AUTH/3313/2/20 - Complainant v Tillotts

Promotion of Octasa

  • Received
    20 February 2020
  • Case number
  • Applicable Code year
  • Completed
    07 January 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK health professional, complained about an Octasa 1600mg (modified release mesalazine) journal advertisement) placed by Tillotts Pharma UK Limited. The advertisement was headed ‘Big picture thinking’ and featured the photograph of an elderly man who appeared to be holding three photographs of himself spanning the years to when he was a young man/boy. The main claim was ‘Always once-daily designed to aid adherence’.

Octasa 1600mg was indicated for the treatment of mild to moderate ulcerative colitis and for the maintenance of remission.

The complainant alleged that although the advertisement claimed ‘Always once a day’, the summary of product characteristics (SPC) stated that in acute disease the dose could be given 2-3 times a day.

In the complainant’s view, the boy in the inner picture appeared to be under the age of 18. Although the product was not excluded from this age group, safety and efficacy had not been excluded (sic) and in the picture it appeared it was equally suitable for all age groups, and there was also no text in the advertisement to convey this safety message.

The detailed response from Tillotts is given below.

The Panel noted that Octasa 1600mg modified release was indicated for adults andthe dose should be adjusted according to the severity of the disease and tolerance. For acute disease, in the event of exacerbation, the dose could be increased to 4800mg daily, once daily or in 2-3 divided doses and once clinical remission was achieved, the dose should gradually be decreased to maintenance dose. The maintenance dose was 1600mg once daily.

The Panel noted that the dose of 4800mg of Octasa did not have to be given as a split dose; patients could take three tablets together in a once daily dose. There was thus the possibility that Octasa 1600mg could always be given once daily.

The Panel noted that the advertisement might give some readers the impression that the medicine must only be given once daily whereas the SPC gave a choice in acute disease between once daily or divided doses. the Panel noted that the focus of the advertisement was on the maintenance of remission and as the indicated dose for maintenance of remission was one 1600mg tablet daily, and tablets must be swallowed whole, maintenance treatment was, by necessity, always once daily.

On balance the Panel considered that the claim at issue, ‘Always once daily’, was not inaccurate as such. The advertisement did not refer to the possibility in acute disease of taking the medicine in 2-3 doses but this did not render the claim misleading. The claim was capable of substantiation. The Panel therefore ruled no breaches of the Code.

With regard to the photograph of the youngest man/boy, in the advertisement, the Panel noted Tillotts’ submission that the peak incidence of ulcerative colitis occurred in the age range 15 to 25 years of age and that the model used for the inner image in the advertisement was 16 years old when the photograph was taken.

According to their SPCs Octasa 400mg and 800mg modified release tablets were indicated for children above the age of 6 with a maximum maintenance daily dose of 2g. The normal adult dose was recommended for those with a body weight of above 40kg. It appeared that the use and safety of mesalazine for treating ulcerative colitis in paediatric patients was well established, with a mg/kg of body weight ratio. However, Octasa 1600mg was only indicated for adults including the elderly and the SPC stated that the safety and efficacy of Octasa in children and adolescents aged younger than 18 years of age had not been established.

In the Panel’s view, the age of the man/boy in the smallest photograph at issue was difficult to determine but most would think he was a late teenager/young adult. The other two photographs were clearly of adult males. The theme of the advertisement was that the condition was lifelong. Health professionals would have to decide whether patients were suitable for the product and one of the factors to be considered would be their age.

On balance the Panel did not consider that the advertisement promoted the use of Octasa 1600mg in children or that it was suitable for all age groups as alleged. The Panel therefore ruled no breach of the Code.

Given its rulings of no breaches of the Code, above the Panel did not consider that high standards had not been maintained and ruled accordingly, including that there was no breach of Clause 2 of the Code.