AUTH/3293/1/20 - Anonymous v Boehringer Ingelheim

Promotion of Pradaxa

  • Received
    30 December 2020
  • Case number
  • Applicable Code year
  • Completed
    18 December 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous individual, who described him/herself as a health professional, complained about the promotion of Pradaxa (dabigatran) by Boehringer Ingelheim Limited. Pradaxa was an anticoagulant indicated for the prevention and treatment of certain thrombotic conditions.

The complainant alleged that the claim ‘in any patient at increased risk of bleeding’ could not be substantiated as the summary of product characteristics (SPC) stated that the medicine could not be used when renal function was severely impaired (CrCl <30mL/min) eg in elderly patients who were often initiated on Pradaxa. The complainant alleged a breach of the Code and referred to a risk to patient safety.

The complainant provided no details of the material in which the claim had been used nor of the context in which it had appeared.

The detailed response from Boehringer Ingelheim is given below.

The Panel noted that complainants had the burden of proving their complaints on the balance of probabilities. Complaints were judged on the evidence provided by the parties. The complainant had not referred to any promotional material or provided any details as to the context in which he/she had seen the claim at issue. As the complainant could not be contacted on the email address provided, further details from him/her could not be requested. The Panel noted, however, that Boehringer Ingelheim had provided a copy of the landing page to its website (ref PC-UK-101787 V1) which it stated was current when the complaint was submitted (30 December 2019) and so it was this material upon which the Panel based its rulings.

The Panel noted that the landing page for Boehringer Ingelheim’s Pradaxa 110mg website included the claim ‘Pradaxa 110 is the only low-dose [novel oral anticoagulant] for stroke prevention in atrial fibrillation recommended for use in any patient at increased risk of bleeding*’. Immediately below the claim in small font was the statement ‘See how to select the right dose of Pradaxa’ which appeared to be a link to further information. The asterisk took the reader to a footnote, in similarly small font which read ‘Pradaxa 110 is also recommended for patients over 80 years of age and patients currently treated with verapamil’. The Panel considered that a busy health professional reading the website would assume that Pradaxa 110mg could be prescribed to all patients at increased risk of bleeding which was not so; it was contraindicated in those with severe renal impairment. That a link to further information had been provided was, in the Panel’s view, irrelevant – it was an accepted principle under the Code that claims had to be capable of standing alone without recourse to footnotes and the like. The Panel noted, with concern, the reference to the over 80s in the footnote given that the risk of renal impairment increased with age. The Panel considered that the claim was misleading, and a breach of the Code was ruled.

The Panel considered that Boehringer Ingelheim had failed to maintain high standards and a breach of the Code was ruled.

The Panel considered that there was a risk that some patients with severe renal impairment might be inappropriately treated with Pradaxa 110mg. The Panel considered that patient safety was of the utmost importance and that Boehringer Ingelheim’s claim that Pradaxa 110mg could be used in any patient at increased risk of bleeding brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled.