed to include the relevant information in the prescribing information (PI) of future advertising.

Section 4.2 of the Summary of Product Characteristics for Fostair states that “Beclometasone dipropionate in Fostair is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of beclometasone dipropionate with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Fostair are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation). Therefore the total daily dose of beclometasone dipropionate administered in Fostair should be lower than the total daily dose of beclometasone dipropionate administered in a non-extrafine beclometasone dipropionate formulation”.

Following a review of the advertisement in response to the public health concerns raised by the complainant, the MHRA considered that Trinity-Chiesi should have been asked to include this information in the PI during the earlier vetting exercise for Fostair advertising, to promote safe use of the product.