Manufacturer Boehringer Ingelheim has been found guilty of breaching the pharmaceutical industry's code of practice for promoting an unlicensed indication of Pradaxa (dabigatran) to the public.

The Prescription Medicines Code of Practice Authority (PMCPA) ruled that Boehringer Ingelheim had breached advertising standards, following a complaint that newspapers had made "exaggerated claims" about Pradaxa.

Boehringer Ingelheim maintained it had "accurately" presented facts about the drug to the media, but the PMCPA panel ruled that it was "very concerned" about Boehringer Ingelheim's press materials.

The complaint arose after coverage in national newspapers suggested that Pradaxa could be used to prevent stroke among patients with atrial fibrillation. Newspapers described Pradaxa as a "super pill" and a "revolutionary drug", with one article claiming it prevented clots "better than warfarin but with less bleeding".

A GP complained that the articles would encourage patients to ask for the drug and highlighted that Pradaxa was not licensed to prevent strokes in this particular patient group. The complainant added that, in one article, competitor drug warfarin was referred to as "rat poison".

Boehringer Ingelheim "strongly refuted" claims that it had promoted an unlicensed indication of Pradaxa, stressing that it had "clearly stated that Pradaxa was unlicensed for stroke prevention in atrial fibrillation". It added that all the data included in its press releases was from a 2009 clinical study, which compared the effects of Pradaxa with warfarin in this patient group.

The PCMPA panel stated that Boehringer Ingelheim's press materials had referred to Pradaxa reducing the risk of stroke in patients with atrial fibrillation. The press releases did not mention the risk of "major haemorrhage or any other adverse event" and failed to clarify that Pradaxa was not authorised for use in this context, it said.

And although the manufacturer had not made any "disparaging remarks" about warfarin in its press materials, the panel expressed concern over the "very positive" statements made in the ‘Notes to Editors' section of its press release. The press release described Pradaxa as "leading the way in new oral anticoagulants" and "targeting an unmet need" – claims that were queried by the PCMPA panel.

The panel ruled that Boehringer Ingelheim had "promoted a prescription-only medicine to the public in an indication that was not yet licensed". It added that the press materials had "brought discredit upon, and reduced confidence in" the industry and had failed to meet advertising standards.