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Bayer cleared of Xarelto ‘breaches’

Published on 17/01/13 at 10:34am
Xarelto image

Bayer has been found not guilty of making multiple breaches of the ABPI Code of Practice following an anonymous complaint about the promotion of its anticoagulant Xarelto.

The PMCPA, which enforces the Code, was responding to an anonymous non-contactable person’s complaint about an 'outrageous' advert for the drug in GP magazine on 24 October 2012.

The two-page ad referred to the use of Xarelto (rivaroxaban) for stroke prevention in atrial fibrillation, saying 'One tablet, once daily, simple.'

The claim that Xarelto was 'simple' to use did not accurately reflect the inherent risks with anticoagulants nor was it consistent with the prescribing information, the complainant said.

A variety of cautions and contraindications are on the drug’s packaging, and calling it 'simple' was likely to “encourage inadequately considered or even inappropriate use with a consequent impact on patient safety”. 

The PMCPA panel disagreed: it thought the ad was clear that 'simple' only referred to the dosing regimen in this particular indication - not a claim that Xarelto was generally simple to use.

Health professionals, the likely readers of this advert, would be well aware of the complexities around the treatment, the panel said.

The Xarelto 20mg summary of product characteristics (SPC) - the recommended dose in this patient group - was also clear on dose adjustment and steps that should be taken for its safe administration in various cases.

The panel did not consider that the advert’s tagline was inconsistent with the SPC or an inaccurate reflection of the risks of using anticoagulants.

In short, it rejected any claim that Bayer’s promotion was inconsistent with the SPC (clause 3.2), that it was misleading (clause 7.2) and that the side effects of Xarelto were being brushed under the carpet (clause 7.9).

As a result the panel did not consider the company had failed to maintain high standards (clause 9.1) nor had it brought discredit to, or reduced confidence in, the pharmaceutical industry (clause 2). 

The findings will be published in the February 2013 Review.

Adam Hill

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